Patient Enrollment Ongoing in Phase 2 RECONNECT Trial of RE104 in Postpartum Depression (PPD); Topline Data Anticipated Mid-2025
Initiation of Phase 2 REKINDLE Trial of RE104 in Adjustment Disorder (AjD) Expected in Mid-2025
Advancing RE245, a Non-Psychedelic Serotonergic Neuroplastogen, through Preclinical Development
Company to Present at 8th Annual Neuroscience Innovation Forum on January 12, 2025 in San Francisco, CA
MORRISTOWN, N.J., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, today announced program updates and anticipated 2025 milestones. The Company also announced that Greg Mayes, President and Chief Executive Officer, will present a corporate overview and participate in a panel discussion entitled "Future of Psychedelics” at the 8th Annual Neuroscience Innovation Forum, taking place January 12, 2025 in San Francisco, CA.
"We are relentlessly committed to revolutionizing the treatment of mental health disorders, which impact millions of patients, families and caregivers,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. "Our initial efforts are focused on RE104, a differentiated psychedelic designed to offer safe, fast-acting relief for patients who suffer from postpartum depression, adjustment disorder and other mental health conditions underserved by current treatment options. As we enter 2025, we are particularly encouraged by recent progress across our PPD program, where we remain on-track to report topline clinical data from our Phase 2 RECONNECT trial mid-year. We are grateful to the patients and physicians who are supporting our study, and to the many nonprofit organizations across the country that are building better awareness of maternal mental health and increased support for pregnant and postpartum women.”
Mr. Mayes continued, "Also in 2025, we will continue to expand our pipeline, initiating clinical development of RE104 in adjustment disorder - a significant mental disorder for which there are no approved products - and progressing our second product candidate, RE245, through IND-enabling studies. We look forward to advancing both programs, as we aim to build an industry-leading pipeline of differentiated therapeutic solutions, which can deliver the full promise of psychedelic-inspired medicines to address the worldwide mental health crisis.”
Program Updates and Upcoming Milestones
RE104 is a proprietary, potential best-in-class, serotonergic neuroplastogen. RE-104 is designed as a single-dose psychedelic that offers a fast onset and shorter treatment duration, as well as reproducible pharmacokinetics. RE104 has potential across a variety of neuropsychiatric indications, including in PPD and AjD, where Reunion is focusing its initial clinical development efforts.
Postpartum Depression (PPD): PPD is the most common complication of pregnancy and childbirth, with perinatal mood and anxiety disorders affecting one in five perinatal individuals up to one year after childbirth.
- RE104 is currently being evaluated in RECONNECT, a Phase 2 clinical trial evaluating the safety and efficacy of two doses of RE104 (30 mg and 1.5 mg) in reducing depressive symptoms in adult female patients with moderate-to-severe PPD.
- Reunion expects to complete patient enrollment and report topline clinical data from the RECONNECT trial in mid-2025.
- Reunion plans to evaluate RE104 in REKINDLE, a Phase 2 clinical trial evaluating the safety and efficacy of two doses of RE104 (30 mg and 1.5 mg) in reducing depressive and anxiety symptoms in patients with cancer and other medical illnesses, who are diagnosed with AjD.
- Reunion expects to initiate the REKINDLE trial in mid-2025.
- Reunion plans to initiate investigational new drug (IND)-enabling studies for RE245 in 2025 and to file an IND application in 2026.
Reunion's President and Chief Executive Officer, Greg Mayes, will present a corporate overview and participate in a panel discussion, "Future of Psychedelics,” at the 8th Annual Neuroscience Innovation Forum being held on January 12, 2025 in San Francisco, CA. Details of the presentation and panel discussion are as follows:
- Presentation: 11:35 a.m. PT (2:35 p.m. ET)
- Panel Discussion: 2:20 p.m. PT (5:20 p.m. ET).
The Company's lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. Reunion designed RE104 to deliver a short duration psychedelic experience compared to longer duration psychedelics like psilocybin. In a Phase 1 clinical trial, RE104 produced a psychedelic 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. RE104 is currently being evaluated in the RECONNECT Phase 2 (NCT06342310) clinical trial, a multicenter, randomized, double-blind, active dose-controlled clinical trial in moderate-to-severe postpartum depression (PPD) patients. Reunion plans to initiate the REKINDLE Phase 2 clinical trial, a randomized, double-blind, parallel-group, dose-controlled trial in adjustment disorder (AjD) in cancer and other medical illnesses.
About RECONNECT
The RECONNECT Phase 2 clinical trial (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled clinical trial is evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. To learn more about the study and eligibility for enrollment, please visit www.ppdreconnectstudy.com.
About Reunion Neuroscience Inc.
Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In August of 2023, Reunion Neuroscience became a private company and in May 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression and adjustment disorder, as well as in additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. For more information about the company, visit https://reunionneuro.com.
For further information:
IR Inquiries:
Hannah Deresiewicz
Precision AQ
PR Inquiries:
Ashley Murphy
Precision AQ
