Reunion Neuroscience Inc. announced that the first patient has been dosed in the RECONNECT Phase 2 clinical trial of RE104 for the treatment of postpartum depression (PPD). RE104 was designed to be a safe, fast-acting, single-dose therapy to benefit patients suffering from underserved mental health disorders, including PPD. The RECONNECT Phase 2 clinical trial (NCT06342310) is a multicenter, randomized, double-blind, parallel-group, active dose-controlled clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD.
The primary endpoint of the trial is the change in total Montgomery-Åsberg Depression Rating Scale (MADRS) score, a 10-item clinician rated scale measuring depression severity from baseline, at Day 7. Key secondary endpoints include the change in total MADRS score from baseline at Day 1, 14 and 28, MADRS response indicating a = 50% reduction in symptoms, MADRS remission with a score of = 10, as well as safety and tolerability. The Company?s lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. Reunion designed RE104 to deliver a short duration psychedelic experience compared to longer duration psychedelics like psilocybin.
In a Phase 1 clinical trial, RE104 produced a psychedelic state similar in intensity and quality to psilocybin, but lasting only about half the time (3-4 hours), while demonstrating a similar, favorable safety profile. RE104 is currently being evaluated in the RECONNECT Phase 2 (NCT06342310) clinical trial, a multicenter, randomized, double-blind, active dose-controlled clinical trial in moderate-to-severe Postpartum Depression (PPD) patients. Reunion is actively evaluating the use of RE104 in additional neuropsychiatric indications, including adjustment disorder in cancer patients, where there remains a significant unmet need that is not addressed by the current standard of care.
Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy and is estimated to affect approximately 10-15% of all mothers of newborns. PPD is a form of major depression that can severely impact women and their families. According to the Centers for Disease Control and Prevention, the leading underlying cause of pregnancy-related death during the first postpartum year are due to mental health conditions, with suicide being the leading manner of death.
Women suffering from PPD often experience significant changes in mood, appetite and sleep contributing to feelings of hopelessness, lack of concentration, loss of energy, poor self-esteem and maternal disinterest.
About Reunion Neuroscience Inc.
Reunion Neuroscience is committed to pushing the boundaries of neuroscience to develop innovative therapeutic solutions for postpartum depression (PPD) and other underserved mental health disorders. In August of 2023, Reunion Neuroscience was acquired by MPM BioImpact, a world-leading biotechnology investment firm with three decades of experience creating and investing in innovative biotechnology companies seeking to deliver transformative therapies to patients. As part of the MPM BioImpact portfolio, the Company is evaluating its lead asset, RE104, a proprietary, potential best-in-class, serotonergic psychedelic compound and the only 4-OH-DiPT prodrug in clinical development, as a potential treatment for postpartum depression, (NCT06342310), that could provide rapid symptom relief and durable efficacy. Reunion is actively investigating the use of RE104 in additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care.