The trial’s primary endpoint sought to determine the impact of TSND-201 on PTSD symptoms over a 70-day examination period. Credit: Shutterstock / Chanintorn.v.
Transcend Therapeutics’ Phase II IMPACT-1 study examining its neuroplastigen treatment for post-traumatic stress disorder (PTSD), dubbed TSND-201, has met its primary endpoint eliciting a statistically significant drop in symptoms versus placebo.
The study included 65 patients diagnosed with severe PTSD (CAPS-5 score ≥ 35), all of whom had previously undergone PTSD treatment. They were administered four oral doses of either TSND-201 or a placebo, with each dose spaced one week apart. Patients were monitored for a total of 64 days following their first dose.
The randomised, double-blind, placebo-controlled trial (NCT05741710) used the Clinician-Administered PTSD Scale for DSM-5 (CAP5) system designed to assess the impact of 20 pre-defined symptoms, finding that TSND-201 was able to induce a -9.64-point improvement by the end of day 64.
The trial’s primary endpoint sought to determine the impact of TSND-201 on PTSD symptoms over a 70-day examination period, finding the therapy able to bring on a -8.00 drop in CAP5 score after just ten days.
As well as a lessening in symptoms, the trial also met some secondary endpoints including clinical response rate measured as a more than 50% improvement from baseline in CAP5 score, with 57.1% of TSND-201 patients meeting the target versus 19.2% in the placebo arm.
At the same time, 32.1% of patients treated with TSND-201 entered remission, defined as less than 11 points overall on the CAP5 scale, whilst only 11.5% of placebo patients saw the same.
Transcend Therapeutics CEO Blake Mandell said: “We are encouraged by the positive Phase II results demonstrating TSND-201’s potential as a rapid-acting and durable treatment for patients with PTSD.”
Alongside these results, another secondary endpoint sought to track the rate of treatment-emergent adverse events (TEAEs) finding only transient issues that occurred and were resolved on the day of dosing.
The US-based company said it plans to advance the PTSD therapy into Phase III following discussions with the US Food and Drug Administration (FDA).
The standard of care for PTSD currently relies upon trauma-focused psychological therapies such as cognitive processing therapy (CPT) alongside the use of selective serotonin reuptake inhibitors or other antidepressants. Research by GlobalData estimates that the global market for PTSD therapies stood at $236m in 2024, with that number expected to rise to more than $2bn by the end of the decade.
GlobalData is the parent company of Clinical Trials Arena.
The announcement comes after the US Military’s Defence Health Agency (DHA) partnered with the Global Coalition for Adaptive Research (GCAR) for a platform trial seeking therapies for former and active soldiers living with the condition. Meanwhile, Lykos Therapeutics said it remains dedicated to continuing the development of its midomafetamine (MDMA) treatment following an FDA refusal.
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