Reunion Neuroscience provides 2023 corporate update

Reunion Neuroscience provided a corporate update for 2023 as it continues to advance its lead asset, RE104, through clinical development. As a proprietary, novel serotonergic psychedelic compound designed uniquely as a 4-OH-DiPT prodrug, RE104 is in development as a potential fast-acting, durable treatment for patients suffering from postpartum depression and other mental health conditions. Reunion plans to report a preplanned interim analysis on 32 subjects from its first-in-human Phase 1 trial for RE104 in Q1 2023. The study aims to address three important questions to differentiate RE104 from its therapeutic class: What is the safety and tolerability profile of this unique 4-OH-DiPT prodrug? What is the onset and duration of the psychoactive experience and pharmacokinetic profile of RE104 over a range of dose levels? and At what dose level of RE104 do most subjects achieve a "complete mystical experience" while maintaining an acceptable safety and tolerability profile? A complete mystical experience, as measured by the validated MEQ30, has been shown to correlate with a psychedelic treatment response in clinical trials of patients with depression, anxiety and substance use disorder 1-3. The Company plans to share detailed results from its Phase 1 study at a major medical meeting in the first half of 2023. The Company intends to include a review and discussion of the Phase 1 interim results in a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration intended for the first half of 2023. The output of the FDA meeting will support plans for initiating a randomized Phase 2 study evaluating RE104 versus placebo in the treatment of women with PPD in the second half of 2023. It is anticipated that the multicenter trial will enroll approximately 40 patients from 20 centers across North America. Once the PPD Phase 2 program is in progress, Reunion plans to share its continued RE104 development strategy in pursuit of treating additional indications. PPD represents a priority clinical development opportunity with a high unmet need for new therapeutic options. One in eight mothers experience PPD, and there remains only one FDA-approved treatment for the condition, which requires an inpatient hospital stay to support administration. Selective serotonin reuptake inhibitors are commonly prescribed for PPD, but they often take weeks to impart possible benefits, are not specifically approved for use in this setting and commonly require a trial of multiple SSRIs to find an effective solution. As a novel serotonergic psychedelic, single-dose RE104 could potentially provide mothers with fast relief and a quick return to breastfeeding due to the asset’s anticipated short psychoactive state, durable efficacy and rapid washout period. T.