In the plaque psoriasis arena, Sotyktu is facing off against Amgen’s Otezla and is facing the threat of upcoming competition from Alumis’ investigational TYK2 inhibitor.
Bristol Myers Squibb is building up to a label expansion for Sotyktu, with positive late-stage results from the POETYK PsA-2 study pointing to the potential of its TYK2 inhibitor in psoriatic arthritis.
54.2% of patients in the treatment arm saw at least a 20% improvement in signs and symptoms at 16 weeks, versus 39.4% in the placebo arm. The treatment difference was statistically significant, hitting a p-value of 0.0002, according to the pharma’s news release. The data were presented at the annual meeting of the American Academy of Dermatology in Orlando, Florida.
Sotyktu also hit the trial’s key secondary endpoints related to disease activity. Patients treated with the TYK2 blocker experienced greater improvements in clinical signs and symptoms of psoriatic arthritis versus placebo and had better disability and patient-reported outcomes.
Sotyktu was safe and well-tolerated overall, and its adverse event profile in POETYK PsA-2 was similar to what had been established in prior trials.
Edgar Charles, vice president and senior global program lead of Early & Late Development Immunology at BMS, in a statement called these findings “promising,” adding that they point to the “potential of Sotyktu as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis.”
Sotyktu is an orally available blocker of the TYK2 protein, a member of the broader JAK family of proteins that plays a mediator role in various cytokine pathways. The drug was first approved in September 2022 for plaque psoriasis, with the company at the time touting Sotyktu as the first oral innovation in the indication in almost 10 years.
Sotyktu has a cleaner safety profile than other JAK inhibitors. At the time of its approval, Jonathan Sadeh, senior vice president of Immunology and Fibrosis Development at BMS, told BioSpace that Sotyktu’s adverse event profile “is very different from the current oral standard of care and from the class of JAK inhibitors.”
“In our trials, we didn’t see the same side effects of anemia, neutropenia, lymphopenia, liver dysfunction or lipid dysfunction, that are typically associated with that class,” he added.
But Sotyktu is playing in a crowded space, and even with this safety edge, BMS’ drug still faces stiff competition and looming challengers. In August 2023, for instance, almost a year after Sotyktu’s approval, a report from Spherix Global Insights found that Amgen’s oral drug Otezla—which incidentally Amgen acquired from BMS subsidiary Celgene—“has been successful at protecting its corner of the market, without losing any material share” to Sotkytu.
Meanwhile, San Francisco biotech Alumis in June 2024 went public to help bankroll the late-stage development of its lead TYK2 inhibitor ESK-001, positioning it as a rival to Sotyktu.
Recently, Alumis signed a merger agreement with fellow immune player Acelyrin to combine their resources and expertise. The combined entity will continue developing ESK-001, targeting moderate-to-severe plaque psoriasis and systemic lupus erythematosus.
