NEW YORK, DEC. 5, 2023 – Transcend Therapeutics, a clinical-stage biotechnology company that develops medicines to treat neuropsychiatric diseases, today presented the positive results from its Phase 2 clinical trial evaluating TSND-201 (methylone) as a treatment for Post-Traumatic Stress Disorder (PTSD) at the American College of Neuropsychopharmacology (ACNP) Annual Meeting.
The 14-patient Part A open-label trial – where patients were treated with TSND-201 once a week for 4 weeks – demonstrated rapid and robust effects on PTSD symptoms. TSND-201 demonstrated statistically significant changes from baseline on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at each post-dose assessment. These results demonstrated rapid efficacy, with a mean change from baseline of -8.4 points (p=0.002) two days after the first dose. TSND-201 provided robust improvements in CAPS-5 throughout the 4 dosing sessions. One week following the last dose, the mean change from baseline in CAPS-5 was -31.9 points (p<0.0001). Six weeks after the last dose, the results were durable with a mean change from baseline in CAPS-5 of -36.2 points (p<0.0001). Remission, defined as a CAPS-5 total score of ≤11, was achieved by the majority of participants (61.5%) at the end of study.
In addition to improving PTSD symptoms, TSND-201 also demonstrated a substantial and statistically significant reduction from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) total severity score at each post-dose assessment. One week following the last dose, the mean change from baseline was -19.4 points (p=0.002). Six weeks after the last dose, the results were durable with a mean change from baseline of -21.4 points (p<0.0001), with 61.5% of participants achieving remission of depressive symptoms (MADRS total score ≤10).
The treatment was generally safe and well tolerated. The most common treatment-related adverse event was headache. No treatment-related serious adverse events were reported. One serious adverse event of ‘victim of assault’ occurred 20 days after the participant’s last dose.
“We are pleased to share our initial open-label Part A results, which suggest that TSND-201 has the potential to provide rapid and durable improvements on PTSD symptoms,” Transcend Therapeutics Co-Founder and CEO Blake Mandell said. “These results support our hypothesis that TSND-201 has the potential to be a best-in-class treatment for PTSD. We look forward to seeing these results confirmed during the randomized, placebo-controlled portion of the study.”
View the full ACNP poster.
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 is open-label and Part B is randomized, double-blind, and placebo-controlled. 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.
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, major depressive disorder (MDD), and other central nervous system (CNS) indications.
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. Yet, currently approved medications (sertraline and paroxetine) for treatment of PTSD have modest efficacy; less than 30% of patients treated with currently approved medications achieve remission.
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 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.