Press Release

Transcend and Yale awarded U.S. Department of Defense grant to study methylone for PTSD

Transcend Therapeutics is developing one of the most promising psychoactive compounds – with previous human experience to treat PTSD.

Company also announces that the IMPACT-1 clinical trial is underway with open-label results expected in the coming months.

September 21, 2023

Transcend Therapeutics, a biotechnology company developing rapid-acting treatments for neuropsychiatric diseases, announced receipt of a collaborative grant award with Yale University to support first-of-its-kind preclinical research on methylone – Transcend’s lead compound for the treatment of post-traumatic stress disorder (PTSD). Yale University received a three-year, $1 million grant from the U.S. Department of Defense to conduct preclinical research using state-of-the-art microscopy and behavioral methods to understand the neurobiological mechanism underlying methylone’s rapid-acting, long-lasting behavioral and therapeutic effects in PTSD.

“We know from a published clinical case series and other research that methylone could hold tremendous promise for the treatment of PTSD,” Transcend Co-Founder and CEO Blake Mandell said. “Yale’s research, funded by the Department of Defense, will provide invaluable data on the neuroplastic effects of methylone on the brain.”

Transcend is currently conducting IMPACT-1, a clinical trial in the United Kingdom evaluating the safety and efficacy of methylone in patients with severe PTSD. Transcend expects top-line data from the open-label Part A by the end of 2023. Following completion of the open-label Part A, Transcend will launch Part B, a randomized, double-blind, placebo-controlled, evaluation of methylone with up to 64 patients with PTSD.

“There is a tremendous demand, especially among veterans, for new and effective treatments for PTSD,” said Transcend Co-Founder and Chief Scientific Advisor Ben Kelmendi, MD. Dr. Kelmendi also serves as Medical Advisor at the U.S. Department of Veterans Affairs National Center for PTSD and co-director of the Yale Program for Psychedelic Science.

Transcend Therapeutics, founded in 2021, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company’s mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Transcend’s lead product candidate, methylone, a rapid-acting neuroplastogen, is currently being evaluated in a Phase 2 study in PTSD. Transcend’s leadership team has made pivotal contributions to 13 FDA approvals and $7B in M&A and public company value. As a Public Benefit Corporation, Transcend has pledged 10% of its founding shares toward nonprofits focused on scientific research and patient access.