Terran Biosciences Receives Notice of Allowance for Four US Patents Including for the World’s First New Salts and Polymorphs of Psilocybin, potentially enabling future 505(b)(2) pathway

MIAMI--(BUSINESS WIRE)-- Terran Biosciences, Inc. (“Terran”), a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has received notice of allowance from the United States Patent and Trademark Office (USPTO) for four US patents covering a number of breakthroughs in the psychedelic therapeutic space.

Two of these patents cover the world’s first new forms of psilocybin (psilocybin HCl and psilocybin edisylate) and their method of use in treating neurological and psychiatric disorders, including depression. The clinical trials of psilocybin to date have been limited to using the older forms of zwitterionic psilocybin described in the historical literature.

Terran plans to use its new forms of psilocybin to pursue a rapid 505(b)(2) FDA approval pathway if one of the existing forms of psilocybin currently in clinical trials is approved. This regulatory pathway could potentially enable Terran to use pharmacokinetic bridging studies and leverage existing safety and efficacy data from completed trials to bring a Terran psilocybin product to market approximately five years after the first psilocybin approval.

“With these allowances of our novel forms of psilocybin, and GMP manufacturing already completed, Terran is moving quickly toward the goal of providing patients with affordable and accessible psilocybin treatment options,” said Dr. Sam Clark, Terran’s founder and CEO. “Additionally, with the allowance of our breakthroughs in the chemistry of DMT and 5-MeO-DMT, we hope to deliver oral versions of these therapeutics, which we believe will provide the best use profile for patients.”

Terran also received a notice of allowance for a patent covering the world’s first orally active prodrugs of DMT and 5-MeO-DMT. DMT is a psychedelic compound that is not orally active unless taken in combination with a monoamine oxidase inhibitor (MAOI) to help reduce metabolic breakdown. However, this combination approach is difficult to translate to widespread clinical use as it can be associated with side effects such as nausea, vomiting, and changes in blood pressure [1,2]. Terran’s new patent-protected prodrugs were designed to avoid this metabolic breakdown and to be given as a single oral dose without the need for combination with an MAOI.

Terran plans to leverage the 505(b)(2) pathway to bring an oral DMT product and an oral 5-MeO-DMT product to the market after the FDA approval of an alternative form of the historical compound (e.g., injectable, inhaled, or buccal forms), which are in trials now.

Additionally, Terran is developing ibogaine derivatives and has received a notice of allowance on a novel form of tabernanthalog monofumarate and the method of use for treating neurological and psychiatric disorders. Terran believes this new discovery may be the most stable form of tabernanthalog monofumarate.

ABOUT TERRAN BIOSCIENCES

Terran Biosciences is a biotech platform company developing a portfolio of therapeutics and technologies for patients with neurological and psychiatric diseases. Terran has built a CNS-focused, tech-enabled drug development platform and is rapidly advancing a number of assets that include a late-stage therapeutic for schizophrenia, an FDA-cleared neuroimaging software platform, and a drug design engine that has generated first-in-class and best-in-class psychedelic-based therapeutics. Follow us on LinkedIn and X.

Citations

1. Sjöqvist F. Psychotropic drugs (2). Interaction between monoamine oxidase (MAO) inhibitors and other substances. Proc R Soc Med. 1965 Nov;58(11 Part 2):967-78. PMID: 4952963; PMCID: PMC1898666.
2. Bouso JC, Andión Ó, Sarris JJ, et al. Adverse effects of ayahuasca: Results from the Global Ayahuasca Survey. PLOS Glob Public Health. 2022;2(11):e0000438. Published 2022 Nov 16. doi:10.1371/journal.pgph.0000438

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