Crohn’s patients see 65% remission in clinical trial

pharmafile | November 18, 2021 | News story | Business Services  

Janssen has announced topline results from the Phase II GALAXI 1 clinical which showed rates of clinical remission previously reported at week 12 increased at week 48, among adults with moderately to severely active Crohn’s disease (CD), when treated with TREMFYA® (guselkumab). Week 48 saw 65% of patients who were receiving TREMFYA achieving clinical remission.

Previously, Janssen announced week 12 interim analyses from the 48-week, double-blind, placebo-controlled, multicenter Phase II dose-ranging GALAXI 1 study. GALAXI 1 evaluated the efficacy and safety of TREMFYA in participants with moderately to severely active CD with inadequate response, or intolerance to, conventional therapies (including corticosteroid and immunosuppressive treatments), and other biologics.

“We look forward to sharing the comprehensive GALAXI 1 48-week results at an upcoming scientific medical meeting while we continue to progress and enroll patients with the pivotal Phase III GALAXI 2 and 3 studies,” shared Jan Wehkamp, MD, Vice President, Gastroenterology Disease Area Leader, Janssen Research and Development, LLC.

Crohn’s disease is an inflammatory bowel disease affecting any segment of the gastrointestinal tract, with symptoms including diarrhoea, stomach aches and cramps, fatigue, weight loss, abdominal distension, fever, and blood in the stool. Bowel obstruction may occur as a complication of chronic inflammation, and those with the disease are at a greater risk of colon cancer and small bowel cancer. The precise causes of CD are still unknown. However, the disease is associated with abnormalities of the immune system potentially triggered by a genetic predisposition, diet, or other environmental factors.

TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the P19 subunit of IL-23, and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases, including moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).

Ana Ovey

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