Sanofi and Teva Pharmaceuticals have reported new outcomes from the randomised Phase IIb RELIEVE UCCD trial of human immunoglobulin G 1(IgG1)-λ2 monoclonal antibody, duvakitug, in treating moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD).

The double-blinded, 14-week, dose-ranging study was designed to assess the safety, pharmacokinetics, tolerability and efficacy of the antibody in the adult population with this condition.

It demonstrated that subjects receiving the therapy showed significantly higher rates of clinical remission, the primary endpoint, at week 14 than those on a placebo in the UC cohort.

Specifically, 36% of subjects on a 450mg dose and 48% on a 900mg dose achieved the primary endpoint versus 20% for the placebo group.

In the advanced therapy (AT)-experienced subgroup, 29% on the 450mg dose and 36% on the 900mg dose reached clinical remission. In the AT-naïve subgroup, the remission rates were 39% for the 450mg dose and 53% for the 900mg dose.

Additional endpoints showed outcomes with endoscopic remission rates of 17% for the 450mg dose and 26% for the 900mg dose, against 9% for placebo.

Clinical response rates were also observed to be higher among duvakitug-treated subjects than those on placebo.

The safety data from the study indicated that the therapy was generally “well tolerated” in cohorts of UC and CD, with no new safety signals identified.

Sanofi and Teva are partnering on the joint development and commercialisation of the latter’s duvakitug for UC and CD treatment, with both companies sharing development expenses and profits in major markets.

Sanofi will spearhead the Phase III clinical development while Teva and Sanofi will lead commercialisation efforts in different regions.

Last month, Sanofi reported outcomes from its Phase III IRAKLIA trial of Sarclisa (isatuximab) as a potential treatment for multiple myeloma.