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Wesana Health Outlines Accelerated Drug Development Pathway

Wesana Health Outlines Accelerated Drug Development Pathway

CHICAGO and TORONTO, May 10, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, is pleased to announce that following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration (“FDA”), the Company is expanding its lead indication for SANA-013 to Major Depressive Disorder (“MDD”) and exploring other complementary orphan indications.

Consistent with the positive feedback received from FDA, Wesana will accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in H1 2023. In contrast to the prior development pathway for SANA-013 with TBI associated depression as the lead indication, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study.

Wesana’s SANA-013 is designed to deliver a novel depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a non-hallucinogenic dose of psilocybin combined with cannabidiol (CBD). The low, non-hallucinogenic dose of psilocybin in combination with CBD is being developed for MDD and other indications so that affected people can benefit from a chronic, at-home use proposition.

Daniel Carcillo, Wesana’s founder and Chief Executive Officer, said, “Given the positive written feedback from FDA regarding SANA-013, we are extremely excited to begin developing meaningful clinical data for our novel formulation and protocol. We believe SANA-013 provides Wesana distinct advantages compared to other companies exploring psilocybin, as they are primarily focused on delivering large in-clinic doses of psilocybin on an intermittent basis and therefore are not optimally positioned to treat conditions such as MDD that likely will require some kind of chronic dosing.”

MDD is a chronic, recurring, and debilitating mental disorder leading it to be one of the most burdensome illnesses on a global scale. Patients suffering from MDD are frequently and significantly impaired from an occupational and social function standpoint resulting in severe economic costs. With approximately 264 million people suffering from depression globally, according to World Health Organization data in 2020, the market size is currently estimated to grow at a CAGR of 3.9% to US$16 billion by 2026.1

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: (773) 236-7972

Investor Relations:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 702-329-8038

Media Contacts:
Isadora Forman
Email: media@wesanahealth.com
Phone: 917-653-4613

Cautionary Note Regarding Forward-Looking Information

This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the Company’s future operations and clinical trials, including initiation of a Phase 1b/2a study for MDD in H1 2023. as part of a revised accelerated development pathway; and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.

Certain assumptions that influence the successful initiation of a Phase 1b/2a study for MDD in H1 2023 as part of an expanded development pathway include: (i) the Company’s capital will be sufficient to execute the expanded (or any) development pathway; (ii) the broadened indication and the future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise resulted from the broadened indication; and (v) additional pre-clinical studies required for MDD will be commenced and completed on a timely basis and results will be supportive and as anticipated.

Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to there being no assurance as to the Company’s ability to continue as a going concern; there being no assurance as to the Company’s ability to raise additional funding to finance its operations; the detrimental impact of future losses and negative cash flow from operations; requirements for additional capital; lack of product or service revenue; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; competition from other biotechnology and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic inspired drugs possibly never being approved as medicines; regulatory or political change; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; requirements of commercial scale and quality manufactured drug supply; negative results from pre-clinical and clinical trials or studies of others; unfavourable publicity or consumer perception; not achieving publicly announced milestones; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; general economic, market and business conditions and other risk factors including those found in the Company’s management’s discussion and analysis for the year ended December 31, 2021 and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.

Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

1 Source: 2020, October. “Depression Treatment Market By Drug Type (Antidepressants, Antipsychotics) By Application (Major Depressive Disorder (MDD), Bipolar Disorder), By End-User (Hospitals, NGOs, Mental Health Centers), By Distribution Channel, and By Region, Forecasts to 2027.” Emergen Research,
https://www.emergenresearch.com/industry-report/depression-treatment-market

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Source: Wesana Health

Released May 10, 2022

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Treating rare disorders with ketamine

PharmaTher Granted FDA Orphan Drug Designation for Ketamine to Treat Status Epilepticus

PharmaTher (PHRM) is developing a treatment for a rare, seizure-inducing disorder called Status Epilepticus using ketamine. This week, it was granted a designation that will save them millions of dollars in the process. 

It’s called an Orphan Drug Designation and it gives the company potential tax credits, grant eligibility, and marketing exclusivity, and waives a $2.4M New Drug Application fee. It’s designed to incentivize R&D of treatments for rare conditions.

