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Reunion Neuroscience Announces First Patient Dosed in REKINDLE Phase 2 Clinical Trial of RE104 for the Treatment of Adjustment Disorder (AjD) in Cancer and Other Medical Illnesses
Globenewswire· 2025-09-30 11:30
Core Insights - Reunion Neuroscience is advancing RE104, a psychedelic-inspired therapeutic solution, targeting significant unmet needs in mental health disorders, specifically Adjustment Disorder (AjD) and postpartum depression (PPD) [1][2][3] Company Overview - Reunion Neuroscience is a clinical-stage biopharmaceutical company focused on developing next-generation psychedelic therapies for underserved mental health conditions [7] - The company aims to address conditions like AjD, PPD, and Generalized Anxiety Disorder (GAD) with innovative treatments that have no current FDA-approved options [1][7] Product Development - RE104 is the only psychedelic therapeutic in advanced clinical development for AjD in the U.S., designed to provide rapid and sustained relief from distress and dysfunction [2][3] - The company has initiated the REKINDLE Phase 2 trial for RE104 in AjD, with topline results expected in 2027, and plans to start a Phase 3 trial for PPD in 2026 [1][4] - Positive topline data from the RECONNECT Phase 2 trial for PPD demonstrated a significant reduction in depression severity, supporting the advancement of RE104 into further trials [4] Market Need - AjD affects approximately 500,000 individuals in the U.S. annually, particularly those with serious medical illnesses, and is associated with poorer medical outcomes and quality of life [3][5][6] - Current treatments for AjD are inconsistent, highlighting the need for effective therapies like RE104 [6] Clinical Trial Details - The REKINDLE trial is a randomized, double-blind, dose-controlled study assessing the safety and efficacy of RE104 in adult patients with AjD [3][4] - Primary and secondary endpoints include changes in depression and anxiety severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A) [3]