Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33

Neumora Therapeutics is making big moves this week. On Tuesday the young biotech announced the initiation of a Phase III program for its potential depression treatment along with a new CEO to lead the way.

The nearly two-year-old startup posted statistically significant results for treating moderate-to-severe major depressive disorder (MDD) in its Phase II trial of navacaprant, a kappa opioid receptor (KOR) antagonist. Initiated by BlackThorn Therapeutics prior to its acquisition by Neumora, the trial was amended to include those more serious MDD patients, the population in which it appears to be most effective.

In moderate-to-severe patients, navacaprant had statistically significant results in lowering patients’ 17-item Hamilton Rating Scale for Depression score by 3 points at week 4 and 2.8 points by week 8. Across all patients, which included mildly depressed patients, navacaprant did not achieve statistical significance compared to placebo at week 8.

After meeting with the FDA, Neumora is moving forward with a slate of Phase III studies focused on moderate-to-severe MDD patients. The biotech will launch a study each quarter, beginning in Q3, for three quarters. An open label extension will also commence to determine long-term safety. If successful, these studies are expected to support a New Drug Application in 2025, the company stated.

The potential differentiator for navacaprant is its management of anhedonia, the reduced ability to experience pleasure that around 70% of MDD patients experience. At 8 weeks, patients with moderate-to-severe MDD had a 4.8-point improvement on anhedonia symptoms on the Snaith-Hamilton Pleasure Scale. According to Neumora, research suggests anhedonia is a core risk factor for suicidal ideation and therefore an important symptom to address in patients.

The KOR antagonist was well-tolerated with treatment-emergent adverse events lower than those on the placebo—35.3% versus 44.1% in the placebo group. No suicidal behavior was identified for those on navacaprant, suggesting the treatment could avoid a risk of the SSRIs commonly prescribed in those with depression. The drug was not associated with sexual dysfunction or weight gain, also common problems of antidepressants.

Neumora was number one on BioSpace’s Top Life Science Startups to Watch list for 2023. The biotech attracted some big-name investors for a $400M Series A in October 2021, followed by a $112M Series B a year later.

Now the company is bringing in a seasoned leader to take over for co-founder Paul Berns as he transitions to executive chairman. Henry Gosebruch is stepping in as the new president and CEO. Gosebruch comes in from more than seven years as a member of AbbVie’s C-suite making partnership and M&A deals for the big pharma.

With navacaprant at the forefront, the company pipeline is stocked with psychiatric and neuro-degeneration candidates including potential treatments for Alzheimer’s, PTSD/anxiety, schizophrenia, Parkinson’s and ALS.

It won’t be without a little competition, though. Johnson & Johnson’s Janssen also has a KOR antagonist in Phase III trials. Aticaprant is currently being tested as an adjunctive therapy to a current antidepressant in MDD patients with a focus on treating anhedonia. Studies are expected to be completed in mid-to-late 2024 and 2025.

Source: bioSpace.com