New York, Dec. 11, 2024 – Transcend Therapeutics, a clinical-stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases, today presented two posters at the American College of Neuropsychopharmacology (ACNP) Annual Meeting taking place in Phoenix, Arizona, highlighting the promise of TSND-201 for PTSD and other CNS conditions.
“This additional clinical and preclinical data gives us further confidence that TSND-201 could offer a rapid-acting, durable alternative to existing PTSD treatments for the 13 million Americans who suffer from PTSD,” said Transcend Therapeutics Co-Founder and CEO Blake Mandell. “We look forward to continuing to advance our ongoing Phase 2 trial of TSND-201 for PTSD and sharing results from the randomized, placebo-controlled portion of the trial in the second quarter of 2025.”
Summary of poster presentations:
- TSND-201 demonstrated rapid, robust, and consistent improvements across each PTSD symptom domain (Intrusion, Avoidance, Cognition and Mood, Arousal and Reactivity).
- Rapid and durable improvement on anxiety symptoms occurred concurrently with PTSD symptom improvement.
- TSND-201 was generally safe and well tolerated; the most common adverse events (AEs) were headache and decreased appetite.
- Randomized, placebo-controlled study is ongoing, with results expected in Q2 2025.
TSND-201 (Methylone): A Rapid-Acting Neuroplastogen that Stimulates Neurite Outgrowth
- TSND-201 increases neurite outgrowth and branching via well-studied mechanisms (i.e., monoamines, neurotrophins, and mTor).
- Preclinical results add to understanding of TSND-201’s mechanism of action.
- Demonstrates direct neurotrophic effects of TSND-201 for the first time.
- Confirms that neuroplastic effects are mediated by TSND-201’s known pharmacological targets (serotonin, norepinephrine, dopamine transporters) – connecting the dots between primary pharmacology and long-lasting neuroplasticity.
- Underscores TSND-201’s potential as a rapid, robust, and long-lasting pharmacotherapy for PTSD and other CNS disorders.
About TSND-201
TSND-201 – a rapid-acting neuroplastogen for post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and other mood disorders – 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 receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD, major depressive disorder (MDD), and anxiety indications. TSND-201 is an investigational drug product not approved by the FDA.
About IMPACT-1
IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder) is a 2-part trial evaluating the safety and efficacy of TSND-201 for the treatment of PTSD. Part A was open-label (positive results announced in December 2023); Part B (currently enrolling) is randomized, double-blind, and placebo-controlled, with results expected in Q2 2025. Eligible participants are adults with a confirmed diagnosis of PTSD using the DSM-5 criteria and a CAPS-5 total severity score of ≥35. Study drug is dosed once a week for 4 weeks. During each of the 4 dosing sessions, participants are accompanied by a trained mentor who provides non-directive psychological support. After the 4-week treatment period, participants attend follow-up visits at 1, 2, 3, and 6 weeks following the last dose.
About Transcend
Transcend Therapeutics is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for PTSD and other neuropsychiatric disorders. The company’s leadership team has made pivotal contributions to 13 FDA approvals, $3.5B in M&A, and significant public company value creation. Transcend’s goal is to develop TSND-201 across multiple blockbuster indications — PTSD, depression, and anxiety. Transcend has raised approximately $50M to date.
Contact: press@transcendtherapeutics.com
