Reunion Neuroscience Inc. (NASDAQ: REUN / TSX: REUN), a clinical-stage biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, announced today that the Company’s first-in-human results for lead asset, RE104, have been accepted for a poster presentation at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place on May 30 through June 2 in Miami. Dr. Robert Alexander, Reunion’s Chief Medical Officer, will share the findings on RE104, a proprietary, novel serotonergic psychedelic being developed as a potential fast-acting and durable treatment for patients suffering from postpartum depression (PPD) and other mental health conditions.

Previously reported key takeaways from the interim dataset from the Phase 1 study include:

  • RE104 was shown to be safe and well tolerated, with no serious or severe adverse events.
  • RE104 showed robust and pervasive pharmacodynamic effects with a shorter duration of psychedelic experience relative to published data with psilocybin (approximately three to four hours for RE104 versus six to eight hours for psilocybin).
  • Reunion identified a dose level where participants receiving a single administration of RE104 achieved a quality pharmacodynamic response that, in other psychedelic treatment trials, has been shown to correlate with therapeutic response for patients with depression, anxiety and substance use disorder.

“For the first time, Reunion will be presenting data from all six cohorts of our Phase 1 clinical trial results, along with our anticipated Phase 2 clinical trial plans, at the ASCP Annual Meeting. The standard of care available to new moms suffering from PPD is unacceptable. PPD affects one in eight mothers and is believed to be a significant contributing factor to rising maternal death rates. As the only psychedelic asset in the clinic targeting the PPD indication in the U.S., single-dose RE104 could potentially provide mothers with fast-acting symptom relief and a quick return to essential mother-child bonding and breastfeeding. We look forward to presenting these promising results as we continue to advance RE104 in the clinic.”

Greg Mayes, President and CEO, Reunion Neuroscience

A total of 48 subjects across all six cohorts have now completed study drug administration and will be included in the final analysis of safety, pharmacokinetics and pharmacodynamics.

About Reunion Neuroscience Inc.

Reunion is committed to developing innovative therapeutic solutions for underserved mental health conditions. The Company’s lead asset, RE104, a proprietary, novel, serotonergic psychedelic compound and the only 4-OH-DiPT prodrug in clinical development, is being developed as a potential treatment for postpartum depression that could provide rapid symptom relief and durable efficacy. RE104 is protected under U.S. Patent No. 11,292,765 issued on April 5, 2022 (priority June 30, 2020), with claims for composition of matter, methods of manufacturing, formulations and methods of use for a genus of hemi-ester tryptamines, including RE104, which could provide protection out to June 30, 2041. Reunion is also developing the RE200 series, which includes preclinical compounds with enhanced receptor selectivity to address additional therapeutic applications.