Patents issued for ‘world’s first’ psilocybin salts, polymorphs

Key takeaways:

• Terran Biosciences was issued patents for four patents in psychedelic treatments.
• Patents were issued for the first orally active prodrugs of DMT and 5-MeO-DMT.

The U.S. has issued patents covering several advances in psychedelic therapy, including the “world’s first” new forms of psilocybin and orally active DMT and 5-MeO-DMT, according to a press release from the manufacturer.

“Terran is moving quickly toward the goal of providing patients with affordable and accessible psilocybin treatment options,” Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, a biotech firm that develops therapeutics for patients with neuropsychiatric illnesses, said in the release. “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 was issued patents covering the first salts and polymorphs of psilocybin, psilocybin HCl and psilocybin edisylate, for treatment of depression and other neurological and psychiatric disorders. If one of the older forms of psilocybin now under clinical trial is approved, Terran plans to bring its own product to market about 5 years later via the FDA’s 505(b)(2) approval pathway.

A patent was also issued for what Terran called the first orally active prodrugs of DMT and 5-MeO-DMT. The prodrugs are designed not to require combination with a monoamine oxidase inhibitor, which can cause nausea, vomiting and other side effects, according to the release.

The company said in the release that it intends to take the prodrugs down the 505(b)(2) approval pathway if the FDA approves one of the other forms of the compound now in clinical trials.