- Late breaking oral presentation of results from the positive IMPACT-1 Phase 2 placebo-controlled trial in PTSD
- IMPACT-1 met the primary endpoint, demonstrating statistically significant placebo-adjusted CAPS-5 improvement of -9.64 on Day 64
- Results support the further development of TSND-201 as a treatment for PTSD, and potentially other CNS disorders
NEW YORK, May 27, 2025 – Transcend Therapeutics, a clinical-stage biotechnology company developing medicines to treat neuropsychiatric diseases, this week presented two posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting demonstrating TSND-201’s (methylone) potential to be the first rapid-acting treatment for PTSD.
“Results from our recently completed Phase 2 randomized, placebo-controlled trial – along with our ongoing preclinical work – support the further development of TSND-201 as a treatment for PTSD, and potentially other CNS disorders,” said Transcend Therapeutics Co-founder and CEO Blake Mandell. “With more than 13 million people in the U.S. living with PTSD and a dearth of effective treatment options, we are working expeditiously to align with the FDA on a Phase 3 program in PTSD.”
Summary of presentations:
TSND-201 Demonstrated Rapid, Robust, and Durable Therapeutic Efficacy in a Randomized, Placebo-Controlled Trial (IMPACT-1) for the Treatment of Post-Traumatic Stress Disorder (Oral presentation – Tuesday, May 27; Poster presentation – Wednesday, May 28)
- Treatment with TSND-201 resulted in rapid and robust improvements in PTSD symptoms
- Placebo-adjusted CAPS-5 improvement of -9.64 points on Day 64 (p=0.012)
- Durable efficacy following an acute episodic dosing regimen (once per week for 4-weeks)
- TSND-201 was generally safe and well tolerated, with a safety profile consistent with its non-hallucinogenic pharmacology
TSND-201 (Methylone) as a Treatment for PTSD: Rapid, Robust, and Long-Lasting Activity in Phase 2 (Poster Presentation – Thursday, May 29)
- TSND-201 is a non-hallucinogenic, rapid acting neuroplastogen that increases neurite outgrowth
- Preclinical results demonstrate rapid, robust, and long-lasting benefit tests of PTSD, anxiety, depression
About Transcend Therapeutics
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 leadership team has made pivotal contributions to 14 FDA approvals and $7B in M&A and public company value. Transcend has raised approximately $50M to date.
About TSND-201
TSND-201, a rapid-acting neuroplastogen, is a proprietary formulation of methylone developed by Transcend Therapeutics. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5HT-2a (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications. TSND-201 is an investigational medication.
About PTSD
PTSD is a mental health condition that can occur after experiencing or witnessing a life-threatening or traumatic event. Symptoms may include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event. PTSD impacts approximately 13 million Americans each year and it is estimated that nearly 7% of U.S. adults will be diagnosed with PTSD during their lifetime. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), yet their efficacy is modest at best. New treatments for PTSD are urgently needed.
Contact: press@transcendtherapeutics.com
