Johnson & Johnson’s experimental therapy for inflammatory bowel disease (IBD), JNJ-4804, failed to demonstrate a statistically meaningful improvement in patients during Phase 2b clinical trials. However, the company has announced plans to advance the drug into late-stage testing, targeting a specific subgroup of IBD patients.
On Tuesday, trial investigators presented the results of the DUET study, which evaluated the efficacy of combining Tremfya and Simponi to prevent the immune system from attacking healthy tissues in the digestive tract. The study followed a 2022 clinical trial that showed significant benefits, nearly doubling disease remission rates and inspiring other companies to explore combination therapies for IBD.
Johnson & Johnson tested JNJ-4804 in two Phase 2b trials, covering both major forms of IBD: ulcerative colitis and Crohn’s disease. While the combination therapy outperformed the individual drugs in both trials, it did not meet the primary endpoint of achieving clinical remission.
Related articles
U.S. Pressures Germany to Increase Payments for Prescription Drugs Amid Trade Tensions
WASHINGTON — Over a recent breakfast, U.S. officials had a message for the German ambassador: pay more for pharmaceuticals. The meeting, between U.S....
Dr. Makary's Exit and the Future of Cassidy's Senate Seat: Key Health Policy Shifts
This week’s episode of “The Readout LOUD” is all about health politics. We bring on FDA reporter Lizzy Lawrence to discuss Makary’s departure — why he...
BeOne Secures FDA Approval for Novel Lymphoma Cell Therapy, Advancing Autoimmune Treatment Pipeline
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Biotech’s cell therapy boo...
Biogen’s Tau-Targeting Alzheimer’s Drug Shows Promise in Phase 2 Trial; Takeda to Cut 4,500 Jobs by 2026
Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue ski...
Biogen’s Tau-Targeting Alzheimer’s Drug Shows Promise in Mid-Stage Trial
Biogen reported mixed results Thursday from a mid-stage clinical trial investigating a treatment for Alzheimer’s disease that targets the protein tau...
CREATE Medicines Secures $122M to Advance CAR-T Therapies for Solid Tumors and Autoimmune Diseases
CREATE Medicines has a new name, an expanded pipeline, and now fresh funding to propel the company’s first CAR-T candidates through human trials. Up u...
Regenxbio’s Duchenne Gene Therapy Shows Success in Trial, FDA Submission Next
Regenxbio said Thursday that its experimental gene therapy for Duchenne muscular dystrophy produced sufficiently high levels of a miniaturized muscle...
Kyle Diamantas Named Acting FDA Commissioner Amid Biotech Sector Optimism
This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their...