Teva Pharmaceuticals and Sanofi have presented new, positive results from the RELIEVE UCCD Phase 2b study of Duvakitug (TEV’574/SAR447189).
Duvakitug, a monoclonal antibody targeting TL1A, aims to treat moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD), two common forms of inflammatory bowel disease (IBD).
In the UC cohort of the RELIEVE UCCD study, 36% of patients treated with Duvakitug at 450 mg and 48% at 900 mg achieved clinical remission at week 14, compared to 20% in the placebo group. The placebo-adjusted rates were 16% (450 mg) and 27% (900 mg).
Higher remission rates were seen in both advanced-therapy (AT)-experienced and AT-naïve subgroups of patients.
The investigational drug also showed positive results when additional endpoints were evaluated, including clinical response, endoscopic improvement (Modified Endoscopic Score), and histological-endoscopic mucosal improvement (HEMI).
In the CD cohort of the RELIEVE UCCD study, 26% of patients treated with Duvakitug at 450 mg and 48% at 900 mg achieved an endoscopic response at week 14, compared to 13% in the placebo group.
The placebo-adjusted rates were 13% (450 mg) and 35% (900 mg).
Higher response rates were observed in both advanced-therapy-experienced and naïve subgroups.
Duvakitug was generally well tolerated in both UC and CD cohorts, with no new emergent safety signals.
RELIEVE UCCD study lead investigator Vipul Jairath said: “Every day, I see patients with Crohn’s disease who continue to suffer from the often-severe symptoms of the disease despite available treatments.
“The endoscopic response rates seen in this study support the potential of duvakitug as an effective new option for these who are in desperate need of relief.”
Teva and Sanofi are collaborating to co-develop and co-commercialise the drug candidate for UC and CD. The French pharmaceutical company licensed the asset from Teva in a deal valued at approximately $1.5bn in October 2023.
Both companies will equally share global development costs and profit-sharing in major markets, with royalty-based agreements in other regions.
The findings from the RELIEVE UCCD study will form the basis for a Phase 3 clinical programme, expected to begin in the second half of 2025.
In a separate development, Teva and Alvotech have announced the availability of Selarsdi (ustekinumab-aekn) injection in the US.
Selarsdi, a biosimilar to Stelara, is approved for treating psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, paediatric plaque psoriasis, and paediatric psoriatic arthritis.
This marks the second biosimilar launched through their partnership in the US.
