Melbourne, Australia, June 28, 2022 – Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, wishes to advise that Dr Sud Agarwal has resigned as non-executive director.
Dr Agarwal’s key contribution to the Company was his strategic vision and foresight to originate Incannex’s proprietary cannabinoid combination drugs, IHL-42X, IHL-216A and IHL-675A (Combination Compounds). All pre-clinical and clinical studies undertaken to assess the Combination Compounds have been positive and the Company’s understanding of their medical and commercial potential has advanced significantly during Dr Agarwal’s tenure.
The clinical development activities associated with the Combination Compounds have been, and will continue to be managed by Chief Scientific Officer,Dr Mark Bleackley, who has been the Company’s lead contact with the U.S. Food and Drug Administration (‘FDA’) and all relevant regulatory bodies, with input from the medical and scientific advisory team and contracted clinical research organisations. All psychedelic research and development activities are managed and led by Dr Paul Liknaitzky and his team at Monash University, there will be no disruptions to the current operational structure of the development of the Company’s assets.
Appointments of Dr George Anastassov and Mr Lekhram Changoer With effect from the closing of Incannex’s acquisition of 100% of APIRx Pharmaceuticals, Dr George Anastassov, founding managing director of APIRx Pharmaceuticals, will replace Dr Agarwal on the board of directors. Co-founder of APIRx, Mr Lekhram Changoer (MSc) will join the Incannex management team as chief technology officer (CTO), responsible for the development and implementation of science and technical strategies for clinical and GMP-grade commercial manufacturing of pharmacotherapies.
Dr Anastassov and Mr Changoer will be employed by Incannex on a full-time basis. They will continue to drive the development of APIRx projects, whilst also being key members of the medical and scientific advisory team, assisting with the development of the Combination Compounds. Importantly for the progression of the Combination Compounds, Dr Anastassov and Mr Changoer are experienced with liaising and negotiating with FDA and the European Medicines Agency (EMA), having presented numerous regulatory submissions, including pre- investigational new drug (‘IND’) meeting packages and IND applications, to regulatory agencies over many years.
Furthermore, APIRx has strong relationships with international academic institutions and research hospitals including Mount Sinai School of Medicine, New York (USA), University of St. Andrews (UK), Free University of Amsterdam (NL), University of Wageningen (NL), and Mauritsclinics (NL). These relationships, among others, will be important to Incannex as all clinical research programs escalate.
Strategic rationale for collegial management adjustments Following research success in the Combination Compounds and the acquisition of APIRx pharmaceuticals, which has 22 distinct research and development projects, the board of directors recognise that the Company’s core strategic imperative to develop a diversified base of high-quality proprietary assets has been firmly established. The key imperative for Incannex now is the development of the Company’s proprietary drug candidates over which proof of concept has been established.
Further to the appointments of Dr Anastassov and Mr Changoer, a recruitment process is currently taking place for several full-time candidates with medical development and pharmaceutical commercialisation experience. Candidates from the United States are being sought.
Dr Agarwal’s resignation will also alleviate potential future conflict of interest issues pertaining to work undertaken by Cannvalate Pty Ltd, Dr Agarwal’s medicinal cannabis advisory firm. Dr Agarwal explained, “It is with some sadness that I move on from IHL and I wish the company success in it’s future drug development plans.”
Inncanex’s Managing Director and CEO, Mr Joel Latham said: “The Board of Incannex wishes to thank Dr Agarwal for his work on behalf of the Company and wishes him well for his future endeavours.”
This announcement has been approved for release to ASX by the Incannex board of directors.
IHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed
Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses
Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80%
Oxygen desaturation index was reduced by 59.7% relative to baseline while taking low dose IHL-42X, improving sleep quality and reducing cardiovascular stress
In low dose IHL-42X samples, THC concentrations in blood were well below the limits for impaired driving the morning after dose administration
IHL-42X was well tolerated – low dose IHL-42X was observed to have a lower number of total treatment emergent adverse events than placebo
Low dose IHL-42X reduced AHI substantially more effectively than is reported for the component active pharmaceutical ingredients, dronabinol and acetazolamide, as unregistered monotherapies.
MELBOURNE, Australia, June 3, 2022 /PRNewswire/ — Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed analysis of data from the phase 2 proof-of-concept clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea (‘OSA’). IHL-42X reduced apnoea hypopnoea index (‘AHI’), improved patient reported sleep quality and was well tolerated.
