Softbank, Amgen-Backed Neumora Therapeutics Unveils Plans For Three Phase 3 Studies For Major Depressive Disorder

Neumora Therapeutics unveiled plans for three late-stage studies for its major depressive disorder (MDD) candidate Navacaprant.

The U.S.-based clinical-stage biopharmaceutical is backed by Softbank Group Corp SFTBY SFTBF and Amgen Inc AMGN via a $100 million equity investment.

Neumora's KOASTAL Phase 3 program, comprising three Phase 3 studies, is designed to evaluate 80 mg of the once-daily navacaprant (NMRA-140) oral monotherapy for MDD. 

The U.S. trial, the KOASTAL-1 study, is expected to be initiated in 3Q23, with the KOASTAL-2 study in U.S., Canada, and Latin America in Q4 2023 and the KOASTAL-3 study in 1Q24. The study will be conducted in the U.S., Asia Pacific, and Europe. 

The planned initiation follows the successful completion of an End-of-Phase 2 meeting with the FDA and a robust Phase 2 study with navacaprant. 

The experimental drug navacaprant helped reduce symptoms of depression in patients with moderate-to-severe forms of the disorder in a mid-stage trial.

Neumora's navacaprant reported drops of 3.0 at week four and 2.8 at week eight on the 17-item Hamilton Rating Scale for Depression, with p-values of 0.015 and 0.037, respectively, for moderate-to-severe patients.

Neumora hired Henry Gosebruch as president and CEO. Gosebruch, AbbVie Inc's former chief strategy officer, succeeds Paul Berns, who transitioned to executive chair.