PharmaTher previously received the designation for ketamine to treat ALS and complex regional pain syndrome too!

PharmaTher Inc.

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Slowing the progression of ALS

PharmaTher Announces FDA Approval of Investigational New Drug (IND) Application for Ketamine to Treat ALS

When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found. 

Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.

In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease. 

The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.

PharmaTher Inc.

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PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher (PHRM) applied for an orphan drug designation for a ketamine treatment for a rare seizure condition called Status Epilepticus. If approved, the designation would give the company potential tax credits, grant eligibility, and exclusive marketing rights.

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PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

  • Adds to PharmaTher’s existing FDA orphan drug portfolio with amyotrophic lateral sclerosis and complex regional pain syndrome
  • Strengthens commitment to treat rare disorders and life-threatening conditions with ketamine
TORONTO, November 24, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has applied with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat Status Epilepticus (“SE”), a rare neurological disorder requiring emergency treatment for a seizure.  The Company has received FDA ODD for ketamine to treat amyotrophic lateral sclerosis (“ALS”) and complex regional pain syndrome (“CRPS”).  The addition of SE strengthens the Company’s pharmaceutical strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions.

SE is a life-threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies found an annual incidence of SE ranging from 41/100,000-61/100,000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000-180,000 episodes of convulsive SE each year in the U.S. SE affects individuals of all ages and it complicates various neurological and systemic illnesses. If SE is not treated immediately, permanent neuronal damage may occur, contributing to high morbidity and mortality rates. The mortality associated with SE is estimated at 17% and may lead to morbidity, including cognitive defects and neurological injury. SE is initially treated with benzodiazepines, which approximately 35-45% of patients are refractory to benzodiazepines.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Ketamine has the potential to treat various mental health, neurological and pain disorders, and we are focused on expanding ketamine’s therapeutic utility in rare disorders and life-threatening conditions including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, and now status epilepticus.  The FDA orphan drug application for ketamine to treat status epilepticus builds on our belief in the potential of ketamine to improve quality of life and to save lives.”

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify ketamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.

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 business development opportunities or 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.

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U.S. FDA Approves Nova Mentis Orphan Drug Application

U.S. FDA Approves Nova Mentis Orphan Drug Application

Psilocybin Fragile X Syndrome Treatment

Vancouver, British Columbia – November 2, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce that the U.S. FDA has approved the Company’s proprietary psilocybin drug Orphan Drug Application to  treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).

“NOVA has established a unique position in the field of psychedelic therapy by having its FXS program achieve orphan drug status in both the United States and European Union,”says Will Rascan, NOVA’s CEO & President. “I am pleased to announce that we are the first biotech company to have psilocybin registered for treatment of FXS in the drug regulatory logs of both the FDA and EMA.”

Medicines that have been granted an orphan designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) receive  benefits, including but not limited to:

  • Seven-Ten years of market exclusivity: FDA and EMA cannot approve the same drug for the same indication.
  • 25% federal tax credit for expenses incurred in conducting clinical research within the United States.
  • Waiver of Prescription Drug User Fee Act (PDUFA) fees: a value of approximately $2.9 million.
  • Ability to qualify to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies.
  • Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.

“The attainment of Orphan Drug status in both the U.S. and Europe is a significant milestone towards launch of psilocybin FXS phase 2 clinical studies,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The U.S. FDA has issued guidance concerning the usage of observational clinical study Real-World Evidence (RWE) to support the potential benefits of a medical product (1).  NOVA intends to immediately launch an IRB approved ASD observational study to provide baseline clinical biomarker RWE data in support of its psilocybin IND to treat FXS.”

  1. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

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PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

  • Achieving its second FDA orphan drug designation with ketamine.
  • Building a proprietary ketamine-based product pipeline for rare and near-rare disorders in pain and inflammation.
  • Seeking to enter Phase 2 clinical trial in 2022.

TORONTO, October 13, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for ketamine in the treatment of complex regional pain syndrome (CRPS), a rare chronic pain and inflammatory condition following an injury to a limb (arm, leg, hand or foot).  This follows the FDA ODD grant of ketamine for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, announced by the Company on August 4, 2021.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Receiving our second FDA orphan drug designation with ketamine for CRPS continues our momentum in building a specialty ketamine-based product pipeline for not only mental health disorders, but also for rare and near-rare conditions present in neurological (Parkinson’s disease, ALS), pain and inflammatory disorders.  We expect to pursue a Phase 2 clinical study using our proprietary cGMP ketamine product in 2022 for CRPS.”