The clinical trial assessed three doses of IHL-42X at reducing the AHI in patients who suffered from OSA. Data was also collected for other aspects of sleep quality, THC clearance and safety. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. A total of eleven participants were recruited to the study and ten participants completed treatment periods. The crossover design of the study permitted Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant serves as their own internal control and inter-participant variation is eliminated. Data analysis was completed by Novotech, the contract research organisation responsible for management of the study, as well as the Incannex scientific research team, led by Chief Scientific Officer Dr Mark Bleackley. The findings of the clinical trial are presented below.
Effect of IHL-42X on apnoea hypopnoea index (AHI)
AHI is a measure of the number of times per hour a subject’s airway is blocked (apnoea) or partially blocked (hypopnoea). It is the main criteria used to diagnose and monitor OSA. AHI data was collected during overnight polysomnography on night seven of the treatment periods.
All doses of IHL-42X reduced AHI in patients with sleep apnoea compared to baseline (Table 1). This reduction was substantially greater than observed for placebo.
At the group level the difference relative to baseline with low dose and medium dose was statistically significant (p<0.05)
When comparing directly to baseline within subjects the difference in AHI compared to baseline between all three doses and placebo was statistically significant (p<0.001) (Table 2)
Low dose IHL-42X reduced AHI by >50% relative to baseline in 62.5% of subjects and by >80% in 25% of subjects (Table 2).
Low dose IHL-42X reduced AHI to the greatest extent at both the group level and when comparing the within subject reduction relative to baseline
Low dose IHL-42X reduced AHI to a greater extent than predicted based on published data for dronabinol and acetazolamide alone (Table 3).
The reduction in AHI observed during IHL-42X treatment periods means that when treated with Incannex’s proprietary drug, subject’s breathing was interrupted less frequently during sleep. This supports Incannex’s hypothesis that IHL-42X is an effective treatment for OSA. The observation that low dose IHL-42X was the most effective at reducing AHI is encouraging for the development of IHL-42X as a pharmaceutical as a lower dose will reduce risk of side effects and the cost of goods.
Furthermore, greater reduction in AHI with low dose IHL-42X compared to dronabinol and acetazolamide at equivalent doses supports Incannex’s hypothesis that the two drugs are acting synergistically to reduce AHI and provides confidence that IHL-42X will meet the FDA’s combination rule where both APIs must contribute to the therapeutic effect of a fixed dose combination product.
Table 1. Average AHI data for baseline and each treatment period
Baseline
Placebo
Low
Medium
High
Average AHI
42.84
40.08
21.13
22.22
27.78
Standard deviation
20.33
18.16
15.92
15.52
17.61
% Reduction relative to baseline
N/A
6.44
50.69
48.13
35.16
p value compared to baseline
N/A
0.76
0.029
0.031
0.12
Table 2. Change in AHI from baseline within subject (least square mean)
Average change in AHI from baseline
p-value relative to placebo (Bonferroni adjusted)
Proportion of subjects with AHI reduction >50% relative to baseline (%)
Proportion of subjects with AHI reduction >80% relative to baseline (%)
Placebo
1.95
N/A
10
0
Low
17.51
<0.001
62.5
25
Medium
14.86
<0.001
33.3
11.1
High
16.18
<0.001
22.2
11.1
Table 3. Comparison of reduction in AHI relative to baseline with low dose IHL-42X and the predicted reduction with component drugs as monotherapies at equivalent doses based on reported data.
Reduction in AHI compared to baseline (%)
2.5 mg dronabinol (1)
23.4
125 mg acetazolamide (2)
23.4
Low dose IHL-42X
50.7
Effect of IHL-42X on oxygen desaturation index (ODI)
Oxygen desaturation index (‘ODI’) is the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. Reduced oxygen uptake is a key component of the pathology of OSA and contributes to daytime sleepiness and the long-term health consequences associated with OSA. ODI data was collected during overnight polysomnography on night seven of the treatment periods.
All three doses of IHL-42X reduced ODI compared to baseline to a greater extent than placebo.
For low and medium dose IHL-42X the difference in reduction in ODI relative to baseline compared to placebo was statistically significant (p<0.05)
The greater reduction in ODI during IHL-42X treatment periods compared to placebo means that there is more oxygen in the subject’s blood during sleep while taking IHL-42X. This improves sleep quality and reduces risks of oxidative stress, bursts of the stress hormone cortisol, insulin resistance, altered metabolism and cardiovascular disease.
