Navacaprant was invented at Scripps Research in the laboratories of faculty members Edward Roberts, PhD (left), and Hugh Rosen, MD, PhD (right).
Major depressive disorder therapy to enter Phase 3 pivotal clinical trials
Navacaprant, a monotherapy discovered at Scripps Research, showed clinically meaningful improvements for people with moderate-to-severe MDD in a recently completed Phase 2 study.
July 21, 2023
LA JOLLA, CA — The drug navacaprant, also known as NMRA-140, will be entering a Phase 3 pivotal clinical program to evaluate its safety and efficacy for the treatment of major depressive disorder (MDD). Navacaprant was initially discovered at Scripps Research and is currently being developed by spin-off company Neumora Therapeutics (formerly BlackThorn Therapeutics).
Navacaprant was invented at Scripps Research in the laboratories of faculty members Edward Roberts, PhD, and Hugh Rosen, MD, PhD. Navacaprant has a novel mechanism of action that works by blocking the brain’s kappa opioid receptors, which play a key role in many different central nervous processes—including stress, mood, pain, inflammation and more. NRMA-140 was designed to reduce the body’s stress response and mediate negative emotions, which holds the potential to improve cognitive impairment and ease symptoms of a depressed mood.
“Depression has emerged as a leading global health concern, taking an immense toll on individuals and their loved ones,” says Rosen, professor in the Department of Molecular Medicine at Scripps Research and co-founder of BlackThorn Therapeutics. “As evidenced in the recently completed Phase 2 studies, navacaprant has a novel mechanism of action, meaning it is differentiated from other antidepressants currently available today. As navacaprant is set to enter pivotal clinical trials in the near future, this monotherapy is that much closer to reaching those who are in severe need of new therapeutics.”
Roughly 21 million adults in the United States have reported experiencing a major depressive episode, which represents 8.4% of all U.S. adults. Females are more likely to experience major depression, and people ages 18-25 are the most affected. The National Survey on Drug Use and Health (NSDUH) defines a major depressive episode as “a period of at least two weeks when a person experienced a depressed mood or loss of interest in pleasure in daily activities, and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration or self-worth.”
Neumora is initiating its Phase 3 clinical program after a recently completed Phase 2 study showed clinically meaningful improvements in depression symptoms for people with moderate-to-severe MDD who took navacaprant, as well as a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The pivotal program will include three Phase 3 randomized, placebo-controlled, double-blind studies. It will also incorporate an open-label extension study designed to evaluate the long-term safety of navacaprant. These studies are expected to support a New Drug Application (NDA) for navacaprant’s use as a monotherapy in 2025.
For more information, contact press@scripps.edu