Reunion completes interim data analysis for Phase 1 trial with RE104

Reunion Neuroscience announced that the Company has completed the interim data analysis for its Phase 1 clinical trial with lead asset RE104. 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. 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. 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. Reunion plans to share results from its Phase 1 study with the U.S. Food and Drug Administration as part of a pre-Investigational New Drug meeting in preparation for Phase 2 development in postpartum depression. The Company will also submit the data to an upcoming 2023 major medical congress.