CRPS is a debilitating condition characterized by severe, continuous, burning or throbbing pain in a limb.  CRPS is known as one of the most painful disorders and the risk of suicide is significantly higher in patients with CRPS with one study demonstrating that 75% of patients had a high risk for suicide (Lee et al., Psychiatry Investig 2014;11(1):32-8).  CRPS has acute (recent, short-term) and chronic (lasting greater than six months) forms of excessive pain accompanied by changes in skin color, temperature and/or swelling, which results in loss of physical function and can lead to significant and sometimes permanent disability.  CRPS can occur after surgery or trauma, including brain or spinal cord injury.  There is currently no medication approved for the treatment of CRPS.

Ketamine acts as a noncompetitive, NMDA channel blocker that can prevent the induction of synaptic potentiation.  NMDA receptors play a central role in the processes of induction and maintenance of pain sensitization, accounting for the analgesic efficacy of ketamine.  Although ketamine has actions at other relevant sites, including nicotinic and opioid receptors, as well as, via monoamine reuptake transporters, it is likely that both the anesthetic and the analgesic actions of ketamine are largely mediated by NMDA receptor antagonism.  Likewise, the psychotropic and sympatho-excitatory side effects of ketamine are also predominantly mediated through NMDA receptor blockade.

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify a drug for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.

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 initiating 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.
​
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 May 31, 2021 (“MD&A”), dated September 7, 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.

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Nova Mentis Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

Nova Mentis Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

Vancouver, British Columbia – September 14, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration (FDA) to receive orphan drug designation for its proprietary psilocybin drug to  treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).

The U.S. Orphan Drug Act (ODA) grants special status to a drug for the treatment, diagnosis or prevention of a rare disease or condition. In the United States, a rare disease is defined as a condition that affects fewer than 200,000 people. Developmental delays affect ~13% of all American children ages 3-10 and FXS is the most common inherited cause of intellectual disability. The Centers for Disease Control and Prevention estimates FXS prevalence as 1 in 4,000 for males and 1 in 8,000 for females.

“NOVA is committed to accelerating the research and development of psilocybin-based therapeutics to help treat fragile X syndrome,” says Will Rascan, NOVA’s CEO & President. “With FDA orphan drug designation, our Company would qualify for benefits and incentives such as seven years of market exclusivity after drug approval, tax credits for clinical testing, eligibility for orphan drug grants and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.” He adds the Company filed for orphan drug designation with the European Medicines Agency (EMA) on August 12, 2021.

“New clinical treatments for FXS are needed and we believe serotonergic agonists like psilocybin represent  a promising option,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “Psilocybin and other tryptamine derivatives are expected to modulate the molecular and behavioural underpinnings of the disorder, improve brain plasticity, improve cognition, reduce anxiety and behavioural rigidity. NOVA has successfully completed three preclinical studies confirming therapeutic efficacy, without apparent side effects, of Nova’s proprietary psilocybin drug. Moreover, an important catalyst driving the fragile X clinical program is the ability of our drug to modulate levels of neuroinflammatory molecules (cytokines) measured pre- and post-treatment.”

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

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Taking the trip out of psilocybin

Nova Mentis Files Fragile X Orphan Drug Designation with European Medicines Agency

Fragile x syndrome (FXS) is the leading genetic cause of autism spectrum disorder (ASD) symptoms, yet there is currently no approved prevention or treatment options. Nova Mentis (NOVA) is working to fill this gap with a non-psychedelic psilocybin-based drug.

The company announced that its proprietary psilocybin drug, NM1010, was able to improve cognition without a creating psychedelic effect in a preclinical model of FXS. In tests on animals, the drug showed improvements in inflammatory biomarkers that may be linked to the ASD disease process.

The company has filed for orphan drug designation with the European Medicines Agency (EMA), a status that gives companies exclusive rights and tax credits to incentive the development of treatments for diseases affecting ≤ 5 in 10,000 people.