MORRISTOWN, N.J. — September 30, 2025 — Leads & Copy — Reunion Neuroscience, Inc. has announced the dosing of the first patient in REKINDLE, a Phase 2 clinical trial evaluating RE104 for the treatment of adjustment disorder (AjD) in patients with cancer and other medical illnesses. The clinical-stage biopharmaceutical company is committed to revolutionizing the treatment of underserved mental health disorders through next-generation psychedelic-inspired therapeutic solutions. Topline results from the study are anticipated in 2027.
With RE104, Reunion Neuroscience aims to offer patients an effective, safe and fast-acting psychotropic medication to relieve distress and dysfunction in patients with AjD. RE104 is the only psychedelic therapeutic in advanced clinical development for an AjD indication in the United States.
Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience, stated that dosing the first patient in the REKINDLE Phase 2 trial marks a significant milestone in their mission to bring RE104 to patients living with underserved mental health disorders. He added that their confidence in RE104 is buoyed by positive topline data from the RECONNECT trial of RE104 for the treatment of PPD, which demonstrated RE104’s ability to deliver rapid and safe symptom relief following a single dose. The company plans to expand its clinical development efforts and work to realize the full potential of RE104, with plans to initiate a Phase 3 trial of RE104 in Postpartum Depression (PPD) in 2026 and a RECLAIM Phase 2 Trial in Generalized Anxiety Disorder (GAD) in 1Q 2026.
The REKINDLE Phase 2 clinical trial (NCT07002034) is a randomized, double-blind, parallel-group, dose-controlled clinical trial evaluating the safety and efficacy of RE104 for the treatment of AjD in adult patients with cancer and other medical illnesses. The primary endpoint of the trial is the change from baseline in total Montgomery-Åsberg Depression Rating Scale (MADRS) score, a clinician rated scale measuring depression severity. A key secondary endpoint of the trial is the change from baseline in the Hamilton Anxiety Scale (HAM-A), a clinician rated scale measuring anxiety severity. The study will also assess the safety and tolerability of RE104.
Reunion Neuroscience recently announced topline data from RECONNECT (NCT06342310), a multicenter, randomized, double-blind, dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. RECONNECT met its primary endpoint, demonstrating a clinically-meaningful reduction in MADRS scores through Day 28, as well as a favorable safety and tolerability profile.
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Source: Reunion Neuroscience, Inc.
