Terran Biosciences discovers what may be the first new salts, co-crystals, and polymorphs of psilocybin in history, publishes PCT patent application, and files psilocybin Drug Master File (DMF) with FDA

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Psilocybin is one of the main active compounds in psychedelic mushrooms and has been used by humans for thousands of years.

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PR Newswire

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Friday, May 19, 2023

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Psilocybin, GMP, Human, Drug Master File, Depression, Therapy, SOLID, History, PCT, Literature, Hydrogen chloride, Patent, Patient, DMF, Ecosystem, Salt, FDA, Terran, SALTS, Pharmaceutical industry

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NEW YORK, US

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TERRAN BIOSCIENCES, TERRAN BIOSCIENCES, INC.

Summary

Key Points:

Psilocybin is one of the main active compounds in psychedelic mushrooms and has been used by humans for thousands of years.
Recent clinical studies suggest psilocybin is efficacious in treating depression.
According to the literature, there are three main polymorphic forms of zwitterionic psilocybin: form A, form B, and form A' (A-Prime).
Terran also replicated this comprehensive set of studies with the psilocin prodrug O-acetylpsilocin, resulting in additional novel salts and polymorphs of that compound as well.

Terran Biosciences discovers what may be the first new salts, co-crystals, and polymorphs of psilocybin in history, publishes PCT patent application, and files psilocybin Drug Master File (DMF) with FDA

NEW YORK, May 19, 2023 /PRNewswire/ -- Terran Biosciences ("Terran"), a biotech platform company dedicated to the development of transformational therapeutics for neurological and psychiatric diseases, has announced the publication of a PCT patent application covering what may be the first new salts, co-crystals, and polymorphs of psilocybin in history.

Psilocybin is one of the main active compounds in psychedelic mushrooms and has been used by humans for thousands of years. Recent clinical studies suggest psilocybin is efficacious in treating depression.

Until now, the psilocybin molecule has existed as a zwitterion, which was long thought to lack the ability to form salts, and so many experts believed that additional forms of psilocybin would not be possible. According to the literature, there are three main polymorphic forms of zwitterionic psilocybin: form A, form B, and form A' (A-Prime). However, Terran recognized that having access to additional forms of psilocybin would likely remove potential barriers to development across the ecosystem, enable the development of new formulations, provide expanded options to researchers, and accelerate the timeline of bringing this important compound to patients.

To this end, Terran's solid-state chemistry experts performed one of the most rigorous evaluations of psilocybin to date and were successful in creating a number of novel salt forms of psilocybin. These salts then underwent extensive polymorph screening until the most stable polymorphs were determined. Terran believes that these compounds may represent the first new salts and polymorphs of psilocybin in history, including forms such as psilocybin HCl forms A, B, and C, psilocybin HCl co-crystal form A, psilocybin edisylate forms A and B, and psilocybin mesylate form A. Terran believes this breakthrough could fundamentally change the development landscape for psilocybin and allow the widespread development and commercialization of these new forms of psilocybin.

Terran also replicated this comprehensive set of studies with the psilocin prodrug O-acetylpsilocin, resulting in additional novel salts and polymorphs of that compound as well. A full description of this groundbreaking work is detailed in the PCT application "PSILOCYBIN AND O-ACETYLPSILOCIN, SALTS AND SOLID STATE FORMS THEREOF" (WO2023086962)

Terran is currently producing GMP psilocybin and supplying researchers and clinics worldwide. Terran has also filed a Drug Master File (DMF) with the FDA, marking Terran's commitment to become one of the preeminent suppliers of psilocybin to researchers and clinical sites in the US and worldwide.

Dr. Sam Clark, Terran's CEO commented, "We're really excited about this discovery and believe that these new forms of psilocybin will significantly broaden access and improve the ability of researchers and developers to work with this compound to deliver new therapeutics. We believe this also marks a new chapter in psychedelic medicinal chemistry, in which we have worked with one of the most well-studied compounds to create novel breakthroughs previously not thought possible."

About Terran Biosciences, Inc.

Terran is a biotech platform company developing a portfolio of therapeutics and technologies for patients with neurological and psychiatric diseases. Backed by a number of life-science and tech investors, Terran has built a CNS-focused, tech-enabled drug development platform, and is rapidly advancing of number of late-stage assets, which include novel psychedelic-based therapeutics.

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SOURCE Terran Biosciences, Inc.