Table 4. Reduction in ODI compared to baseline during each treatment period.
Reduction in ODI relative to baseline (least squares mean)
Reduction in ODI relative to baseline (%)
p value compared to placebo (Bonferroni adjusted)
Placebo
1.8
18.3
N/A
Low
11.7
59.7
0.021
Medium
12
59.0
0.012
High
8.32
28.5
0.162
Plasma THC levels the morning after IHL-42X dosing
Countries that have set limits for THC above which driving is illegal have set those limits at 1-2 ng/mL (3-6). It is important to understand the clearance of THC after dosing with IHL-42X to determine where there will be an impact on ability to drive in countries where THC limits are in place. Plasma samples were collected 2 hours post dose 1 and the morning after dose 7 for each treatment period. Samples were analysed for concentration of THC using liquid chromatography with tandem mass spectrometry (LC-MS-MS).
The morning after dose 7, THC levels in the low dose IHL-42X samples had an average of 0.20 ng/mL and a maximum of 0.45 ng/mL. Both of which are below the thresholds for impaired driving. With medium and high dose IHL-42X the average THC concentrations the morning after dose 7 were 0.86 and 0.52 respectively.
Effect of IHL-42X on patient reported sleep quality
Each morning of the clinical trial, subjects recorded their sleep quality for the previous night as very poor, poor, fair, good, or very good. To compare patient reported sleep quality, the proportion of subjects who reported good or very good sleep each night was averaged across each treatment period. During the IHL-42X treatment periods subjects more frequently reported that their sleep quality was good or very good than placebo. The highest level of patient reported sleep quality was observed with low and high dose IHL-42X (Table 5).
Table 5. Patient reported sleep quality during each treatment period
Proportion of subjects reporting good or very good sleep quality
Placebo
26.50%
Low
49.49%
Medium
38.47%
High
50.13%
Sleep metrics captured by actigraphy
For the duration of the clinical trial, subjects wore an Actiwatch, a watch-like device that uses actigraphy to capture data on activity and sleep. IHL-42X at all doses improved sleep efficiency (what percentage of time in bed a subject is asleep), the number of awakenings per night, and the total minutes the subject was awake during the night (WASO) compared to placebo (Table 6). These improvements were greatest for low and high dose IHL-42X. This means that while taking IHL-42X subjects were asleep for a greater proportion of time they were in bed and woke up less often.
Table 6. Sleep metrics captured by actigraphy
Placebo
Low
Medium
High
Sleep efficiency
average
76.83
84.81
81.34
84.17
p value compared to placebo
N/A
0.0048
0.058
0.0078
Awakenings per night
average
49.31
35.8
41.44
37.33
p value compared to placebo
N/A
0.0053
0.055
0.012
WASO (min)
average
62.59
37.55
47.22
38.55
p value compared to placebo
NA
0.00011
0.0031
0.0010
Safety considerations
Adverse events were recorded from the time the subjects enrolled in the trial until their end of study visit. After recording of treatment emergent adverse events (TEAE) the study team, including investigators and medical monitors, reviewed the TEAEs to determine whether they were likely related to the investigational product. The TEAEs were consistent with what has been reported for dronabinol and acetazolamide alone. For each treatment period the proportion of subjects reporting one or more TEAEs (Table 7) as well as the total number of TEAEs (Table 8) were extracted from the clinical study report. Low dose IHL-42X had a similar proportion of subjects reporting TEAEs and a lower number of total TEAEs than placebo. This indicated that low dose IHL-42X is well tolerated.
Table 7. Proportion subjects of TEAEs reported for each treatment period
Placebo
Low
Medium
High
Total TEAE (%)
81.8
33.3
55.6
66.7
Related TEAE (%)
27.3
22.2
44.4
55.6
Table 8. Total number of TEAEs reported during each treatment period
Placebo
Low
Medium
High
Total TEAE
15
6
22
16
Related TEAE
7
4
16
12
References:
Carley DW, Prasad B, Reid KJ, Malkani R, Attarian H, Abbott SM, Vern B, Xie H, Yuan C, Zee PC. 2018. Pharmacotherapy of apnea by cannabimimetic enhancement, the PACE clinical trial: Effects of dronabinol in obstructive sleep apnea. Sleep 41.
