Transcend’s neuroplastogen posts positive mid-stage results in PTSD

Transcend Therapeutics has announced positive results from their Phase 2 IMPACT-1 study evaluating TSND-201 (methylone) for the treatment of post-traumatic stress disorder (PTSD)1 3 6.

Key Findings

- Primary endpoint met:
TSND-201 demonstrated a statistically significant placebo-adjusted improvement of -9.64 points on the CAPS-5 scale at Day 64 (p = 0.011)1 3 6

- Rapid onset of action:
A statistically significant placebo-adjusted improvement of -8.00 points was observed as early as Day 10 (p = 0.012)1 3 6

- Durable effects:
Improvements remained statistically significant throughout the 64-day study period1 3

- Secondary endpoints:
Significant improvements were seen in response rate, remission rate, and loss of PTSD diagnosis1 3 6

Efficacy Details

57.1% of TSND-201 patients achieved ≥50% improvement from baseline on CAPS-5, compared to 19.2% for placebo (p = 0.002)1 3 6
32.1% of TSND-201 patients achieved remission (CAPS-5 ≤11), versus 11.5% for placebo (p = 0.036)1 3 6
60.7% of TSND-201 patients lost their PTSD diagnosis, compared to 30.8% for placebo (p = 0.014)1 3 6

Safety and Tolerability

TSND-201 was generally safe and well-tolerated1 3 6. The most common adverse events included headache, decreased appetite, nausea, dizziness, blood pressure increase, dry mouth, insomnia, muscle tightness, and feeling abnormal1 3. One serious adverse event of seizure occurred 7 days after the last dose in a patient with a history of seizure, considered unrelated to the study drug1 3.

Study Design

IMPACT-1 was a randomized, double-blind, placebo-controlled trial enrolling 65 patients with severe PTSD (CAPS-5 ≥35)1 3. Patients received 4 oral doses of TSND-201 or placebo, given once weekly, and were followed for 64 days1 3.

Next Steps

Transcend Therapeutics plans to meet with the FDA to align on a Phase 3 program for PTSD1 3 6.

This study represents a potential breakthrough in PTSD treatment, as there have been no new approved therapies for over two decades1 3. The rapid onset and durable effects of TSND-201 could offer new hope for patients struggling with this challenging condition.

Sources:

1. https://transcendtherapeutics.com/impact-1-primary-endpoint-met/

3. https://www.biospace.com/press-releases/transcend-therapeutics-announces-primary-endpoint-met-in-impact-1-phase-2-study-of-tsnd-201-in-ptsd

6. https://www.prnewswire.com/news-releases/transcend-therapeutics-announces-primary-endpoint-met-in-impact-1-phase-2-study-of-tsnd-201-in-ptsd-302415138.html