Nova Mentis Earns Psilocybin Orphan Drug Designation in Europe for Fragile X Syndrome
Nova Mentis Life Science Corp. (NMLSF) announced it received orphan drug designation from the European Medicines Agency for its psilocybin drug targeting fragile X syndrome (FXS), a leading genetic cause of autism spectrum disorder. This designation accelerates the drug approval process, providing benefits like ten years of market exclusivity and grants. CEO Will Rascan emphasized the milestone's significance for advancing clinical programs in Europe, aiming for a phase 2 study. Currently, there are no effective treatments for FXS, making this development a critical step toward addressing an unmet medical need.
- Received orphan drug designation from EMA for psilocybin drug targeting FXS.
- Provides ten years of market exclusivity upon approval.
- Access to reduced fees and potential grants for the drug's development.
- Plans to initiate a phase 2 study in Europe.
- None.
VANCOUVER, BC, Oct. 26, 2021 /PRNewswire/ - 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 received orphan drug designation from the European Medicines Agency (EMA) for its propriety psilocybin drug for the treatment of fragile X syndrome (FXS), the leading genetic cause of symptoms related to autism spectrum disorder (ASD).
"Orphan Drug designation of our proprietary psilocybin formulation in Europe is a significant milestone on the pathway to drug approval," says Will Rascan, NOVA's CEO & President. "This achievement has the potential to rapidly advance our company's clinical program in Europe with the goal of approval of psilocybin in the treatment of FXS, a major unmet medical need. Nova intends to move expeditiously to begin a phase 2 study with psilocybin in FXS." Medicines that have been granted an orphan designation receive the following benefits:
- Ten years of market exclusivity: once approved, NOVA's proprietary formulation is protected from competition with similar medicines in similar indications.
- Reduced fees for protocol assistance and other regulatory activities.
- Access to grants from the European Commission and other sources.
- Scientific advice and administrative and procedural assistance.
- Access to a centralized marketing authorization with a single application.
There are currently no approved prevention or treatment methods for FXS. Current therapies, including pharmaceutical and behavioural interventions, offer a patchwork of solutions that have limited efficacy and high toxicity. Psilocybin has the capacity to influence cognition and behaviour as well as modulate the immune system and neural signaling pathways. Likewise, psilocybin is non-toxic and is not expected to have adverse side effects in humans.
"Our proprietary psilocybin drug is being proposed as a novel, first-in-class treatment for fragile X," stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. We have achieved several drug development breakthroughs this year, including a significant therapeutic effect in validated preclinical models of ASD and FXS, identification of an effective dose and no observed psilocybin toxicity. We look forward to working closely with EMA to advance our efforts to receive European regulatory marketing approval for our leading psilocybin drug candidate."
EMA is a decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Orphan designation is a status assigned to a medicine intended for use against a rare condition.
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).
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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SOURCE Nova Mentis Life Science Corp.
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