Reunion Neuroscience Inc. Announces First Patient Dosed in Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression
2024年7月23日 - 8:30PM
Reunion Neuroscience Inc., a clinical-stage biopharmaceutical
company committed to pushing the boundaries of neuroscience, today
announced that the first patient has been dosed in the RECONNECT
Phase 2 clinical trial of RE104 for the treatment of postpartum
depression (PPD). RE104 was designed to be a safe, fast-acting,
single-dose therapy to benefit patients suffering from underserved
mental health disorders, including PPD.
“Dosing the first patient in our RECONNECT Phase
2 trial represents an important step forward in our mission of
improving the lives of patients and families impacted by PPD,” said
Greg Mayes, President and Chief Executive Officer of Reunion.
“There is a clear need for fast-acting, single-dose treatments with
durable efficacy for PPD patients. Reunion is committed to serving
not only the unmet need in PPD, but also the broader community
affected by mental health disorders through its development
programs.”
The RECONNECT Phase 2 clinical trial
(NCT06342310) is a multicenter, randomized, double-blind,
parallel-group, active dose-controlled clinical trial evaluating
the safety and efficacy of a single subcutaneous dose of RE104 in
adult female patients with moderate-to-severe PPD. The primary
endpoint of the trial is the change in total Montgomery-Åsberg
Depression Rating Scale (MADRS) score, a 10-item clinician rated
scale measuring depression severity from baseline, at Day 7. Key
secondary endpoints include the change in total MADRS score
from baseline at Day 1, 14 and 28, MADRS response
indicating a ≥ 50% reduction in symptoms, MADRS remission with a
score of ≤ 10, as well as safety and tolerability.
About RE104 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 is
actively evaluating the use of RE104 in additional neuropsychiatric
indications, including adjustment disorder in cancer patients,
where there remains a significant unmet need that is not addressed
by the current standard of care.
About Postpartum Depression
(PPD)Postpartum depression (PPD) is one of the most common
medical complications during and after pregnancy and is estimated
to affect approximately 10-15% of all mothers of newborns. PPD is a
form of major depression that can severely impact women and their
families. According to the Centers for Disease Control and
Prevention, the leading underlying cause of pregnancy-related death
during the first postpartum year are due to mental health
conditions, with suicide being the leading manner of death. 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. We believe there is a significant unmet need for a
solution that offers a faster onset of action, greater efficacy
after only a single dose, with a fast return to normal daily
activities.
About Reunion Neuroscience
Inc.Reunion Neuroscience is committed to pushing the
boundaries of neuroscience to develop innovative therapeutic
solutions for postpartum depression (PPD) and other underserved
mental health disorders. In August of 2023, Reunion Neuroscience
became a private company as part of the MPM BioImpact portfolio and
in May 2024, the Company completed a $103 million Series A
financing co-led by MPM BioImpact and Novo Holdings. Reunion is
actively investigating the use of its lead product candidate,
RE104, in PPD, as well as in additional neuropsychiatric
indications, including adjustment disorder in cancer, 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:Courtney
MogerleyPrecision AQcourtney.mogerley@precisionaq.com
PR Inquiries:Ashley Murphy
Precision AQashley.murphy@precisionaq.com