Fluence and Reunion Neuroscience Inc. Announce Partnership on Phase 2 Clinical Study of RE104 for Postpartum Depression

Study monitors to be trained on Fluence platform

NEW YORK, April 15, 2024 /PRNewswire-PRWeb/ -- Fluence, a global leader in education, training, and certification for practitioners of psychedelic medicine, and Reunion Neuroscience Inc., a venture backed clinical-stage biopharmaceutical company committed to pushing the boundaries of neuroscience, today announced a strategic partnership to support the Phase 2 clinical study evaluating the safety and efficacy of RE104 in postpartum depression (PPD). Fluence will bring its expertise to Reunion Neuroscience's study monitors, ensuring the highest standards of therapeutic support and rigorous, scalable training within the clinical trial context.

Reunion's lead asset, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, a psilocybin-like compound. In a Phase 1 study, RE104 produced a psychedelic, psychoactive state similar in intensity and quality to psilocybin, but lasting only about half the time (3-4 hours) while demonstrating a similar, favorable safety profile. Reunion is evaluating RE104 in patients with underserved mental health disorders, beginning with PPD (NCT06342310).

Under the partnership, Fluence will provide comprehensive support for Reunion Neuroscience's Phase 2 clinical trial by delivering an updated study monitor manual, creating custom training videos, hosting and administering the training program through their learning management system, and training study monitors using a combination of asynchronous learning and live-online sessions.

"We are thrilled to partner with Reunion Neuroscience in their groundbreaking study on RE104 for postpartum depression," said Dr. Elizabeth Nielson, Co-founder and Chief Visionary Officer at Fluence. "By leveraging our expertise in psychedelic therapy training within the clinical research environment, we aim to support Reunion Neuroscience in conducting a rigorous and successful clinical trial, ultimately contributing to the advancement of this innovative treatment for postpartum depression."

"This partnership with Fluence is a significant step towards our goal to meaningfully transform mental health treatment for the many patients underserved by the treatment paradigm available under current standard of care," said Greg Mayes, President and Chief Executive Officer of Reunion. "The addition of Fluence's expertise in our Phase 2 clinical study of RE104 supports our commitment to uphold the highest standards throughout our trials to ensure patient safety is prioritized. We look forward to collaborating with Fluence, a leader in providing education, training, and certification for practitioners prescribing psychedelic medicine, as we explore the potential of RE104 as an improved treatment option for patients with PPD."

PPD is a form of major depression that is estimated to affect about 10-15% of all mothers of newborns. Women suffering from PPD often experience significant changes in mood, appetite and sleep contributing to feelings of hopelessness, lack of concentration, loss of energy, poor self-esteem and maternal disinterest. While there have been recent developments in treatment options for PPD, there continues to be a significant unmet need for a solution that offers improved safety and tolerability, a faster onset of action, greater efficacy after only a single dose, with limited interruption in breastfeeding and a faster return to normal daily activities.

About Fluence

Fluence is the global leader in providing comprehensive, evidence-based training in psychedelic therapy and integration to healthcare professionals. With a mission to equip clinicians with the clinical skills and knowledge necessary for effective, evidence-based psychedelic therapy and integration services, Fluence offers ethical, dynamic, interactive training both online and in-person. Since its inception, Fluence has educated over 7,000 practitioners, establishing itself as a frontrunner in psychedelic therapy training for private enterprises and research organizations.

About Reunion Neuroscience Inc.

Reunion Neuroscience is committed to pushing the boundaries of neuroscience to develop innovative, patented, FDA-approved serotonergic psychedelic therapeutic solutions for postpartum depression (PPD) and other underserved mental health disorders. The Company's lead asset, RE104, a proprietary, potential best-in-class, serotonergic psychedelic compound and the only 4-OH-DiPT prodrug in clinical development, is being evaluated as a potential treatment for postpartum depression, (NCT06342310), that could provide rapid symptom relief and durable efficacy. Reunion is actively investigating the use of RE104 in additional indications susceptible to being treated with a 5HT2A agonist molecule.

Media Contact

Brad Burge, Fluence, 1 6508636887, [email protected], https://www.fluencetraining.com

SOURCE Fluence