Reunion Neuroscience Reports Earnings, Update on Postpartum Drug Study

“This was a transformative quarter for Reunion. We enter 2023 well-positioned with both encouraging clinical data and a highly experienced executive leadership team in place to execute on our mission to rapidly and efficiently develop RE104 as a potential therapeutic option for the millions of patients underserved by today’s standard of care in depression and other mental health disorders,” said Greg Mayes, President and Chief Executive Officer, Reunion. “We recently announced our first-ever clinical data where RE104 showed encouraging pharmacokinetic, pharmacodynamic, and safety data. The analysis included a dose that demonstrated the short-duration and robust pharmacodynamic effects we believe are needed for clinical efficacy in Phase 2.”

Reunion reported general and administrative expenses of $3.1 for the quarter versus $4.6 in the same period in 2021. Changes included increased costs attributable to increased headcount and other costs associated with becoming a public company with an increased scale of operations due to the company entering the clinical stage for its lead asset RE104.

Reunion said that it continues to advance its serotonergic psychedelic compound called RE104 through the clinic as a potential fast-acting, durable treatment for patients suffering from PPD (postpartum depression). The company said in a statement that one in eight mothers experience PPD, and there remains only one FDA-approved treatment for the condition, which is administered by continuous infusion over a 60-hour inpatient hospital stay and has a black box safety warning due to excessive sedation and potential for sudden loss of consciousness.

As a novel serotonergic psychedelic, single-dose RE104 could potentially provide mothers with fast relief and a quick return to mother-child bonding and breastfeeding (an estimated 24 to 48 hours) due to RE104’s limited-duration psychoactive experience (less than four hours), durable efficacy and rapid washout period. This compares favorably to psilocybin treatments that can last six to eight hours.

In January 2023, Reunion reported that it had completed its Phase 1 interim data analysis, which showed that RE104 was 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 a placebo. RE104 demonstrated 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).

After completing the preplanned interim analysis, and per the recommendation of the Safety Review Committee, Reunion continued with dose escalation to seek additional safety, pharmacokinetic and pharmacodynamic data. Exploring further doses with the two additional planned cohorts will provide Reunion with valuable data to inform the selection of a recommended Phase 2 dose.

Reunion also reported that it has submitted the Phase 1 data to an upcoming 2023 medical congress and to the FDA in preparation 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 expected that the multicenter trial will enroll approximately 40 patients from 20 centers across North America.