A despair drug candidate that’s a key a part of Johnson & Johnson’s neuroscience technique has failed a Part 3 scientific trial, the newest dose of disappointing information for an rising class of medicines addressing a novel goal hoped to beat limitations of at the moment obtainable antidepressants.
J&J is discontinuing the Part 3 check of its drug, aticaprant, in main depressive dysfunction “because of inadequate efficacy within the goal affected person inhabitants,” the corporate stated after Thursday’s market shut. The pharmaceutical large stated this drug was protected and well-tolerated by sufferers, and no new security alerts had been recognized. No different particulars in regards to the trial outcomes had been disclosed.
The open-label scientific trial’s focused enrollment was 840 adults ages 18 to 74. Contributors acquired aticaprant as soon as each day as an adjunct to despair medicine they had been already taking. Efficacy objectives for the 54-week research embrace measuring the share of sufferers with suicidal ideas or behaviors in addition to the change in rating over time in line with a scale used to evaluate despair signs.
The trial additionally measured for weight acquire and sexual dysfunction, adversarial results which can be frequent with at the moment obtainable despair drugs and lead many sufferers to cease taking them. Aticaprant was hoped to keep away from or no less than cut back these unintended effects. Higher efficacy and improved security and tolerability could be key benefits over the present slate of antidepressants. Analysts had projected aticaprant would develop into a blockbuster product.
J&J stated evaluation of the failed research is underway and extra particulars shall be introduced at a future medical assembly. However although this Part 3 trial is ending, J&J isn’t giving up on aticaprant. Based mostly on the potential of the drug’s mechanism, the corporate stated it would discover future improvement alternatives in different areas of excessive unmet want.
Aticaprant is a small molecule designed to focus on and block kappa opioid receptors, an strategy supposed to modulate pathways that regulate temper and conduct. It’s the identical goal hit by Neumora Therapeutics’ lead drug candidate, navacaprant. In January, Neumora reported this each day tablet didn’t beat a placebo on the principle efficacy purpose of a Part 3 scientific trial.
Earlier this week, Neumora stated it would finish the failed Part 3 research, one among three late-stage exams for navacaprant. However the firm additionally stated it would apply learnings from the failed check to the 2 different Part 3 research, which have been paused for now. Adjustments embrace optimizing website choice and enhancing medical monitoring to make sure acceptable sufferers are enrolled. Neumora plans to renew the 2 research later this month; preliminary knowledge are anticipated in 2026. Neumora additionally stopped a Part 2 check of navacaprant in bipolar despair with the intention to dedicate its sources to its main depressive dysfunction scientific analysis.
[Paragraph added with analyst comments.] In a be aware despatched to traders Friday, William Blair analyst Myles Minter acknowledged Neumora’s explanations for the trial failure and the deliberate changes to the 2 different Part 3 exams. However he added that the back-to-back Part 3 misses for Neumora and J&J towards the kappa opioid receptor diminishes confidence on this goal as a mechanism for treating main depressive dysfunction. The agency has lowered the Neumora research’s likelihood of success to five% and in addition downgraded the biotech’s shares.
As for J&J, the corporate’s neuroscience portfolio contains the blockbuster schizophrenia drug Invega and the nasal spray despair drug Spravato. The pharma large is bringing a despair drug prospect into the fold through the $14 billion acquisition of Intra-Mobile Therapies introduced in January. Intra-Mobile’s principal asset is Caplyta, which has approvals in schizophrenia and bipolar despair. The drug is at the moment beneath FDA overview for main depressive dysfunction, a sign that would make the once-daily tablet a blockbuster vendor. J&J expects to finish the Intra-Mobile acquisition later this yr.
Picture: Mario Tama, Getty Pictures
