Positive Results for Novel PTSD Treatment Primary Endpoint Met in Transcend Therapeutics IMPACT-1 Study
A primary endpoint is the main measure researchers use to see if the drug works.
TSND-201 is the experimental drug tested.
CAPS-5 is a standard assessment scale for PTSD (Clinician-Administered PTSD Scale for DSM-5). A higher score indicates more severe PTSD symptoms. A lower (negative) number means symptoms have improved.
We’re thrilled to share that our research partners at Transcend Therapeutics have just announced positive Phase 2 results for their groundbreaking TSND-201 in treating PTSD.
IMPACT-1 was a randomized, double-blind, placebo-controlled, Phase 2 clinical trial evaluating TSND-201 (methylone), a rapid-acting neuroplastogen, for the treatment of PTSD. This study enrolled 65 patients with severe PTSD (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5] ≥ 35), all of whom had previously tried a PTSD treatment, to receive 4 oral doses of TSND-201 or placebo, with each dose separated by one week. Patients were followed for a total of 64 days after the first dose.
A significant cohort of these 65 patients were recruited and enrolled via Mirabilis Health, which was the first site in the world to prescribe and dispense methylone in the treatment of PTSD.
On the primary endpoint, change from baseline to Day 64, TSND-201 demonstrated a statistically significant placebo-adjusted CAPS-5 improvement of -9.64 points on Day 64. TSND-201 also demonstrated rapid and statistically significant improvements from baseline compared to placebo on the CAPS-5 total severity score. Starting on Day 10, TSND-201 demonstrated a statistically significant placebo-adjusted CAPS-5 improvement of -8.00 points, which was durable throughout the study until Day 64.
Professor Paul Miller, founder of Mirabilis Health said “These findings are profoundly encouraging. As someone with nearly 30 years in psychiatry, for too long, those suffering from PTSD have had limited treatment options, often with slow or insufficient relief. To see such rapid, significant improvement from TSND-201 — especially among individuals with severe, treatment-resistant PTSD — marks a potential turning point in trauma-informed care. We’re honoured that Mirabilis Health could play a pioneering role in this study and are proud to contribute to research that holds real promise for healing in Northern Ireland.”
“It has been over two decades without a new treatment for PTSD. The results of this study suggest that TSND-201 may represent a significant clinical breakthrough — demonstrating clinically meaningful efficacy with a rapid onset,” commented Murray B. Stein, M.D., M.P.H., Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and Staff Psychiatrist at the Veteran Affairs San Diego Healthcare System. “Rapid-acting, episodic treatments could be a paradigm shift in the treatment of PTSD, providing hope for the many patients who have struggled to find effective relief.”
To read the full press release follow the link below: