Reunion Neuroscience has announced promising new results from its Phase 2 RECONNECT clinical trial. The company’s new drug, RE104, could provide fast and sustained relief for women struggling with postpartum depression (PPD).
“PPD remains the most common complication of pregnancy and childbirth in the [United States], affecting approximately 15% of new mothers within the first year after giving birth, with nearly 500,000 women… diagnosed annually,” the trial’s lead investigator, Anita H. Clayton, MD, said.
Compelling Numbers
The study tested a single subcutaneous dose of RE104 in 84 adult women with moderate-to-severe PPD across more than three dozen U.S. sites. Results showed that the higher 30 mg dose produced a 23-point drop on the Montgomery-Åsberg Depression Rating Scale (MADRS) after one week. That was 5.8 points greater than the drop researchers recorded with the control dose of 1.5 mg, a statistically significant difference (p=0.0094).
Some striking clinical response and remission rates stood out.
- By day 7, 77% of women receiving 30 mg of RE104 showed at least a 50% reduction in symptoms.
- While 71% met the threshold for remission, with a MADRS score of 10 or lower.
Both measures persisted through the 28-day follow-up period.
Patients also reported rapid relief. Researchers noted clinically meaningful reductions in depression scores as soon as 24 hours in some patients. That marks a stark departure from so many conventional antidepressants that can take weeks to make any identifiable difference.
Scores on the Barkin Index of Maternal Functioning echoed these results.
A Safer Way Forward?
“Current therapies can be slow to act and burdensome, leaving many mothers without timely care,” Clayton, who’s also the chair of psychiatry at the University of Virginia, said. “These findings highlight RE104’s potential to deliver quick, safe relief in a single injection, minimizing disruption during a critical time for mothers and infants.”
The safety data the study produced appeared to be just as encouraging. The researchers noted that RE104 was generally well tolerated, with the most common side effects being mild-to-moderate nausea (44%) and headaches (34%). These typically cleared up within the day of treatment. The team also reported no serious adverse events, suicidal ideation, seizures, or serotonin toxicity..
Notably, clinicians cleared 92.7% of the participants for discharge within four hours of dosing — a crucial consideration given the new caregiving responsibilities that these patients bear.
Reunion also released preliminary results from a lactation study, which found that only a tiny fraction of RE104 metabolites appeared in breast milk — less than 0.1% of the administered dose. Company officials believe this could allow women to resume breastfeeding with very little disruption.
“This therapy could help more mothers find their way back to themselves and their families for the moments that matter most,” trial investigator Camille Hoffman, MD, professor of maternal-fetal medicine at the University of Colorado, added.
What’s Next?
Looking ahead, Reunion executives plan to launch a pivotal Phase 3 trial in 2026 to further evaluate RE104 in PPD.
Company officials are also prepping a Phase 2 study of the drug for adjustment disorder related to cancer, along with tests for other psychiatric conditions.
Reunion’s chief medical officer, Mark Pollack, called the Phase 2 results “strong clinical validation” for the drug’s potential to deliver quick relief for new mothers.
“We believe RE104 has the potential to redefine the standard of care for debilitating disorders such as PPD and adjustment disorder,” he said.
Further Reading
RE104 Offers a Revolutionary Approach to Postpartum Depression
Hormonal Contraception Use May Help Predict Postpartum Depression
