Terran Biosciences Granted US Patent for the World's First New Forms of MDMA, Potentially Clearing the Path to a Future 505(b)(2) Approval

Terran Biosciences, Inc. ("Terran"), a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has been awarded patent US 11,958,821 from the United States Patent and Trademark Office (USPTO) covering the world's first new salts and polymorphs of MDMA (MDMA hemifumarate), pharmaceutical compositions using these forms, and the method of use for treating post-traumatic stress disorder (PTSD). Terran now holds the only granted composition of matter patent on a new form of MDMA. MDMA was originally invented by Merck in 1912 and the clinical trials of MDMA to date have been limited to using the older forms of MDMA hydrochloride (MDMA HCl) described in the historical literature.

MDMA HCl has been submitted to the FDA for approval on the 505(b)(1) path and is currently undergoing FDA review, with a decision expected by August this year. If the FDA approves MDMA HCl, Terran plans to use its new form of MDMA hemifumarate to pursue a rapid 505(b)(2) FDA approval pathway. 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 MDMA product to market approximately five years after the first MDMA approval, regardless of any listing in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for the older MDMA HCl. Terran's novel approach is designed to help broaden access for patients and increase affordability. To realize this goal, Terran has already developed a new GMP manufacturing process and is making MDMA available to researchers and clinics worldwide.

"With this new breakthrough, we are committed to bringing affordable and accessible MDMA treatment options to patients with PTSD," said Sam Clark, MD, PhD, inventor of the patent and Terran's founder and CEO. "We believe this new form of MDMA will enable us to bypass any potential future Orange Book listing, eliminating the potential for a 30-month stay that could otherwise delay the entry of generic MDMA HCl. MDMA-assisted psychotherapy could revolutionize the treatment of PTSD and Terran will ensure that affordable MDMA is not delayed."

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.