Teva Pharmaceuticals and Sanofi’s monoclonal antibody (mAb) has shown durable clinical and endoscopic efficacy in a Phase IIb trial in ulcerative colitis (UC) and Crohn’s disease (CD).
In the RELIEVE UCCD long-term extension (LTE) study (NCT05668013), patients treated with duvakitug, an investigational human mAb targeting anti-TNF-like ligand 1A (TL1A), who had initially responded in the 14-week induction phase, saw maintained benefit over a further 44 weeks.
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In UC, 58% and 47% of patients in the 900mg and 450mg cohorts, respectively, achieved the primary endpoint of clinical remission per the modified Mayo score (mMS).
In CD, 55% and 41% of patients, who received the same high and low dose, achieved the primary endpoint of endoscopic response as defined by the Simple Endoscopic Score for CD (SES-CD).
Both doses of duvakitug were well tolerated, with the most frequently observed adverse events (AEs) being upper respiratory tract infection, nasopharyngitis, CD, and hypertension.
Detailed results from the study will be presented at a forthcoming medical meeting.
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By GlobalDataRELIEVE UCCD LTE was a double-blind, randomised study evaluating the long-term efficacy, safety, and tolerability of duvakitug in UC and CD, the two most common forms of inflammatory bowel disease (IBD). The study enrolled 130 patients who responded to duvakitug in the RELIEVE UCCD induction study.
Dr Eric Hughes, executive vice president of global R&D and chief medical officer at Teva, said: “One of the persistent challenges in treating UC and CD isn’t just achieving an initial response, but sustaining it.”
The drug is already in Phase III trials – the STARSCAPE-1 and 2 trials in CD (NCT07184931 and NCT07184944), and the SUNSCAPE-1 and 2 trials in UC (NCT07184996 and NCT07185009). Sanofi, which ousted its CEO last week, paid Teva $500m for rights to codevelop and co-commercialise the anti-TL1A therapy in 2023.
GlobalData, parent company of Clinical Trials Arena, predicts the UC market across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and Canada) will be valued at $9.6bn in 2031. Meanwhile, the CD market is due to be worth $13.8bn across the 8MM in 2032.
GlobalData says that TL1A is an emerging drug class which has gained real interest, noted by prominent pharma buyouts of biotechs that were developing drugs within the modality.
Merck laid out $10.8bn to purchase Prometheus and its anti-TL1A pipeline therapy, PRA023, now known as tulisokibart, in 2023. The drug is already in Phase III trials in UC and CD, and is also in Phase II trials in systemic sclerosis-associated interstitial lung disease (SSc-ILD), rheumatoid arthritis, ankylosing spondylitis, and hidradenitis suppurativa.
Roche has also shown interest in the modality, having acquired Televant in a $7.1bn deal in 2023, which included the rights to RVT-3101 in the US and in Japan.
