Reunion Neuroscience Inc. announced today that the first patient has been dosed in its RECONNECT Phase 2 clinical trial evaluating RE104 for the treatment of postpartum depression (PPD). This milestone advances the company's mission to develop fast-acting, single-dose therapies for underserved mental health conditions.
RE104, the company's lead candidate, was specifically designed to provide a shorter psychedelic experience compared to traditional options like psilocybin, while maintaining therapeutic efficacy for patients suffering from moderate-to-severe PPD.
"Dosing the first patient in our RECONNECT Phase 2 trial represents an important step forward in our mission of improving the lives of patients and families impacted by PPD," said Greg Mayes, President and Chief Executive Officer of Reunion. "There is a clear need for fast-acting, single-dose treatments with durable efficacy for PPD patients."
Trial Design and Endpoints
The RECONNECT Phase 2 clinical trial (NCT06342310) employs a multicenter, randomized, double-blind, parallel-group, active dose-controlled design. The study will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD.
Researchers will measure efficacy primarily through changes in the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-rated scale that assesses depression severity. The primary endpoint is the change in total MADRS score from baseline at Day 7.
Key secondary endpoints include:
- Changes in MADRS scores at Days 1, 14, and 28
- MADRS response rate (≥50% reduction in symptoms)
- MADRS remission rate (score ≤10)
- Safety and tolerability assessments
RE104: A Novel Approach to Psychedelic Therapy
RE104 is a proprietary, patented prodrug of 4-OH-DiPT developed to address limitations of existing psychedelic treatments. In Phase 1 trials, RE104 produced psychedelic effects comparable to psilocybin in intensity and quality, but with a significantly shorter duration of 3-4 hours (approximately half the time of psilocybin).
This shortened duration could offer practical advantages for clinical implementation while maintaining a favorable safety profile. The subcutaneous administration route being tested in the current trial may provide additional convenience compared to other delivery methods.
Beyond PPD, Reunion is exploring RE104's potential in other neuropsychiatric indications, including adjustment disorder in cancer patients, where current treatment options often fall short.
Addressing the Significant Burden of Postpartum Depression
Postpartum depression affects approximately 10-15% of new mothers, making it one of the most common complications during and after pregnancy. The condition can have devastating effects on women and their families, with the Centers for Disease Control and Prevention identifying mental health conditions as the leading underlying cause of pregnancy-related death during the first postpartum year.
Women with PPD typically experience significant changes in mood, appetite, and sleep patterns, along with feelings of hopelessness, poor concentration, energy loss, diminished self-esteem, and reduced interest in maternal care.
Current treatment options for PPD often require multiple doses, have delayed onset of action, or involve extended hospital stays. Reunion believes RE104 could address these limitations by offering faster onset, greater efficacy with a single dose, and quicker return to normal daily activities.
Company Background
Reunion Neuroscience has undergone significant changes in recent years. In August 2023, the company transitioned to private ownership as part of the MPM BioImpact portfolio. More recently, in May 2024, Reunion completed a substantial $103 million Series A financing round co-led by MPM BioImpact and Novo Holdings.
This funding strengthens the company's position as it advances RE104 through clinical development for PPD and explores additional neuropsychiatric indications with significant unmet needs.
As the RECONNECT trial progresses, Reunion aims to generate data that could potentially transform the treatment landscape for postpartum depression and establish a foundation for addressing other mental health disorders with its novel psychedelic approach.
