Transcend Therapeutics Achieves Primary Endpoint in Phase 2 PTSD Study of TSND-201

Transcend Therapeutics, a biotechnology company focused on developing treatments for neuropsychiatric disorders, has announced promising results from its IMPACT-1 study. This Phase 2 clinical trial investigated the efficacy of TSND-201, a rapid-acting neuroplastogen, in treating Post-Traumatic Stress Disorder (PTSD).

The IMPACT-1 trial was a rigorous, randomized, double-blind, placebo-controlled study. It involved 65 patients suffering from severe PTSD, each with a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 35 or higher. Participants were previously treated for PTSD but continued to experience symptoms. These patients received four doses of TSND-201 or a placebo, with a week between each dose, over a span of 64 days.

The study’s primary endpoint was to measure the change in CAPS-5 scores from baseline to Day 64. The results were notable, with TSND-201 showing a statistically significant placebo-adjusted improvement of -9.64 points in CAPS-5 scores on Day 64, with a p-value of 0.011. The treatment demonstrated a rapid effect, with significant changes observed as early as Day 10, showing a placebo-adjusted improvement of -8.00 points (p = 0.012). These improvements were sustained throughout the trial duration.

CEO Blake Mandell expressed optimism about TSND-201's potential as a fast-acting and lasting treatment option for PTSD patients. He emphasized the company's intent to collaborate with the FDA to advance to a Phase 3 trial.

Beyond the primary endpoint, TSND-201 also achieved statistically significant improvements on several secondary endpoints by Day 64. These included response rates (≥ 50% improvement from baseline on CAPS-5), with 57.1% of the TSND-201 group responding compared to 19.2% in the placebo group (p = 0.002). Additionally, remission rates (CAPS-5 scores of ≤ 11) were higher in the TSND-201 group at 32.1%, compared to 11.5% in the placebo group (p = 0.036). The loss of PTSD diagnosis was also more common in the TSND-201 group, with 60.7% achieving this outcome compared to 30.8% in the placebo group (p = 0.014).

Safety was another critical aspect of the trial, with TSND-201 being generally well tolerated. Most adverse events were mild and resolved on the same day they occurred. Common side effects included headache, decreased appetite, nausea, dizziness, and insomnia, among others. Notably, there was one incident of a serious adverse event, a seizure, in a patient with a prior history, but it was deemed unrelated to the study drug.

Murray B. Stein, a Distinguished Professor of Psychiatry, highlighted the potential breakthrough that TSND-201 represents. He pointed out that it could herald a new era of rapid-acting, episodic treatments for PTSD, offering hope to many patients who have not found relief with existing options.

Transcend Therapeutics, established in 2021, aims to create innovative treatments for neuropsychiatric conditions. With a leadership team responsible for numerous FDA approvals, the company focuses on developing solutions for those unresponsive to current psychiatric medications. TSND-201 is one such development, a rapid-acting neuroplastogen targeting monoamine transporters, without hallucinogenic effects. The company is advancing it as a treatment for PTSD and other central nervous system disorders.

Post-Traumatic Stress Disorder is a significant mental health issue, affecting millions of Americans each year. Despite its prevalence, effective treatments are limited, with only two medications currently FDA-approved. The need for innovative therapeutic options is urgent, and TSND-201 could potentially fill this gap.