Bristol Myers Squibb’s deucravacitinib, seeking to become the first TYK2 drug approved, flopped a key phase II test in ulcerative colitis, which failed to stimulate clinical remission at three months and lacked key secondary endpoints during an interim registration, the drug giant admitted on Thursday.
Details were slim in a press release, but Bristol Myers noted that he still plans to pursue deucravacitinib in ulcerative colitis – another Phase II trial is currently underway – along with a host of other indications for what he still sees as a $ 4 billion a-year peak in sales by the end of the decade.
“Although we did not obtain a proof of concept in this study, we are committed to advancing our clinical program of deucravacitinib in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. CMO Samit Hirawat said in a short statement.
Bristol Myers expects full data to be released at a later date.
While the drug giant played down the results, a failed test here could cast doubt not only on the drug Bristol Myers envisioned as a next-generation follow-up to Otezla – the $ 13.4 billion in lost money. acquisition of Celgene – but the TYK2 pathway as a whole, which seeks to bypass JAK inhibition completely and avoid the severe side effects associated with these drugs.
Bristol Myers already has phase III winning data for deucravacitinib in hand in head-to-head psoriasis confrontations against Otezla detailed in April, which are expected to form the basis of a first filing in the coming months.
In these studies, deucravacitinib significantly reduced disease activity in patients with psoriasis and stimulated clearer skin at four months than patients receiving Otezla or placebo. In terms of PASI 75, a measure of disease severity, 58.7% and 53.6% of patients on deucravacitinib achieved a PASI 75 response, respectively, in the POETYK-PSO-1 and POETYK-PSO- studies. 2. Meanwhile, only 12.7% and 9.4% of patients on placebo and 35.1% and 40.2% of patients on Otezla achieved the same result. Bristol Myers called these results significant without revealing the p-values ââat the time.
Bristol Myers touted deucravacitinib as one of four successful programs underway with the potential to earn over $ 4 billion per year. The other three were mavacamten, acquired during the MyoKardia takeover, as well as the anemia drug Reblozyl and the company’s cancer cell therapy franchise, which has so far obtained two approvals with Abecma and Breyanzi.