Reunion Neuroscience Announces Positive Topline Results from RECONNECT Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression (PPD)

Core Insights - Reunion Neuroscience, Inc. announced positive topline results from its RECONNECT Phase 2 clinical trial for RE104, demonstrating a significant reduction in postpartum depression (PPD) symptoms [1][3][8] - The company plans to initiate a pivotal Phase 3 trial for RE104 in PPD in 2026, following the promising results from the Phase 2 trial [1][9][10] Clinical Trial Results - RECONNECT trial met its primary endpoint with a 30mg dose of RE104 showing a 23.0-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score on Day 7, compared to a 17.2-point reduction in the control group [1][11] - 77.1% of patients treated with RE104 30mg showed a response to therapy at Day 7, while 71.4% were in remission, significantly higher than the control group [2][3] - Clinically meaningful reductions in MADRS were observed from Day 1 and maintained through Day 28 follow-up [1][2] Safety and Tolerability - RE104 was generally well-tolerated, with no serious adverse events reported; 92.7% of patients were ready for discharge within four hours post-administration [4][6] - Common treatment-emergent adverse events included nausea (43.9%) and headache (34.1%), which were mild to moderate and resolved spontaneously [5][6] Lactation Study Insights - Preliminary data from a lactation study indicated that the amount of RE104 metabolites in breastmilk was less than 0.1% of the administered dose, suggesting minimal risk for breastfeeding mothers [7][4] Future Development Plans - The company is also evaluating RE104 for adjustment disorder (AjD) related to cancer and other medical illnesses, with plans to initiate the REKINDLE Phase 2 trial in Q3 2025 [8][10] - Reunion aims to address a range of underserved mental health conditions with RE104, potentially redefining the standard of care for PPD and AjD [8][15]