Bristol Myers Squibb's deucravacitinib flunks midphase IBD trial, raising questions about potential blockbuster

Bristol Myers Squibb’s deucravacitinib has hit its first bump in the road. After blowing Amgen’s Otezla away in psoriasis, deucravacitinib went into a phase 2 readout in ulcerative colitis flying high—only to fail to meet the primary or secondary endpoints. 

The clinical trial randomized 131 patients with moderate to severe ulcerative colitis to receive the oral TYK2 inhibitor deucravacitinib or placebo for 12 weeks. Deucravacitinib failed comprehensively, missing the primary clinical remission endpoint and the secondary efficacy endpoints. The secondary endpoints in the study looked at clinical and endoscopic responses along with histological improvement.

BMS downplayed the setback, reiterating its forecast that deucravacitinib will rack up sales of more than $4 billion in 2029 and pointing to the drug’s raft of opportunities. Deucravacitinib may even bounce back in ulcerative colitis, with a second study of a higher dose yet to deliver data.

Even so, the failure in the first midphase ulcerative colitis study is a setback for a drug candidate that was thrust into the spotlight by BMS’ decision to offload Otezla. As it assessed BMS’ takeover of Celgene, the Federal Trade Commission made the sale of Otezla a condition of the closing of the deal to ensure the Big Pharma remained incentivized to develop its own oral psoriasis prospect, deucravacitinib.

RELATED: BMS' deucravacitinib beats out exiled Otezla, plots 2022 launch

BMS’ faith in deucravacitinib was rewarded with phase 3 wins over Otezla in psoriasis. But any hopes the candidate would enjoy a smooth run to market in other indications have been hit by the failure in ulcerative colitis. The question now is whether the failure is a blip or an omen of more efficacy shortcomings as development expands beyond psoriasis.

Investigators are now enrolling patients with conditions including Crohn’s disease, psoriatic arthritis and lupus in phase 2 and 3 clinical trials. The roster of clinical trials will deliver a series of data drops over the coming years that will define the future of deucravacitinib outside of psoriasis.