Reunion Neuroscience Inc. has announced the completion of patient dosing in its Phase 2 RECONNECT clinical trial, evaluating the efficacy and safety of RE104 (isoprocin hydrobromide) for the treatment of postpartum depression (PPD). This milestone marks a significant step forward in the company's development of novel serotonergic psychedelic compounds for mental health conditions.
The RECONNECT trial, a randomized, double-blind, placebo-controlled study, has enrolled 40 patients across multiple clinical sites in the United States. Participants received either a single 35mg dose of RE104 or placebo, with comprehensive psychological support provided before, during, and after treatment.
"Completing the dosing phase of our RECONNECT trial represents an important advancement in our clinical development program for RE104," said Greg Mayes, President and CEO of Reunion Neuroscience. "We are eager to analyze the data and share topline results, which we expect in the fourth quarter of this year."
About RE104 and Its Potential Impact
RE104, also known as isoprocin hydrobromide, is a proprietary, New Chemical Entity (NCE) that acts as a serotonergic psychedelic compound. It is the prodrug of 4-OH-DiPT, a psychedelic tryptamine that primarily binds to 5-HT2A receptors.
The compound has demonstrated several potential advantages in preclinical studies, including a faster onset of action (10-20 minutes) and shorter overall duration of psychedelic experience (2-3 hours) compared to many other psychedelic treatments. These characteristics could make RE104 more practical for clinical use and potentially reduce the resource intensity typically associated with psychedelic therapy sessions.
Dr. Sarah Johnson, Chief Medical Officer at Reunion Neuroscience, explained: "RE104's pharmacokinetic profile may offer significant advantages for patients and healthcare providers. The shorter duration could improve accessibility while maintaining therapeutic efficacy, potentially addressing one of the key limitations of current psychedelic treatment approaches."
Addressing the Unmet Need in Postpartum Depression
Postpartum depression affects approximately 1 in 8 women who give birth in the United States, representing a significant public health challenge. Current treatment options, including standard antidepressants, often require weeks to take effect and may not be suitable for all patients, particularly breastfeeding mothers.
The RECONNECT trial aims to evaluate whether RE104 can provide rapid and durable relief from PPD symptoms. The study's primary endpoint is the change from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score at Day 8 post-dose, with multiple secondary endpoints assessing durability of effect up to 4 weeks.
"Postpartum depression can have devastating effects on mothers, infants, and families," noted Dr. Emily Roberts, a reproductive psychiatrist not affiliated with the trial. "Novel treatment approaches that could provide rapid relief would represent a significant advancement in care for this vulnerable population."
Trial Design and Next Steps
The RECONNECT trial employed a rigorous methodology to assess RE104's efficacy and safety. Beyond the primary endpoint at Day 8, the study will track outcomes at Days 15 and 29 to evaluate the durability of treatment effects. Safety assessments, including monitoring of vital signs and adverse events, were conducted throughout the trial.
All participants received preparatory sessions before dosing and integration sessions afterward, following established protocols for psychedelic-assisted therapy. This comprehensive approach aims to maximize the potential therapeutic benefit while ensuring patient safety.
With patient dosing now complete, Reunion Neuroscience will proceed with data analysis. The company has indicated that topline results are expected in Q4 2023, with complete study results to follow.
"The completion of dosing in our Phase 2 trial brings us one step closer to potentially offering a novel treatment option for women suffering from postpartum depression," added Mayes. "We look forward to analyzing the results and determining next steps in the development program."
If successful, RE104 could join a small but growing number of psychedelic-based treatments advancing through clinical development for various mental health conditions. The company has indicated that positive results could lead to further studies exploring RE104's potential in other indications where rapid-acting antidepressant effects would be beneficial.
