Postpartum Depression Psychedelic Treatment Studied In Reunion's Phase 1 Trial

Reunion will present findings to the FDA.

Reunion Neuroscience Inc. (NASDAQ: REUN) reported that it has completed the interim data analysis for its Phase 1 clinical trial with its lead asset RE104, a unique 4-OH-DiPT prodrug treating postpartum depression. The 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.

 The study included 32 healthy volunteers across four ascending dose cohorts, with two of the eight subjects in each cohort receiving a placebo. The company said that 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). This was the first human, Phase 1 study, and RE104 was shown to be safe and well tolerated, with no serious or severe adverse events.

“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.”

Reunion said it 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.

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.

The company also said in a statement that while completing the preplanned interim analysis, and per the recommendation of the Safety Review Committee (SRC), it 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.

Mayes added, “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.”

 

Debra Borchardt

Debra Borchardt is the Co-Founder, and Executive Editor of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Master's degree in Business Journalism from New York University.


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