A significant proportion of subjects with UC who were treated with the therapy achieved clinical remission in the study. Credit: Wasan Tita/Shutterstock.

Sanofi and Teva Pharmaceuticals have reported that the Phase IIb RELIEVE UCCD study of the human IgG1-λ2 monoclonal antibody targeting TL1A, duvakitug, met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD), which are the most common forms of inflammatory bowel disease (IBD).

The dose-ranging, randomised, placebo-controlled study evaluated the therapy for treating moderate-to-severe IBD.

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It was designed to evaluate the therapy’s safety, pharmacokinetics, tolerability, and efficacy in adults with moderate to severe UC or CD.

A significant proportion of the subjects with UC treated with the therapy achieved clinical remission. In total, 36.2% of the subjects on a low dose and 47.8% on a high dose reached remission at week 14, compared to 20.45% with the placebo.

The placebo-adjusted remission rates were 15.7% for the low dose and 27.4% for the high dose.

Subjects with CD also showed positive outcomes, with 26.1% of subjects on a low dose and 47.8% of subjects on a high dose achieving an endoscopic response at week 14, compared to 13% on the placebo.

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Placebo-adjusted response rates were 13% for the low dose and 34.8% for the high dose. The study’s findings indicate a consistent treatment effect across various subgroups.

Regarding safety, duvakitug was generally well-tolerated among participants with UC and CD, with no safety concerns identified.

The rates of treatment-emergent adverse events were comparable between the antibody and placebo groups in both conditions, with all reported adverse events being less than 5%.

As part of their collaboration, Sanofi and Teva will share the development costs and net profits or losses in major markets equally, with other markets being subject to a royalty arrangement.

Sanofi research and development head and executive vice-president Houman Ashrafian said: “These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease. If the magnitude of effect persists in the Phase III programme, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options.”

Earlier this month, Sanofi reported that its Phase III LUNA 3 trial of rilzabrutinib for the treatment of persistent or chronic immune thrombocytopenia in adults met its primary endpoint.