Delix Therapeutics, a private Boston-based company, is partnering with The National Institute on Drug Abuse (NIDA) to develop a treatment for substance abuse. The partnership will evaluate Delix’s non-hallucinogenic formulation of ibogaine, which has already shown promise of reducing alcohol- and heroin-seeking behavior.
Marcus Capone, a former Navy SEAL who was battling PTSD, finally got his life back after travelling to Mexico for an ibogaine treatment.
He instantly felt like a huge weight had been lifted, as if his brain “was rebooted like a new operating system.”
“You can’t hide from the medicine. It’s going to reach down and it’s going to pull out everything that is affecting you,” he explains.
VANCOUVER, BC, Nov. 4, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, is pleased to provide an operational progress update on the strategic initiatives of its operating segments – MINDCURE Research and MINDCURE Technology.
Synthetic Ibogaine Production Update
In March 2021, MINDCURE announced the initiation of chemical synthesis routes for the production of fully synthetic ibogaine. In July 2021, the Company applied for patents on two routes to full chemical synthesis and initiated the production of Good Laboratory Practice (“GLP”) ibogaine leading to the production of Good Manufacturing Practice (“GMP”) ibogaine in order to scale and manufacture a global supply of fully synthetic ibogaine. MINDCURE is currently on schedule and expects to have GLP supply available for research partners beginning in Q2 of 2022.
Pre-Clinical Update
MINDCURE confirms that it is preparing to ship ibogaine drug material to its pre-clinical research partner. The material will initially be used for broad cardiac and neurologic screens, with the potential to conduct in-depth behavioral studies. This program has been identified as MSYNTH-001, and the Company expects results from the first studies during the first quarter of 2022.
In addition to advancing the scale of its synthetic ibogaine program, MINDCURE continues to explore options for drug pipeline expansion. Two candidate selection programs are currently underway, known internally as MC-106 and MC-808. The Company will provide further information on these programs in the second quarter of 2022.
Clinical Trial Update
MINDCURE has completed its draft research protocol for the use of MDMA and psychotherapy to treat female sexual hypoactive desire disorder, known as The Desire Project. The Company expects a pre-IND meeting with the FDA to be scheduled in the first quarter of 2022 and for its Phase 2 trial to begin by the third quarter of 2022. Further, site initiation and initial screening are planned for March 2022, with recruitment and enrollment to follow.
“We are proud to report that MINDCURE’s core research programs are progressing rapidly, showcasing our disciplined commitment to advancing MINDCURE’s drug research and commercial production programs. Concurrently, we maintain a focus on identifying opportunities to expand our drug development pipeline,” said Kelsey Ramsden, President & Chief Executive Officer of MINDCURE.
Digital Platform iSTRYM Update
The Company released the minimum viable product (“MVP”) of its digital therapeutics (DTx) technology, iSTRYM, into partner clinics across North America in August. MINDCURE is pleased to announce that it has exceeded its previously announced target and timeline of 10 clinics by the end of 2021. The Company has already partnered with 20 ketamine clinics in nine states in the US and three provinces in Canada and plans to expand to the broader mental health market in 2022.
In addition, MINDCURE will begin full commercial deployment to all partner clinics in early 2022, with expansion plans to the UK and Europe by the fourth quarter of 2022.
In addition to its recently announced letter of intent with Awakn Life Sciences Corp. to distribute their Ketamine for Alcohol Use Disorder (“AUD”) protocol in North America via iSTRYM, MINDCURE will expand its selection of existing ketamine protocols with an additional MINDCURE developed protocol in the first quarter of 2022. The Company is continuing on its path toward becoming a leader in the distribution of best-in-class therapy protocols for both partners and providers.
Observational Study Update
MINDCURE is pleased to announce that its Integration Protocol Research Study is complete. As previously announced in March 2021, unconditional ethics approval from Veritas IRB was received for the study. The data has been amassed and findings incorporated into the MVP of iSTRYM. As a next step, the Company’s research partners will submit findings for publication. Understanding integration protocols and practices is an important part of providing best-in-class care specific to psychedelic medicines in practice.
Corporate Update
MINDCURE has further engaged Sandstone Media LLC (“Sandstone”) to provide a broad range of product and brand awareness, marketing and media services, including message development, content creation, social media, advertising, marketing and retargeting, which may include related investor relations services. Sandstone will be paid up to USD$375,000 for the execution and management of the campaign.
Lastly, the Company has granted a total of 30,000 stock options to certain employees pursuant to the terms of the Company’s long term incentive plan (“Plan”). The stock options are exercisable at a price of $0.33 per share and subject to the terms of the Plan.
About MINDCURE
Mind Cure Health (“MINDCURE”) is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally. Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.
On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Phone: 1-888-593-8995
Forward-Looking Information
Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases.
Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; the Company will develop its products as expected and that they will attain the outcomes anticipated; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that strategic partnerships entered by the Company will create the opportunities and outcomes anticipated; that MINDCURE will advance wellness worldwide; that trading on the OTCQX will attract additional investment and provide additional liquidity for shareholders.
Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results and involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: successful clinical studies relating to ibogaine and the Desire Project, successfully synthesizing and manufacturing of ibogaine, the successful development, integration and deployment of iSTRYM, the successful development of appropriate Ketamine protocols, and acquiring adequate protection of any IP developed. Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.
Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.
For further information
MINDCURE Investor Relations
1-888-593-8995
Media Inquiries
Annie Graf / Kristin Cwalinski
KCSA Strategic Communications
The Company has research collaborations with the Terasaki Institute to evaluate MicoDose-MN™; a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin, MDMA, LSD and DMT, and with The Queen’s University of Belfast (“QUB”) to evaluate MacroDose-MN™; a patented hydrogel-forming microneedle patch, to deliver ketamine and PharmaTher’s proprietary ketamine combination formulation, ketamine and betaine (“KETABET™”) for mental health, neurological and pain disorders.
Research results with MicroDose-MN™ for psilocybin and LSD will be made available in November 2021, followed by results with MDMA and DMT in December 2021. Research results with MacroDose-MN™ for ketamine and KETABET™ will be made available in December 2021. Current research results are very encouraging; therefore, the Company has decided to expand research to include ibogaine and mescaline, prepare IND applications with the FDA for Phase 1 and 2 clinical studies in Q2-2022, and discuss partnership opportunities with specialty pharmaceutical companies seeking a novel and validated delivery system for psychedelics targeting specific indications and desired pharmacokinetic profiles.
PharmaTher is proceeding with its IND-enabling studies and manufacturing scale-up for cGMP microneedle patches for its expected clinical studies in 2022. The MicroDose-MN™ and MacroDose-MN™ patches can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems. In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
“We are nearing completion of our research programs in validating the utility of our microneedle patch delivery technologies for psychedelics, derisking our plans in advancing the completion of our IND-enabling studies to support future clinical studies and partnering opportunities,” said Fabio Chianelli, CEO of PharmaTher. “As we look forward to announcing our research results, our focus continues to expand our ketamine-based product pipeline and advance our microneedle patch programs to unlock significant value and return on investment for long-term revenue potential through our products and our future partners.”
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
The US government is funding psychedelic research to get military members the relief they deserve!
A new measure, filed by Rep. Dan Crenshaw of Texas, would allow the Secretary of Defense to award research grants to study psychedelic therapy as a PTSD treatment for active military members.
The measure would allow any State or Federal agency, academic institution, or nonprofit to study the therapeutic effects of psilocybin, ibogaine, MDMA, or 5-MeO-DMT. If passed, funds could be used for Phase 2 clinical studies involving members of the Armed Forces or to train practitioners to offer the treatment.
NEW YORK, Sept. 21, 2021 (GLOBE NEWSWIRE) — DemeRx IB, Inc. (“DemeRx”), an atai Life Sciences (Nasdaq: ATAI) (“atai”) platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), today announced that the first subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002). The trial has commenced enrollment and dosing of recreational drug users and healthy volunteers in the Phase 1 segment of the study at the Manchester clinical unit of MAC Clinical Research (MAC) in the UK, one of Europe’s largest clinical development organizations.
DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.
The Phase 1/2a trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder. We expect to obtain safety data from the phase 1 segment of this trial in early 2022.
“By launching the Phase1/2a trial, we look forward to bringing important data from carefully designed, controlled studies to the existing literature on ibogaine, a compound with substantial history,” said Dr. Deborah Mash, CEO and President of DemeRx. “We are hopeful that this early trial can begin to establish a safe and efficacious profile for Ibogaine, so that we can potentially offer a new option for patients seeking to break free from OUD who have far too few options.”
“The opioid crisis has ravaged the U.S. for over 20 years with little sign of letting up. The COVID-19 pandemic revealed the tragic vulnerability of people addicted to drugs as the CDC tallied 93,000 drug overdose deaths in 2020, a 30% increase, 70,000 of which involved opioids,” added Srinivas Rao, Chief Scientific Officer and Co-founder of atai Life Sciences. “Launching our Phase 1/2a trial of ibogaine with assent of regulators, we believe is a major step towards reversing the trend of the opioid crisis.”
“We strive for bold innovation to address the global crisis of mental health,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences. “By launching this Phase 1/2a trial, we are grateful for the work of our dedicated teams at DemeRx and atai who are committed to this ethos, striving to bring transformative treatments through rigorous testing.”
About DemeRx, Inc. & DMX-1002
DemeRx, Inc. is a Miami-based clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of OUD. DemeRx’s mission is to advance the development of potential treatments for OUD in order to prevent patient suffering, provide better treatment retention, and decrease illegal opioid use.
DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002 is a GMP drug product manufactured for human use.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the initiation of the Phase 1/2a clinical trial of ibogaine HCl and future activities thereunder, the potential of DMX-1002, and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.
Contact Information
For atai:
Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life
Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com
For DemeRx:
Company Contacts:
Deborah C Mash PhD
CEO & Founder, DemeRx Inc.
Phone: +1(305)753-2175
Email: dmash@demerx.com
Matthias Luz MD
Executive Vice President & Chief Medical Officer
Email: mluz@demerx.com
