JNJ-55308942

iStock, BrasilNut1 Johnson & Johnson is cutting several programs—most of which are in neurology and psychiatry—as the company also pulls back from the infectious diseases market. Johnson & Johnson has discontinued the development of a handful of early- and mid-stage drug candidates, most of which were being advanced for various neurology and psychiatry indications, according to Endpoints News , which first reported the pipeline changes on Tuesday. A pipeline document on J&J’s website indicates that it will no longer continue an Alzheimer’s disease program for seltorexant, a human orexin-2 receptor blocker that was being studied for the treatment of agitation or aggression in patients. J&J had been running a Phase II study of seltorexant in this indication. However, J&J will continue to evaluate seltorexant as a treatment for major depressive disorder with insomnia symptoms. In May 2024, the pharma released Phase III data showing that the drug candidate can elicit statistically significant and clinically meaningful improvements in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale, while also reducing sleep disturbances. J&J is also scrapping the early-stage Parkinson’s disease candidate JNJ-0376. In a business overview presentation released in 2023, the pharma listed the candidate under its precision neurosciences pipeline, touting its “novel mechanisms to modify, treat and/or prevent neurodegenerative disorders.” The pipeline cull also includes JNJ-55308942, a Phase II inhibitor of the P2X7 ion channels, which was being assessed for bipolar depression . J&J’s latest pipeline cuts follow the pharma’s retreat from the infectious diseases space after it announced in July 2023 that it would discontinue seven programs , mostly in hepatitis B. In January 2023, J&J revealed that its HIV vaccine regimen had a disappointing showing in the Phase III Mosaico trial , causing the company to discontinue the study—its second terminated HIV vaccine trial in as many years. In March 2023, J&J dropped out of the respiratory syncytial virus race and terminated the Phase III EVERGREEN trial for its vaccine candidate. At the time, the company said that this decision was driven by a review of the competitive landscape. Earlier this month, J&J discontinued the Phase II field study of its preventive therapy mosnodenvir for dengue. J&J reported its third-quarter 2024 earnings on Tuesday, touting $22.5 billion in sales, representing 5.2% year-over-year growth. Its main growth drivers included the multiple myeloma therapy Darzalex, which brought in $3 billion in sales worldwide, as well as the CAR-T therapy Carvykti and antidepressant nasal spray Spravato, which surged 88% and 55% in Q3, respectively. The company raised its full-year operational sales forecast to $89.4 billion to $89.9 billion, up from its previous estimate of $89.2 billion to $89.6 billion.

The programme changes were reflected in a pipeline list on the company’s website. Image credit: Shutterstock/MichaelVi. 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”. See Also: MHRA puts technology in the spotlight in 2024/25 business plan Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production 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.