Neumora halted one trial of its depression drug navacaprant and paused a pair of late-stage studies as it tries to learn from a recent phase 3 failure.
The KOASTAL-1 study, which read out in January, showed that changes on a depression rating scale were exactly the same among patients who received the oral kappa opioid receptor antagonist and those who received placebo after six weeks of daily dosing.
Neumora said this morning that it has since conducted “extensive analyses to identify factors that might have contributed to the study outcome.”
“These analyses suggested that further optimizing site selection and enhancing medical monitoring are required to help ensure the appropriate patients are enrolled in the KOASTAL program moving forward,” the biotech explained.
As a result, Neumora has paused its KOASTAL-2 and -3 trials while it makes a number of changes, including limiting the number of trial sites to those that “we believe have the greatest level of expertise in conducting MDD studies.”
The company’s medical team will also increase its efforts to ensure only eligible patients are signed up to the trials by coordinating with the Massachusetts General Hospital Clinical Trials Network and Institute's “SAFER” approach to reviewing patients.
Finally, Neumora plans to strengthen its existing patient screening process by adding the Verified Clinical Trial screening database. This should help avoid patients being enrolled onto the KOASTAL studies if they are already participating in another clinical trial.
The company is banking on these amendments being made in time to resume KOASTAL-2 and -3 later this month. The timelines for both trials have now been pushed back, with Neumora expecting KOASTAL-3 to read out in the first quarter of 2026, while KOASTAL-2 follows in the quarter after. Despite the delay, both readouts should still be covered by the $307.6 million that Neumora currently has in the bank.
A phase 2 trial of navacaprant in bipolar depression won’t be so lucky. Neumora said today that it is discontinuing that study “to prioritize the resources allocated to navacaprant on the KOASTAL program.”
“The company continues to believe that navacaprant may offer benefit for treating bipolar depression and will evaluate opportunities to investigate it in this indication in the future,” Neumora added.
The changes run all the way up to the C-suite, where Neumora’s head of R&D Robert Lenz, M.D., Ph.D., is leaving “to pursue other interests.” Lenz will continue to have an advisory role at the company, the biotech said. Last month, CEO Henry Gosebruch left the company to be replaced by co-founder and executive board chair Paul Berns.