J&J Discontinues Seltorexant Trial in Alzheimer's, Citing Portfolio Prioritization
核心洞察
Johnson & Johnson has discontinued its Phase II clinical trial of seltorexant for Alzheimer's disease due to portfolio prioritization.
Seltorexant, a human orexin-2 receptor selective agonist, showed promise in Phase III trials for major depressive disorder with insomnia.
J&J also halted development of JNJ-0376 for Parkinson's and JNJ-55308942 for bipolar disorder (搜索), alongside an early-stage psoriasis (搜索) candidate.
Johnson & Johnson (J&J) has ceased several clinical programs, including a Phase II study of seltorexant in patients with probable Alzheimer’s disease (搜索) (AD). The decision, part of a broader pipeline prioritization, impacts multiple neuroscience assets.
The company communicated the changes via an updated pipeline list on its website, initially reported by Endpoints News. A J&J spokesperson stated, "We regularly prioritize programs in our portfolio to ensure sustainable delivery of transformative medicines to patients with unmet needs."
Seltorexant's Shift in Focus
Seltorexant, a human orexin-2 receptor selective agonist, had previously demonstrated positive results in a Phase III trial as an adjunctive treatment for major depressive disorder (MDD) with insomnia symptoms. The Phase II study (NCT05307692) in Alzheimer’s patients, involving 70 participants with agitation/aggression, had its status changed to “completed” in March.
Despite earlier forecasts suggesting potential peak sales between $1 billion and $5 billion, primarily driven by its application in depression, the discontinuation of the Alzheimer's trial casts doubt on these projections. GlobalData’s Pharma Intelligence Centre forecasts seltorexant sales of $610 million by 2030.
Other Pipeline Adjustments
In addition to seltorexant, J&J has also discontinued the Phase I Parkinson’s (搜索) treatment JNJ-0376 and the Phase II P2X7 antagonist JNJ-55308942, which was being studied in patients with bipolar disorder (搜索) experiencing a major depressive episode. An early-stage psoriasis (搜索) candidate, JNJ-1459, has also been dropped.
Earlier in the year, J&J halted trials for the epilepsy (搜索) drug ADX71149, developed in partnership with Addex Therapeutics, following a Phase II failure.
Financial Performance
The pipeline adjustments coincide with J&J's strong Q3 2024 financial results. Sales of oncology drugs increased by nearly 19%, with multiple myeloma (搜索) treatment Darzalex (daratumumab and hyaluronidase-fihj) contributing significantly. The immunotherapy drug generated over $3 billion, contributing to a 5.2% year-over-year growth for the company.