The Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive data from the Phase II GALAXI 1 trial of Tremfya (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), an inflammatory bowel disease.
A fully human monoclonal antibody developed by Janssen, Tremfya can specifically attach to the p19 subunit of interleukin-23 (IL-23) preventing it from interacting with the IL-23 receptor.
The company noted that IL-23 is a key driver of inflammatory disease pathogenesis.
The double-blind, multicentre, placebo-controlled, dose-ranging trial is analysing the efficacy and safety of Tremfya in CD patients who have had insufficient response or tolerance to standard treatments and/or biologics.
Subjects were randomised into five arms to receive either a 200mg, 600mg or 1,200mg intravenous dose of Tremfya at 0, 4 and 8 weeks, respectively, or ustekinumab or placebo.
The change from baseline in Crohn’s Disease Activity Index (CDAI) scores at week 12 was the primary goal of the trial.
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Clinical response and remission, patient report outcome-2 remission, clinical biomarker response, endoscopic response and safety in subjects receiving Tremfya versus placebo, were the other crucial outcomes assessed at week 12.
The latest findings from the trial showed that the rates of clinical remission reported at week 12 rose at week 48 in the subjects treated with Tremfya.
Furthermore, 65% of subjects in Tremfya arms attained clinical remission at week 48.
During the 48-week treatment duration, all Tremfya treatment arms had similar safety data, which were also in line with the already reported safety profile of the drug.
The Phase III trials of Tremfya underway to treat moderately to severely active CD, as well as moderately to severely active ulcerative colitis, are currently enrolling subjects.
Janssen Research & Development Gastroenterology Disease Area Leader vice-president Jan Wehkamp said: “We look forward to sharing the comprehensive GALAXI 1 48-week results at an upcoming scientific medical meeting while we continue to progress and enrol patients in the pivotal Phase III GALAXI 2 and 3 studies.”
Earlier this month, Janssen reported positive data from the Phase III trial of Tremfya for the treatment of active psoriatic arthritis.