Reunion Neuroscience Inc. Begins Phase 2 Trial of RE104 for Postpartum Depression

On July 23, 2024, Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company dedicated to advancing neuroscience, announced the commencement of patient dosing in the RECONNECT Phase 2 clinical trial of RE104, aimed at treating postpartum depression (PPD). Designed as a safe, fast-acting, single-dose therapy, RE104 aims to address significant unmet needs in mental health care, including PPD.

Greg Mayes, President and CEO of Reunion Neuroscience, emphasized the importance of this trial in their mission to enhance the lives of those affected by PPD. He noted the critical need for rapid, effective, single-dose treatments with lasting efficacy and reiterated Reunion's commitment to addressing the broader challenges in mental health through their research and development efforts.

The RECONNECT Phase 2 trial (NCT06342310) is a multicenter, randomized, double-blind, parallel-group, active dose-controlled study. It focuses on evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult females with moderate-to-severe PPD. The study's primary endpoint is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score, which measures depression severity, from baseline to Day 7. Secondary endpoints include changes in MADRS scores at Days 1, 14, and 28, response rates indicating a symptom reduction of 50% or more, remission rates with scores of 10 or less, and overall safety and tolerability.

RE104, the company's leading product candidate, is a patented prodrug of 4-OH-DiPT, potentially best-in-class. It was designed to induce a shorter duration psychedelic experience compared to substances like psilocybin. Data from a Phase 1 trial showed that RE104 produced a psychedelic state comparable in intensity and quality to psilocybin, but with a duration of only about 3-4 hours, and a similar safety profile. Currently, RE104 is under evaluation in the RECONNECT Phase 2 trial for moderate-to-severe PPD patients. Reunion Neuroscience is also exploring RE104's potential in other neuropsychiatric conditions, including adjustment disorder in cancer patients, where current treatments fall short.

Postpartum depression (PPD) is a prevalent complication during and after pregnancy, affecting an estimated 10-15% of new mothers. Recognized as a severe form of major depression, PPD can significantly impact both women and their families. According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of pregnancy-related deaths in the first year postpartum, with suicide being the primary cause. Women with PPD often experience drastic mood changes, altered appetite and sleep patterns, leading to feelings of hopelessness, concentration difficulties, fatigue, low self-esteem, and lack of interest in maternal responsibilities. There is a pressing need for treatments that offer rapid symptom relief, efficacy with just one dose, and a quick return to normalcy.

Reunion Neuroscience strives to innovate in the field of neuroscience, developing therapeutic solutions for PPD and other mental health disorders. In August 2023, the company transitioned to a private entity under the MPM BioImpact portfolio. By May 2024, Reunion had secured $103 million in Series A financing, co-led by MPM BioImpact and Novo Holdings. Beyond PPD, Reunion is actively researching the application of RE104 in other neuropsychiatric conditions, including adjustment disorders in cancer patients, to address significant unmet clinical needs.