A potentially new kind of depression drug is heading into late-stage human testing after generating positive results among certain patients in a smaller study.
Neumora Therapeutics, the privately held biotechnology company developing the drug, announced those results Tuesday. The study found participants with moderate-to-severe major depressive disorder who were given Neumora’s treatment as opposed to a placebo experienced statistically significant, meaningful improvements in depression symptoms like anhedonia, or the inability to feel pleasure.
Neumora said its drug, called navacaprant, also provided some benefit to patients with mild depression. However, among these patients it didn’t hit the study’s main goal of improving depression significantly more than a placebo after eight weeks of treatment. The study enrolled 171 participants, of whom 100 had moderate-to-severe MDD.
With results in hand, Neumora had an “end-of-Phase 2” meeting with the Food and Drug Administration that the company described as successful. It’s now planning to initiate a Phase 3 program named “KOASTAL,” which will include three trials evaluating the safety and effectiveness of navacaprant in moderate-to-severe MDD.
The first of those trials will take place in the U.S. and is expected to begin before the end of September, Neumora said. The other two, which will be conducted in the U.S. as well as other countries, should initiate toward the end of this year and early next year, respectively.
Navacaprant is an oral, once-daily medication that works in a different way than currently available antidepressants. It’s meant to inhibit “kappa opioid receptors,” a type of protein that performs a variety of functions throughout the central nervous system, including mood regulation and response to stress.
Neumora said that, so far, its drug has been well-tolerated and shown a “favorable safety profile” compared to placebo. In the Phase 2 study, the incidence of treatment emergent adverse events was lower in the navacaprant group, at 35%, versus in the control group, at 44%. Most of these events were judged to be mild to moderate. No severe cases were reported among drug-treated patients.
Additionally, Neumora said navacaprant hasn’t been associated with sexual dysfunction or weight gain, which are common side effects with other antidepressants. There also hasn’t been evidence of suicidal behavior.
“The data from our Phase 2 study with navacaprant demonstrate its potential as a differentiated antidepressant that may help to manage anhedonia in addition to other core symptoms of depression,” said Paul Berns, Neumora’s co-founder and newly appointed executive chairman.
“These symptoms are among the most challenging to treat and cause significant negative impact on patients’ quality of life,” Berns added.
Alongside the trial updates, Neumora announced Tuesday that Henry Gosebruch is taking over for Berns as the company’s CEO. Gosebruch most recently served as chief strategy officer at AbbVie. Before that, he was co-head of J.P. Morgan’s North American M&A Group.
Berns and Gosebruch have worked together across their prior roles over the past decade or so, according to a Neumora spokesperson.
Neumora officially launched almost two years ago, supported by half a billion dollars in funding from Amgen and a slate of venture capital firms. Chief among those backers was Arch Venture Partners, which previously seeded another neuroscience startup, Blackthorn Therapeutics, as part of a broader aim to overcome some of the challenges plaguing brain drug development.
Navacaprant was Blackthorn’s drug until Neumora acquired the company. Ahead of its launch, Neumora also purchased a few other biotechs and licensed two preclinical assets from Amgen.
In October, the startup raised another $112 million from private investors.