Schmickl CN, Landry SA, Orr JE, Chin K, Murase K, Verbraecken J, Javaheri S, Edwards BA, Owens RL, Malhotra A. 2020. Acetazolamide for OSA and central sleep apnea: a comprehensive systematic review and meta-analysis. Chest 158:2632–2645.
Vindenes, V., et al., (2012) Impairment based legislative limits for driving under the influence of non-alcohol drugs in Norway, Forensic Science International 219(1-3,)1-11
Wolff, K, et al., Driving Under the Influence of Drugs: Report from the Expert Panel on Drug Driving, Department of Transport, London, 2013.
This announcement has been approved for release to ASX by the Incannex board of directors.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code “IHL” and also has American Depository Shares listed on NASDAQ under code “IXHL”.
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
MELBOURNE, Australia, May 17, 2022 /PRNewswire/ — Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it completed a highly constructive Pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) to discuss the development IHL-42X.
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea (‘OSA’) in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug (‘IND’) application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.
FDA provided guidance on Incannex’s proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies. Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).
In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.
Chief Scientific Officer for Incannex, Dr Mark Bleackley, said: “The FDA’s interest in IHL-42X as a potential therapy for OSA was extremely encouraging. The feedback they provided on the overall proposed development program was positive. The agency’s responses to the specific questions we posed allow us to revise our clinical trial protocols, to ensure that we are running highly efficient studies that generate the type and amount of data the FDA will require in a future marketing application. The results from the pre-IND meeting will shape the IHL-42X development program over the coming months.”
Incannex completed a phase 2 proof of concept clinical trial in 2021 to assess IHL-42X in patients with OSA. Preliminary results from the trial have been published, showing that 60% of trial participants experienced a reduction in apnea-hypopnea index (‘AHI’) of greater than 55% during at least one treatment compared to baseline. 20% of trial participants experienced a reduction in AHI of greater than 80%. The complete clinical study report is anticipated to be released in June 2022.
This announcement has been approved for release to ASX by the Incannex board of directors.About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code “IHL” and also has American Depository Shares listed on NASDAQ under code “IXHL”.
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
MELBOURNE, Australia, May 12, 2022 /PRNewswire/ — Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, advises that it has entered into a Share Sale and Purchase Agreement to acquire 100% of the issued share capital in APIRx Pharmaceuticals USA, LLC (APIRx) (Acquisition).
The stakeholders in APIRx (Sellers) will be issued a total of 218,169,506 new Shares at a value of $0.573 per Share the sale and purchase of APIRx, the price agreed at the signing of the binding terms sheet and announced on March 24, 2022. As a result of the Acquisition, APIRx will become a wholly owned subsidiary of the Company.
Completion of the proposed acquisition is subject to Incannex’s shareholders approving the issue of the new Shares to the Sellers under ASX Listing Rule 7.1 and other customary conditions. The new Shares will be issued to the Sellers at completion of the Acquisition, which is scheduled to occur in June 2022.
The Sellers give warranties and indemnities to IHL that are typical for a transaction of this kind, subject to customary liability qualifications, acknowledgements, and limitations, including in respect of minimum claim amounts, claim time limitations, maximum claim cap, no consequential loss and third-party payment reimbursements. The Sellers provide an indemnification of Incannex for any liability incurred by any APIRx group entity arising in relation to or in connection with the APIRx group entity’s failure to comply with any of its obligations arising under law, equity, or statute in respect of the intellectual property rights in the period before the completion date. The Sellers must also ensure that APIRx carries on its business in the ordinary and normal course ahead of completion.
The Sellers have entered a voluntary escrow deed restricting the disposal of any interest in any of the Shares to be issued (Escrowed Shares). The Escrowed Shares will be escrowed for a period of 12 months from completion of the Acquisition.
CEO and managing director of Incannex, Mr Joel Latham said; “The acquisition of APIRx presents us with clear long and short-term opportunities for significant value growth. Several drug candidates have shortened regulatory pathways to break into areas of patient need representing very large global markets. These candidates are our initial development priority”.
“Incannex’s strong cash position allows us to pursue these near-term product opportunities at the same time as moving at pace to develop the Incannex combination drug candidates. Once the acquisition of APIRx has been finalised, Incannex will have many diverse projects under development, the progress over which we will update the stock exchanges with ongoingly”.
