Oral monotherapy for major depressive disorder entering phase 3 trials

Key takeaways:

• Trials will evaluate the safety and efficacy of a monotherapy for major depressive disorder.
• The drug significant and meaningful reductions in depression and anhedonia symptoms.

monotherapy for the treatment of major depressive disorder, is set to enter a phase 3 clinical program, with a new drug application expected in 2025, according to a press release.

The phase 3 programcalled KOASTALwill test navacaprant’s safety and efficacy starting this year, Neumora . follows a phase 2 trial where participants with moderatetosevere major depressive disorder in symptoms including anhedonia.

“These symptoms are among the most challenging to treat and cause significant negative impact on patients’ quality of life,” Paul L. Berns, Neumora’s co-founder and executive chairman, said in the release. “Patients deserve better treatment options for depression, and we are working with urgency to address the serious unmet medical need that remains.”

Navacaprant is intended as an oral monotherapy for major depressive disorder at a dosage of 80 mg once daily. It is a novel, highly selective antagonist of the kappa opioid receptor, which is part of a “well-characterized pathway known to mediate depressive-like states,” the release stated.

The phase 3 KOASTAL program consists of four studies. Navacaprant’s efficacy will be tested in three randomized, placebo-controlled, double-blind studies across the U.S., Canada, Latin America, Europe and Asia Pacific region. Following those studies, participants can enroll in an open-label extension study, KOASTAL-LT, evaluating the drug’s long-term safety.

Neumora expects the studies to support a new drug application for monotherapy in 2025.

Treatment-emergent adverse events affected 35.3% of people in the navacaprant group. Most events were mild to moderate, and none were severe. There was no association with sexual dysfunction, weight gain or suicidal behavior.

Roger S. McIntyre, MD, FRCPC, professor of psychiatry and pharmacology at the University of Toronto, said in the release that phase 2 results were “compelling” and that he is “excited that these benefits will be further studied in the global phase 3 KOASTAL program.”