Neumora Therapeutics’ big bet on a new era of neuroscience has delivered an age-old result. The first of three late-stage readouts on Neumora’s lead drug candidate has ended in failure, wiping more than 80% off the value of the biotech.
Arch Venture Partners set up Neumora in the belief advances in genomics and neurobiology had set the stage for a more targeted—and less risky—approach to neuroscience R&D. The VC shop rolled up several biotechs to create Neumora and led a syndicate that pumped an initial $500 million into the startup. A deal with Amgen, a second private round and an IPO added almost $500 million more to the coffers.
This morning, investors learnt what their cash has delivered—and were unimpressed with the results. The biotech reported data from KOASTAL-1, the first of three phase 3 trials of navacaprant in major depressive disorder.
Investigators randomized 383 people to receive the oral kappa opioid receptor antagonist or placebo. After six weeks of daily dosing, scores on a depression rating scale had fallen 12.5 points in the navacaprant cohort. The problem? Scores also fell 12.5 points in the placebo arm, causing the trial to miss its primary endpoint.
The bad news was compounded by the failure of a key secondary endpoint that evaluated changes in the ability of patients to feel pleasure. Scores fell 5.8 points on the Snaith-Hamilton Pleasure Scale in people taking navacaprant versus a 5.5-point reduction in their counterparts on placebo.
Even so, Neumora CEO Henry Gosebruch noted “encouraging trends in the data” in a statement about the readout. The trends include a disconnect between how navacaprant performed in men and women, with the results favoring navacaprant in the 105 female patients.
On the depression scale, the navacaprant and placebo reductions were 14 and 11.4 points, respectively. The reductions on the pleasure scale were 7.2 points for navacaprant and 4.9 points for placebo. The flip side of that case for navacaprant is that placebo performed numerically better than navacaprant in men. Women made up a smaller portion of participants in KOASTAL-1 than in Neumora’s phase 2 trial.
Neumora’s press release lacks an explanation for why navacaprant would perform better in women than in men. More details may emerge when Neumora presents at the J.P. Morgan Healthcare Conference later this month. For now, investors are taking little solace from Neumora’s talk of encouraging trends, driving the stock down more than 80% to below $2 in premarket trading.