Transcend Posts Positive Phase 2 Data from Methylone for PTSD Program

Words by Josh Hardman with support from Psychedelic Alpha Medical Advisor Michael Haichin.

Today, Transcend Therapeutics shared topline results from its Phase 2 study of the MDMA analog methylone (TSND-201) in PTSD.

The trial, IMPACT-1 (NCT05741710), enrolled 65 severe PTSD patients to receive either methylone or placebo capsules once weekly for four weeks, without wrap-around psychotherapy. (The company has previously discussed the non-pharmacological support provided: “During each of the 4 dosing sessions, participants are accompanied by a trained mentor who provides non-directive psychological support.”)

Transcend has not disclosed specific dosages, though an EU clinical trial registry entry for a long term extension of IMPACT-1 specifies that the capsules are 50 mg each and up to 150 mg is the max daily dose. A poster presentation shared by the company (see our earlier coverage for more) provides a further hint: it says that, during the Open-Label section of the present study (Part A), patients received “an initial dose, followed by a second dose 90 minutes later.” One might assume the initial dose is 100 mg, followed by a 50 mg booster.

Specifics aside, the headline from today’s readout is that those in the methylone arm of the study demonstrated a statistically significant placebo-adjusted CAPS-5 improvement of -8.00 at day 10 and -9.64 at day 64...