J&J trims neuroscience pipeline – seltorexant in Alzheimer’s disease dropped 

J&J has cut two Phase II programmes and one Phase I asset in its neuroscience portfolio.

Robert Barrie October 16 2024

Johnson and Johnson (J&J) has cleaved several clinical programmes, including a Phase II study evaluating seltorexant in patients with probable Alzheimer's disease.

Trials have been cut across the company’s portfolio, with its neuroscience pipeline the most affected, losing two Phase II programmes and a Phase I candidate. J&J has not released any information on its asset prioritisation, with the changes reflected in a pipeline list on the company’s website, as first reported by Endpoints News.

"We regularly prioritise programs in our portfolio to ensure sustainable delivery of transformative medicines to patients with unmet needs," a J&J spokesperson told Pharmaceutical Technology.

Seltorexant is one of J&J’s most promising neuroscience candidates. The human orexin-2 receptor selective agonist produced positive results in a Phase III trial earlier this year as an adjuvant treatment to antidepressants in 588 patients with major depressive disorder (MDD) with insomnia symptoms.

The company had been evaluating seltorexant in a Phase II study (NCT05307692) in 70 patients with probable Alzheimer's Disease (AD) and clinically significant agitation/aggression. The randomised, placebo-controlled, double-blind study’s status on ClinicalTrials.gov had changed in March this year from “recruiting” to “completed”.

The Phase II cut in Alzheimer’s puts a question mark against the lofty heights J&J had envisaged for seltorexant. Less than a year ago, the company said the drug could reach blockbuster status, forecasting peak sales between $1bn and $5bn. The projections were, however, driven by the drug’s potential approval in depression, rather than Alzheimer’s disease. GlobalData’s Pharma Intelligence Centre currently forecasts seltorexant sales of $610m by 2030.

GlobalData is the parent company of Pharmaceutical Technology.

Also on the chopping board in J&J’s neuroscience section is the Phase I Parkinson’s treatment JNJ-0376 and Phase II P2X7 antagonist JNJ-55308942. J&J had shared very little about JNJ-0376 – one of its few mentions coming in a 2023 presentation under early-stage neuroscience pipeline targets with “novel mechanisms” to treat neurodegenerative disorders.

JNJ-55308942, meanwhile, was being studied in patients with bipolar disorder in a major depressive episode. The randomised Phase II study (NCT05328297) enrolled 116 patients and was marked as “completed” in July this year. Outside of neuroscience-related assets, J&J has also tossed its early-stage psoriasis candidate, JNJ-1459.

Earlier this year, the company halted trials of the epilepsy drug ADX71149 being developed in partnership with Addex Therapeutics following a Phase II failure.

The pipeline trim comes at the same time J&J reported strong Q3 financial results for 2024. Sales of the company’s oncology drugs jumped nearly 19%, with multiple myeloma treatment Darzalex (daratumumab and hyaluronidase-fihj) doing much of the heavy lifting. The immunotherapy drug brought in more than $3bn, helping the big pharma turn a 5.2% year-over-year growth.

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