Janssen has released new safety and efficacy data from a Phase III trial investigating Tremyfa (guselkumab) in adults with moderately to severely active ulcerative colitis (UC).
Tremyfa is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to the human interleukin (IL)-23 receptor.
The newly released data showed that Tremyfa demonstrated statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures. A significantly greater proportion of patients treated with the drug achieved clinical remission at week 12 compared to the placebo cohort.
In the fourth week of treatment, 22.6% of treated patients achieved symptomatic remission compared to 12.9% of the subjects in the placebo group. At the end of the treatment, a greater proportion of the treatment cohort achieved clinical response, endoscopic improvement, histo-endoscopic mucosal improvement, and endoscopic normalisation.
Tremyfa’s safety profile was consistent with the known profile in already approved indications. Frequencies of treatment emergent adverse events (AEs) were generally comparable to placebo, with numerically fewer serious AEs and AEs leading to discontinuation of treatment.
The Phase III Induction study (NCT04033445) outcomes were analysed from 701 patients with UC who had an inadequate response or intolerance to conventional and/or advanced therapies. Subjects were randomised at 3:2 ratio who received an intravenous (IV) 200mg dose of Tremyfa or placebo.
While Tremyfa was marketed as a subcutaneous (SC) injection as a treatment for plaque psoriasis and psoriatic arthritis in 2017, it is not approved for the treatment of adults with UC in the US.
Further research on Tremyfa
Janssen is also conducting a Phase III trial investigating Tremyfa as a SC induction in patients with moderately to severely active UC (NCT05528510). The primary endpoint of the trial is measuring the clinical remission at week 12.
Additionally, Tremyfa is currently being studied in two Phase III trials in patients with moderately to severely active Crohn’s disease (CD). The subcutaneous therapy trial (NCT05197049) is measuring clinical remission and endoscopic response at week 12 as the primary endpoint.
The other Phase III trial (NCT03466411) is investigating the combination of IV and SC administrations compared to Janssen’s Stelara (ustekinumab). The primary endpoint is measuring clinical response at week 12, clinical remission and endoscopic response at week 48 based on Crohn’s Disease Activity Index (CDAI) score.
UC and CD are both under the umbrella term of inflammatory bowel disease (IBD) that causes chronic inflammation of the gastrointestinal tract. The estimated prevalence of IBD was 321.2 per 100,000 population in 2021. The prevalence rate has increased by 46% compared to 2006. While the incidences are increasing, IBD trials are faced with decreased enrolment rates. In February, Clinical Trials Arena explored the challenges of declining enrolment and ways to improve the participant experience.