Reunion Neuroscience Inc. is making strides in developing next-generation psychedelic-inspired therapeutics for underserved mental health disorders. The company announced updates on its clinical programs, including the ongoing Phase 2 RECONNECT trial of RE104 for postpartum depression (PPD) and plans to initiate a Phase 2 trial of RE104 for adjustment disorder (AjD). They are also advancing RE245, a non-psychedelic compound, through preclinical studies.
RE104 for Postpartum Depression
RE104, a proprietary serotonergic neuroplastogen, is being evaluated in the RECONNECT trial, a Phase 2 study assessing its safety and efficacy in reducing depressive symptoms in women with moderate-to-severe PPD. The trial is a multicenter, randomized, double-blind, active dose-controlled study. Reunion Neuroscience anticipates completing patient enrollment and reporting topline data from the RECONNECT trial in mid-2025.
Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience, stated, "We are particularly encouraged by recent progress across our PPD program, where we remain on-track to report topline clinical data from our Phase 2 RECONNECT trial mid-year."
Postpartum depression is the most common complication of pregnancy and childbirth, affecting approximately one in five perinatal individuals up to one year after childbirth.
RE104 for Adjustment Disorder
Reunion Neuroscience plans to initiate the REKINDLE trial, a Phase 2 study evaluating RE104 in patients with adjustment disorder (AjD) related to cancer and other medical illnesses. AjD is characterized by emotional or behavioral symptoms in response to an identifiable stressor and is a frequent diagnosis managed by psychiatrists globally. The REKINDLE trial aims to assess the safety and efficacy of RE104 in reducing depressive and anxiety symptoms in this patient population. The company expects to initiate the REKINDLE trial in mid-2025.
RE245: A Non-Psychedelic Approach
In addition to RE104, Reunion Neuroscience is advancing RE245, a non-psychedelic serotonergic neuroplastogen, through preclinical development. RE245 is designed to orally deliver 5HT2A-mediated neuroplasticity, potentially offering therapeutic mental health benefits without the hallucinogenic effects associated with traditional psychedelics. Reunion plans to initiate investigational new drug (IND)-enabling studies for RE245 in 2025 and to file an IND application in 2026.
RE104 Phase 1 Data
Reunion Neuroscience presented a poster detailing RE104 Phase 1 data at the American College of Neuropsychopharmacology (ACNP) 63rd Annual Meeting in Phoenix, Arizona. The data showed that 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.
