Reunion Neuroscience Inc. announced that company expects to start enrolling patients this quarter in the RECONNECT Trial, a Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active Dose-Controlled study evaluating RE104 in moderate and severe PPD patients (NCT06342310). Results from the RECONNECT Trial are expected in Second Quarter 2025. PPD is a form of major depression that is estimated to affect about 10-15% of all mothers of newborns.

The leading underlying cause of pregnancy-related death, accounting for 23% of pregnancy-related death, is mental health conditions. This includes deaths due to suicide and overdose/poisoning related to substance use disorder (Centers for Disease Control and Prevention [CDC], 2022). 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. Reunion is actively investigating the use of RE104 in additional neuropsychiatric indications, including adjustment disorder in cancer (ADC), where there remains a significant unmet need that is not addressed by the current standard of care. ADC is a maladaptive response to a cancer diagnosis persisting for longer than two weeks that is considered disproportionate to the magnitude of the stressor.

It is estimated that 40% of cancer patients develop a mood disorder. RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. RE104 targets the serotonin 2A receptor (5HT2AR), which is the recognized target for the antidepressant effects of psychedelic compounds.

As psychedelic drugs require monitoring by trained healthcare providers, per recent FDA Guidance (June 2023), Reunion designed RE104 to deliver a short duration psychedelic experience and require only about half a day in-clinic, a significantly shorter time commitment than required for longer duration psychedelics, like psilocybin and MDMA. 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.