Sanofi and Teva Pharmaceuticals’ inflammatory bowel disease (IBD) drug has shown benefit in patients with both ulcerative colitis (UC) and Crohn’s disease.
The companies have debuted new data from a mid-stage study, which has highlighted the role of their co-developed investigational drug, duvakitug, in the Phase IIb RELIEVE UCCD trial (NCT05668013).
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In the study, Teva randomised 247 patients with moderate-to-severe active UC or Crohn’s disease to receive either 450mg or 900mg of duvakitug once every four weeks.
During the study, 58% of UC patients treated with 900mg of duvakitug experienced clinical remission as per the modified Mayo Score at the end of the week 44 maintenance phase – meaning active symptoms of the disease such as rectal bleeding, pain and increased trips to the toilet had stopped. Meanwhile, 87% of patients given the same regimen had experienced a clinical response from baseline.
On top of the positive outcomes in UC, duvakitug prompted endoscopic improvements in 58% of the patients in the high dose arm at week 44, meaning disease activity either ceased or continued at a mild rate following treatment.
Patients with UC were not the only ones to accrue benefit from duvakitug, with patients in the Crohn’s portion of the study also experiencing notable treatment benefits from the drug, with the clinical response and remission rates in the 900mg cohort sitting at 87% and 84%, respectively.
Similarly to UC, duvakitug triggered high rates of endoscopic responses in patients with Crohn’s at week 44, meaning they had experienced a reduction of at least 50% in visible disease severity – as measured by factors like how narrow the colon was, as well as the presence and severity of mucosal ulcers compared with baseline following treatment.
Patients generally tolerated Sanofi and Teva’s anti-TL1A therapy well in the maintenance period, with researchers observing no new safety signals linked to the drug’s long-term use. Discontinuation rates linked to adverse events (AEs) ranged between 2% and 4% for patients with UC, while standing at 6% in the Crohn’s population.
These results will be welcome news for Sanofi and Teva, which are currently conducting late-stage studies on duvakitug in the same indications. Sanofi originally secured the rights to co-develop and commercialise the therapy in 2023 through a $500m deal.
In a recent research note, Leerink analysts touted the future potential of duvakitug and the wider anti-TL1A class in UC and Crohn’s, noting that they were “optimistic” about the mechanism of action (MOA), as well as its uptake in these conditions – provided it secures approval.
“TL1A makes mechanistic sense to us to reduce inflammation and potentially reverse fibrosis if preclinical effects are replicated in humans,” the analysts commented, adding that duvakitug in particular could hold potential due to its high potency and lower levels of anti-drug antibodies and DcR3-sparing selectivity, which could offer it differential value against other drugs being developed in this class.
In recent years, the anti-TL1A mechanism has been attracting hefty sums of cash from big pharma, with MSD outlaying $10.8bn to acquire Prometheus Therapeutics and its anti-TL1A candidate, tulisokibart, in 2023. Since then, the drug has gone on to score a Phase III win in UC.
Meanwhile, Swiss pharma giant Roche also entered the anti-TL1A race through its $7.1bn deal with Roivant Therapeutics centred around its asset, afimkibart. The drug is currently in Phase III for both Crohn’s and UC.
