Nova Mentis files orphan drug designation against fragile X with the European Medicines Agency
VANCOUVER, BC, August 12, 2021 / CNW / – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and world leader in first-class psilocybin-based therapies and complementary diagnostics for neuro-inflammatory disorders, is pleased to announce that it has filed an orphan drug designation application with the Agency European Medicines Agency (EMA) for its proprietary psilocybin-based medicine to help treat patients with fragile X syndrome (FXS), the leading genetic cause of symptoms related to autism spectrum disorders (ASD).
“NOVA continues to advance our drug research and development program to explore the clinical potential of psilocybin for chronic neuro-inflammatory diseases with unmet medical needs,” said Rascan, CEO and President of NOVA. “Orphan drug designation would provide our company with a wide range of incentives, including support for trial protocols, reduced regulatory fees and 10 years of market exclusivity after drug approval. ”
NOVA’s R&D plan for the successful regulatory approval and commercial launch of psilocybin in TSA and FXS follows standard drug development procedures used by established pharmaceutical companies. Our proprietary manufacturing process will deliver> 98% cGMP Psilocybin – repeatedly and consistently. The Company is setting up a database of biological markers associated with ASD and FXS, which will complement behavioral results, improve the identification of specific disease subsets and facilitate the development of patient-specific treatments. In the immediate future, NOVA plans to submit regulatory documents to the FDA and EMA that support the potential therapeutic efficacy of psilocybin. These will include statistical analyzes of baseline observational data and disease outcome biomarkers, including the neurotransmitter serotonin and other physiologically active biomarkers involved in the development of ASD and FXS. Finally, NOVA will conduct clinical trials to assess how patients with ASD and FXS can benefit from treatment with psilocybin. These trials will be designed according to ethical principles and anchored in the knowledge acquired through our non-interventional studies and our new panels of biomarkers.
“NOVA’s lead drug candidate, psilocybin (NM1010), in a preclinical model of FXS, showed positive improvement in cognition with no apparent psychedelic side effects,” said Dr. Marvin S. Hausman MD, Chairman of the Scientific Advisory Board of NOVA. “I am also delighted to report that animals treated with psilocybin showed changes in inflammatory biomarkers potentially involved in the ASD disease process.”
FXS is a genetic neurological disorder in which the reduction / absence of the FMR1 protein (FMRP) results in dysfunction of neural signaling and behavioral abnormalities. The total number of patients in the European Union (EU) has been estimated at around 88,000 for an overall prevalence of 2 in 10,000, which is below the ceiling for orphan designation of 5 in 10,000.
There is currently no approved prevention or treatment method, although psychiatric approaches to autism spectrum disorders have been used in FXS with some success. Currently available therapies for FXS – including pharmaceutical and behavioral interventions – fail to address the emotional aspects of the disorder, offering a patchwork of solutions that have limited efficacy and high toxicity.
Psilocybin is offered as a new first-class treatment for FXS. Beyond the promising cognitive benefits, psilocybin also has peripheral effects, including the ability to curb inflammation and modulate the microbiota. Given the high prevalence of gastrointestinal disturbances in FXS, psilocybin and other tryptamine derivatives may provide additional benefit in the gut. Psilocybin is expected to modulate the molecular and behavioral foundations of FXS, including improvements in brain plasticity and reduced anxiety and behavioral rigidity – a significant step above currently available methodologies.
EMA is a decentralized EU agency responsible for the scientific evaluation, supervision and control of the safety of medicines in the EU. The orphan designation is a status assigned to a drug intended for use against a rare disease. The prevalence of the disease in the EU must not exceed 5 in 10,000 and the medicine must meet certain criteria.
About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canada-based biotechnology company and a world leader in the development of psilocybin-based diagnostics and therapies for neuro-inflammatory 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
Rascan, President and CEO
Nova Mentis Life Science Corp.
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