Mosnodenvir

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.

No safety issues identified to date RARITAN, NJ, USA I October 4, 2024 I Johnson & Johnson announced today it is discontinuing the Phase 2 field study (NCT05201794) evaluating the efficacy of investigational antiviral candidate mosnodenvir for the prevention of dengue virus in adults aged 18-65 years. The decision to discontinue this study is part of a strategic reprioritization of the Company’s Communicable Diseases research and development (R&D) portfolio. No safety issues were identified. Efficacy data from the Phase 2 field study will be available once the final data analyses, which are now underway, are complete. Study investigators have been notified of the discontinuation. All participants have completed the study per protocol and will be notified of the results once they are ready. Mosnodenvir (formerly JNJ-1802) was shown to be safe and well tolerated in previous Phase 1 and Phase 2a clinical studies. Results from the Phase 2a human challenge study found that the compound induced antiviral activity against dengue (DENV-3) in humans, compared to placebo. Johnson & Johnson will continue to support the fight against dengue by sharing study results with the medical community in the future. Johnson & Johnson’s Commitment to Communicable Diseases Communicable diseases are some of the world’s most entrenched health challenges, impacting the health and safety of billions of people around the world every year. Our Communicable Diseases program builds on our decades of work addressing tuberculosis, HIV, extraintestinal pathogenic E. coli (ExPEC) and neglected tropical diseases like leprosy to help improve lives and create hope for a healthier, safer world. You can learn more about our efforts to address communicable diseases by visiting the Johnson & Johnson Innovative Medicine website . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . SOURCE: Johnson & Johnson