The article Reunion Neuroscience Completes Data Analysis for Phase 1 Clinical Trial was originally published on Microdose.
Reunion Neuroscience Completes Interim Data Analysis for Phase 1 Clinical Trial with Novel Serotonergic Psychedelic RE104
First-in-Human Findings Highlight RE104’s Strong Safety and Differentiated Pharmacodynamic Profile, Setting Stage for Initiation of Phase 2 Development in Postpartum Depression
TORONTO, Jan. 09, 2023 (GLOBE NEWSWIRE) — Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN) (“Reunion” or “the Company”), a biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, today announced that the Company has completed the interim data analysis for its Phase 1 clinical trial with lead asset RE104, a unique 4-OH-DiPT prodrug. RE104 is a proprietary, novel serotonergic psychedelic compound that Reunion is developing as a potential fast-acting and durable treatment for patients suffering from postpartum depression and other mental health conditions.
In this first-in-human, Phase 1 study, RE104 was shown to be safe and well tolerated, with no serious or severe adverse events. The interim analysis included 32 healthy volunteers across four ascending dose cohorts, with two of the eight subjects in each cohort receiving placebo. 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).1-2
Reunion also identified a dose level whereby the majority of participants receiving a single administration of RE104 achieved a “complete mystical experience,” defined as a score of at least 60 percent in each of the four domains of the validated Mystical Experience Questionnaire (MEQ30). A complete mystical experience has been shown to correlate with psychedelic treatment responses in clinical trials of patients with depression, anxiety and substance use disorder.3-5
Reunion plans to share results from its Phase 1 study with the U.S. Food and Drug Administration (FDA) as part of a pre-Investigational New Drug (IND) meeting in preparation for Phase 2 development in postpartum depression. The Company will also submit the data to an upcoming 2023 major medical congress.
While completing the preplanned interim analysis, and per the recommendation of the Safety Review Committee (SRC), Reunion has continued with dose escalation and initiated a fifth cohort. The Phase 1 protocol also includes the option to dose a sixth cohort with eight subjects should the SRC or the Company seek additional safety, pharmacokinetics and pharmacodynamics data.
“We are extremely encouraged by the interim data from our Phase 1 clinical trial, as we’ve been able to identify a dose at which most participants had a short-duration, but complete, mystical experience without any serious or severe adverse events,” said Greg Mayes, President and CEO, Reunion Neuroscience. “We are confident that this data provides robust justification for selecting a dose of RE104 that could yield clinical efficacy in the treatment of postpartum depression.”
Mr. Mayes continued, “Innovation in the development of mental health treatment is severely lacking and has failed to provide meaningful change in how we approach these all-too-common conditions, especially with respect to women’s mental health. We are eager to introduce a new psychedelic compound with significant potential advantages for these patients. The Company looks forward to unveiling the full Phase 1 dataset in the first half of 2023 and will continue to forge ahead in our mission to transform mental health treatment for the millions of people suffering worldwide.”
About Reunion Neuroscience Inc.
Reunion is committed to developing innovative therapeutic solutions for underserved mental health conditions. The Company’s lead asset, RE104, is a proprietary, novel serotonergic psychedelic compound being developed as a potential fast-acting and durable treatment for patients suffering from postpartum depression and other mental health conditions. The U.S. Patent and Trademark Office has granted the Company a patent for the claims related to RE104, granting it exclusive rights to the composition of matter, use and manufacturing of a family of hemi-ester compounds of hydroxytryptamines, including RE104. The patent will provide protection until 2041. Reunion is also developing the RE200 series, which includes compounds with potential for more selective serotonin receptor activity with reduced psychoactivity for potential use in more chronic treatment paradigms and indications.