Clinical-stage biopharmaceutical company Reunion Neuroscience has reported positive topline results from its RECONNECT Phase 2 trial evaluating RE104 for postpartum depression treatment. The single-dose subcutaneous injection met its primary endpoint, showing a statistically significant reduction in depression scores compared to a lower-dose control.
The trial enrolled 84 adult women with moderate-to-severe postpartum depression across 38 U.S. clinical sites. Patients receiving a 30mg dose of RE104 demonstrated a 23.0-point reduction from baseline in Montgomery-Åsberg Depression Rating Scale scores on Day 7, compared to 17.2 points for those receiving a 1.5mg dose (p=0.0094).
Results showed 77.1% of patients treated with the 30mg dose achieved response to therapy at Day 7, defined as at least 50% improvement from baseline, compared to 61.6% in the control group. Additionally, 71.4% of patients in the higher dose group achieved remission versus 41.0% in the control group.
The treatment was generally well-tolerated with no serious adverse events reported. The most common side effects were nausea (43.9% of patients) and headache (34.1%), which were generally mild to moderate and resolved spontaneously. Notably, 92.7% of patients were ready for discharge within four hours following treatment.
“PPD remains the most common complication of pregnancy and childbirth in the U.S., affecting approximately 15% of new mothers within the first year after giving birth, with nearly 500,000 women in the U.S. diagnosed annually,” said Dr. Anita H. Clayton, lead investigator and Chair of Psychiatry at the University of Virginia School of Medicine.
Preliminary data from a lactation study suggests mothers could potentially return to breastfeeding rapidly following RE104 treatment, with less than 0.1% of the administered dose detected in breast milk metabolites.
“With PPD, it can seem as if women are watching life from the sidelines, feeling emotionally detached, lacking joy, and unable to bond with their newborns,” said Dr. Camille Hoffman, Professor of Maternal Fetal Medicine at the University of Colorado School of Medicine. “Our current treatment options are limited, and we need therapies that help our patients recover rapidly during such a dynamic time of life.”
RE104 is a proprietary prodrug of 4-OH-DiPT administered via single subcutaneous injection, designed to deliver a shorter psychoactive experience compared to other psychedelic therapies. Based on these results, Reunion plans to initiate a pivotal Phase 3 trial in 2026.
