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Johnson & Johnson (NYSE:JNJ) today announced new 96-week data from the long-term extensions (LTE) of the Phase 3 GRAVITI, GALAXI 2 and GALAXI 3 studies, which show the durability of TREMFYA® (guselkumab) in adults with moderately to severely active Crohn's disease (CD) at two years.1 These findings are among 23 Johnson & Johnson abstracts being presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG).
TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies. 2 3 4 5 6
At Week 96, patients treated with TREMFYA® 400 mg subcutaneous (SC) induction (GRAVITI) or 200 mg intravenous (IV) induction (GALAXI) followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) show high rates of long-term clinical remission, endoscopic response, endoscopic remission, and deep remission.
| At Week 96 (as observed)*: | TREMFYA® 100 mg q8w | TREMFYA® 200 mg q4w |
Clinical remissiona GRAVITI GALAXI 2, 3 (pooled) | 92.0% 86.7% | 93.4% 87.1% |
Endoscopic responseb GRAVITI GALAXI 2, 3 (pooled) | 65.0% 73.6% | 65.1% 70.7% |
Endoscopic remissionc GRAVITI GALAXI 2, 3 (pooled) | 41.5% 56.3% | 46.0% 56.6% |
Deep remissiond GRAVITI GALAXI 2, 3 (pooled) | 38.7% 51.2% | 44.1% 49.0% |
*The as observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 96; participants who had a dose adjustment (GALAXI only) were not included at Week 96.
Safety data through 96 weeks in the LTE periods of the GALAXI and GRAVITI studies were consistent with the well-established safety profile of TREMFYA®.
"Crohn's disease is a chronic condition that can greatly impact a patient's quality of life," said David Rubin, MD, Director of the Inflammatory Bowel Disease Center at the University of Chicago.e "These results show that guselkumab can provide endoscopic remission through either SC or IV induction, allowing people with moderate to severely active Crohn's disease to manage their condition with greater independence and confidence."
The GRAVITI study evaluated TREMFYA® SC induction and maintenance therapy versus placebo.7 The GALAXI 2 and 3 studies evaluated TREMFYA® IV induction and SC maintenance therapy versus placebo and STELARA® (ustekinumab).8 Previously presented pooled data from the GALAXI clinical program showed TREMFYA® was superior to STELARA® for all endoscopic endpoints at Week 48, the only IL-23 inhibitor to achieve this in a double-blinded registrational program.9
"As the only IL-23 inhibitor approved for both subcutaneous SC and IV induction in Crohn's disease and now also in ulcerative colitis, TREMFYA provides patients and their providers with meaningful choices in how they begin treatment with proven long-term benefits," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "These results underscore our legacy of delivering innovations that address the diverse needs of people living with IBD, while continuing to provide treatment options that deliver deep and sustained remission over time."
TREMFYA® has received U.S. Food and Drug Administration (FDA) approval for both SC and IV induction options for the treatment of adults with moderately to severe active Crohn's disease and for the treatment of adults with moderately to severely active ulcerative colitis.
Posted In: JNJ