This announcement has been approved for release to ASX by the Incannex board of directors.About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code “IHL” and also has American Depository Shares listed on NASDAQ under code “IXHL”.
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
MELBOURNE, Australia, March 10, 2022 /PRNewswire/ —
Highlights:
20% of trial participants experienced a reduction in AHI of greater than 80% (range: 82.7% to 91.5%) during at least one treatment compared to baseline
60% of trial participants experienced a reduction in AHI of greater than 50% (range: 55.0% to 91.5%) during at least one treatment compared to baseline
Average of low, mid and high-dose IHL-42X reduced AHI in trial participants by 44.4%, compared to baseline
IHL-42X was observed to be well tolerated in the clinical trial
IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life
The Company has been granted a pre-IND meeting with FDA on May 11, 2022 (U.S. EST)
Planning commences for pivotal clinical trials to commence after opening an IND with FDA.
Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced the completion of a preliminary analysis of data from its phase 2, proof-of-concept clinical trial investigating novel cannabinoid combination product, IHL-42X, for the treatment of obstructive sleep apnoea (‘OSA’).
The clinical trial assessed three doses of IHL-42X at reducing the apnoea hypopnoea index (‘AHI’), the main diagnostic and monitoring criteria for OSA, compared to placebo in patients who suffered from the disease. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety. The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital.
A total of eleven participants were recruited to the study and ten participants completed treatment periods. The crossover design of the study permitted Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant serves as their own internal control and inter-participant variation is eliminated. The study included ten placebo treatment periods and twenty-six IHL-42X treatment periods totalling thirty-six AHI data points that were compared to baseline.
Incannex has undertaken preliminary analysis of the study data comparing the AHI during treatment with IHL-42X across all three dose levels or placebo to baseline. At baseline, the average AHI was 42.84. For all IHL-42X treatment periods (using low, mid, and high doses), the average AHI was 23.81, a 44.4 % reduction (p-value 0.0067) compared to baseline AHI. During placebo treatment periods, the average AHI was 40.08, a 6.4 % reduction (p-value 0.75) compared to baseline. 60% of participants experienced a reduction in AHI of greater than 50% (range: 55.0% to 91.5%) and a resulting AHI of less than 20 during at least one treatment period of one dose strength of IHL-42X. 20% of participants experienced a reduction in AHI of greater than 80% (range: 82.7% to 91.5%) relative to baseline during at least one treatment period of one dose strength of IHL-42X.
Specific data from the study, including which IHL-42X doses were received by which patient and when, remain blinded. Patient response to specific IHL-42X doses (low, mid, and high) and the secondary endpoints continue to be analysed by contract research organisation, Novotech, and will only be released to Incannex upon the completion of the analysis as per usual clinical trial processes. This will include a comparison between IHL-42X doses for each patient, which increases the power of the analysis, and provides a more robust differentiation of dose strengths. The full clinical study report is anticipated in Q2 2022.
Preliminary analysis also revealed that IHL-42X was observed to be well tolerated in the clinical trial. All treatment associated adverse events were consistent with what has been reported for constituent components of IHL-42X in historic studies.
Chief Scientific Officer of Incannex Healthcare, Dr. Mark Bleackley, said; “We are delighted that IHL-42X has demonstrated efficacy and good safety characteristics in our preliminary assessment of data from the proof-of-concept trial. The average reduction in AHI calculated across low, mid, and high-dose IHL-42X has met our expectations for what would constitute a valuable product for the treatment of obstructive sleep apnoea. IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life. We look forward to the further analysis of the study data by Novotech, which will include identification of which dose strength performed best.”
As announced on December 20, 2021, Incannex is preparing for a pre-IND meeting with the U.S. Food and Drug Administration (‘FDA’) on the future development plan for IHL-42X. The Company and its medical and scientific advisors have been granted a meeting via teleconference on May 11, 2022 (U.S. EST). This meeting will provide guidance on what data is required to open an Investigational New Drug (IND) application with FDA for IHL-42X for treatment of OSA and the design of a larger pivotal phase 2 clinical trial with trial sites in the United States.
Bonus Entitlement Offer
The Board of Directors has progressed its initiative to offer a bonus option entitlement to both reward shareholders and provide additional funding for the Company in the future. The terms of this entitlement offer will be finalised imminently and announced to ASX.
