A despair drug candidate that’s a key a part of Johnson & Johnson’s neuroscience technique has failed a Part 3 scientific trial, the most recent dose of disappointing information for an rising class of medicines addressing a novel goal hoped to beat limitations of at the moment accessible antidepressants.
J&J is discontinuing the Part 3 check of its drug, aticaprant, in main depressive dysfunction “as a consequence of inadequate efficacy within the goal affected person inhabitants,” the corporate stated after Thursday’s market shut. The pharmaceutical large stated this drug was secure and well-tolerated by sufferers, and no new security indicators have been recognized. No different particulars in regards to the trial outcomes have been disclosed.
The open-label scientific trial’s focused enrollment was 840 adults ages 18 to 74. Individuals obtained aticaprant as soon as day by day as an adjunct to despair medicine they have been already taking. Efficacy objectives for the 54-week examine embrace measuring the proportion 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, opposed results which might be widespread with at the moment accessible despair medicines and lead many sufferers to cease taking them. Aticaprant was hoped to keep away from or not less than scale back these unwanted side effects. Higher efficacy and improved security and tolerability can be key benefits over the present slate of antidepressants. Analysts had projected aticaprant would grow to be a blockbuster product.
J&J stated evaluation of the failed examine is underway and extra particulars will likely be introduced at a future medical assembly. However despite the fact that this Part 3 trial is ending, J&J isn’t giving up on aticaprant. Primarily based on the potential of the drug’s mechanism, the corporate stated it’s going to 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 method 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 day by day capsule didn’t beat a placebo on the primary efficacy aim of a Part 3 scientific trial.
Earlier this week, Neumora stated it’s going to finish the failed Part 3 examine, one in all three late-stage assessments for navacaprant. However the firm additionally stated it’s going to apply learnings from the failed check to the 2 different Part 3 research, which have been paused for now. Adjustments embrace optimizing web site 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 so as to commit its sources to its main depressive dysfunction scientific analysis.
[Paragraph added with analyst comments.] In a be aware despatched to buyers Friday, William Blair analyst Myles Minter acknowledged Neumora’s explanations for the trial failure and the deliberate changes to the 2 different Part 3 assessments. 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 examine’s likelihood of success to five% and likewise downgraded the biotech’s shares.
As for J&J, the corporate’s neuroscience portfolio consists of the blockbuster schizophrenia drug Invega and the nasal spray despair drug Spravato. The pharma large is bringing a despair drug prospect into the fold by way of the $14 billion acquisition of Intra-Mobile Therapies introduced in January. Intra-Mobile’s fundamental asset is Caplyta, which has approvals in schizophrenia and bipolar despair. The drug is at the moment beneath FDA evaluate for main depressive dysfunction, a sign that would make the once-daily capsule a blockbuster vendor. J&J expects to finish the Intra-Mobile acquisition later this 12 months.
Picture: Mario Tama, Getty Photos
