Johnson & Johnson Stops Late-Stage Depression Study Over 'Insufficient Efficacy'

On Friday, Johnson & Johnson (NYSE:JNJ) decided to discontinue the Phase 3 VENTURA development program evaluating aticaprant, a kappa opioid receptor (KOR) antagonist, as an adjunctive treatment for major depressive disorder (aMDD).

The move follows insufficient efficacy in the target patient population. The data confirmed aticaprant is safe and well-tolerated, and no new safety signals were identified.

The company will explore future development opportunities for aticaprant. Full analyses from the VENTURA development program are underway and will be shared at a future medical meeting.

In January, Neumora Therapeutics, Inc.’s (NASDAQ:NMRA) released data from the Phase 3 KOASTAL-1 Study of navacaprant for major depressive disorder.

The study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) scale.

Navacaprant, like aticaprant, is a kappa opioid receptor antagonist. Johnson & Johnson says it continues to build on its leadership in Neuroscience.

In January, the healthcare giant agreed to acquire Intra-Cellular Therapies Inc. (NASDAQ:ITCI) for $132.00 per share in cash for a total equity value of approximately $14.6 billion.

Johnson & Johnson’s other depression drug Spravato (esketamine), in January, received FDA approval as the only monotherapy for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants.

In 2024, Spravato generated global sales of around $1.01 billion. In May 2024, Johnson & Johnson topline results from Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder with insomnia symptoms.

The study achieved all primary and secondary endpoints, with seltorexant demonstrating both a statistically significant and clinically meaningful improvement in depressive symptoms and improved sleep disturbance outcomes in patients who had a prior inadequate response to SSRI/SNRI antidepressants alone.

Price Action: JNJ stock is down 0.20% at $165.50 during the premarket session at the last check Friday.

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