About Obstructive Sleep Apnoea
OSA is the most common sleep-related breathing disorder, and it causes people to repeatedly stop and start breathing for elongated intervals during sleep. It is a major public health problem and IHL-42X represents a significant commercial opportunity for Incannex as there are no approved pharmacotherapy treatments available to patients at the present time.
OSA is a serious medical condition that increases the risk of numerous health complications1. Drops in blood oxygen levels that occur during OSA increase blood pressure and strain the cardiovascular system. Many people with OSA develop high blood pressure (hypertension), which can increase the risk of heart disease. The more severe the OSA, the greater the risk of coronary artery disease, heart attacks, heart failure and strokes.
People with OSA often have severe daytime drowsiness, fatigue, and irritability due to lack of restorative sleep at night, which are observed causes of workplace accidents. Those diagnosed with OSA are also at higher risk of memory problems, headaches, mood swings and depression.
The current standard of care is a continuous positive airway pressure (‘CPAP’) machine, however, patient compliance to CPAP is low due to discomfort and claustrophobia resulting from pressurized air being pumped into the mouth during sleep. Incannex anticipates greatly improved treatment compliance and outcomes from a pharmaceutical product, which could be IHL-42X subject to further clinical assessment and approval from regulators. Regardless of the discomfort caused by CPAP, the global annual market for OSA detection and treatment using CPAP and other breathing aids is approximately US$10 billion per annum and growing2.
OSA is highly prevalent, affecting approximately 30 million adults in the United States alone. It is estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is approximately US$149.6 billion per annum. These costs include US$86.9 billion in lost productivity, US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents3.
This announcement has been approved for release to ASX by the Incannex board of directors.
About Incannex Healthcare Limited Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners.
Forward-looking statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
MELBOURNE, Australia, March 3, 2022 /PRNewswire/ — Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced it has executed a license agreement with Monash University (‘Monash University’ or ‘Monash’) to develop a novel treatment that combines Virtual Reality (‘VR’) and psychedelics. This marks the initiation of a second clinical psychedelic therapy program.
Incannex has executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment that has been developed by BrainPark, a state-of-the-art clinical research platform at Monash University’s Turner Institute for Brain and Mental Health. The license allows Incannex to investigate the use of the VR therapy tool in combination with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.
The established VR treatment uses an exposure-based approach, providing triggering stimuli in a graded and controlled manner (Exposure and Response Prevention or ERP). Alongside specialised clinical support and the administration of a psychedelic drug, this approach may allow for the development of new skills, changes in mental and biological responses to triggering stimuli, and reductions in pathological symptoms and behaviours.
The associated research and development project will be funded by Incannex and undertaken by Monash, led by Dr Paul Liknaitzky (Head, The Clinical Psychedelic Research Lab, Turner Institute and Department of Psychiatry, Monash) and Professor Murat Yücel (Director, BrainPark, Turner Institute, Monash), in collaboration with Professor Suresh Sundram (Head, Department of Psychiatry, Monash) and Dr Rebecca Segrave (Deputy Director, BrainPark, Monash).
Three license fees are outlined in the agreement and payable upon the decision by Incannex to proceed to subsequent phases of the research program. The parties are working towards a research agreement for the first of these trials, which will assess optimal dose, safety, and tolerability of the combination treatment method. Commercial aspects of the license agreement are detailed in Appendix A.
CEO and Managing Director of Incannex, Mr. Joel Latham, said; “We’re delighted to have commenced this exciting project and to have expanded our partnership with Monash. The combination of psychedelic compounds with an evidence-based VR therapy is a leading edge in the field of mental health treatments. We look forward to providing more detail about the project in due course when clinical trial planning has been finalised.”
About Incannex Healthcare Limited Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of generalised anxiety disorder (GAD), obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Website: www.incannex.com.au Investors: investors@incannex.com.au
Forward-looking statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
Appendix A
Licence Fees and Royalties
The grant of the license is conditional on the payment of licence fees and royalties that Incannex will pay to Monash as follows:
A$300,000 on execution of the license agreement,
A$250,000 on execution of a research agreement between Incannex and Monash concerning a second clinical trial,
A$250,000 on execution of a research agreement between Incannex and Monash concerning a third clinical trial, and
a royalty of 7.5% of net sales, subject to successful commercialisation of a therapy.
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