Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success

Reunion Neuroscience's psychedelic therapy RE104 met its primary endpoint in a Phase II trial for postpartum depression (PPD), showing statistically significant improvements over active control in the RECONNECT trial3.

Patients receiving 30mg RE104 experienced a 23.0-point reduction in MADRS total scores after 7 days, versus 17.2 points for the 1.5mg active control group3.

77.1% of the 30mg RE104 group saw at least 50% improvement from baseline in depression scores, compared to 61.6% for the active control3.

71.4% of patients receiving 30mg RE104 were in remission by day 7, compared to 41% in the control group, with benefits sustained up to 28 days post-treatment3.

The safety profile of RE104 was favorable, with no serious adverse events or increase in suicidal ideation observed in the trial35.

Based on these results, Reunion will advance RE104 into a Phase III (pivotal) clinical trial for PPD in 20263.

Earlier Phase I data showed RE104 produces an intense but shorter psychedelic experience than psilocybin, is generally well-tolerated, and led to the selection of 30mg as the target dose for further trials5.

Sources:

3. https://www.clinicaltrialsarena.com/news/reunions-psychedelic-therapy-to-advance-after-phase-ii-ppd-success/

5. https://www.biospace.com/press-releases/reunion-neuroscience-announces-publication-of-re104-phase-1-data-in-the-journal-of-clinical-psychopharmacology