Bristol Myers Squibb will push its TYK2 inhibitor into phase 3 trials for lupus later this year off the back of positive midstage data as the drug awaits a key FDA decision for psoriasis.
BMS reported Wednesday that the drug, deucravacitinib, hit its primary endpoints in a phase 2 study in systemic lupus erythematosus (SLE). The 3-mg and 6-mg doses of the therapy taken twice daily both achieved SLE Responder Index-4 (SRI(4)—a composite endpoint used in SLE clinical trials to assess disease activity—at Week 32, the big pharma said.
While the 12-mg, once-daily dosing group had numerically higher SRI(4) responses relative to placebo at 32 weeks, the results did not reach statistical significance. BMS told Fierce Biotech that it could not confirm whether it would take all three doses into the upcoming phase 3 trial, as the details are still being ironed out with regulators.
Regardless, a spokesperson for the company said the phase 2 results represent a “step forward” in the development of a potential new therapy to help those living with SLE, for which no new oral drug has entered the market in over 60 years.
Secondary endpoints in the 363-person trial demonstrated clinically meaningful improvements at Week 48, including SRI(4), the Composite Lupus Assessment, Lupus Low Disease Activity State, and a decrease of 50% or more from baseline on the Cutaneous Lupus Erythematosus Disease Area and Severity Index.
Deucravacitinib was well tolerated in the SLE trial, with the safety profile consistent with earlier trials in psoriasis and psoriatic arthritis, the company added.
The welcome findings come after BMS has faced setbacks growing the deucravacitinib program while it awaits an FDA decision on the drug to treat plaque psoriasis, which the spokesperson confirmed to Fierce is still on schedule for Sept. 10.
Deucravacitinib is one of the more advanced selective TYK2 inhibitors in clinical studies across multiple immune-mediated diseases. A previous trial in lupus nephritis had to close due to a lack of enrollment.
The drug is still undergoing trials in Crohn’s disease, ulcerative colitis (UC) and discoid lupus erythematosus, but the spokesperson would not provide more details on timelines. It flopped in a UC trial last year but still believes the drug will win through and make good on the $4 billion peak annual sales projections it's made for the med.
BMS blamed the six-decade wait by lupus patients for a new oral drug on the difficulty in demonstrating the efficacy of potential therapies in clinical trials. This was a result of a number of factors, including underlying disease pathways varying across patient populations, and the fluctuating nature of the condition causing high response rates in placebo cohorts, the spokesperson explained.
There is an urgent need for new SLE treatments as half of patients do not respond adequately to current treatment options, said the spokesperson, who pointed out that BMS began its lupus research almost a decade ago. GSK has marketed its injected lupus drug Benlysta since 2011, but R&D in the space was sparse for years afterward.
Since then, there has been more uptick in trial successes from the likes of Biogen and AstraZeneca over the past few years. In fact, AZ nabbed approval for its lupus med, now known as Saphnelo, last August. The therapy works as a type I interferon receptor antibody and is approved for certain SLE patients.