TYK2 inhibitor( Bristol Myers Squibb)

At this year’s American Academy of Dermatology annual meeting, companies like Amgen, Bristol Myers Squibb and Alumis took the stage to report the latest on their dermatology candidates. Here are the highlights: The partners’ anti-OX40 antibody, dubbed rocatinlimab, met the co-primary endpoints of the ROCKET-Ignite trial in moderate to severe atopic dermatitis, according to 24-week data presented Saturday. Just over 40% of patients in the higher dose cohort and around 36% of subjects in the lower dose group achieved a minimum 75% reduction from baseline in their Eczema Area and Severity Index score (EASI-75), with both results proving statistically significant compared with placebo. In the study’s other primary endpoint, around 24% of higher dose patients and 19% of lower dose participants attained a validated Investigator’s Global Assessment (IGA) for atopic dermatitis score of clear or almost clear with a minimum two-point reduction from baseline. Safety wise, pyrexia, chills and headache were the most common side effects. This means there’s still room for Sanofi to differentiate on safety with its OX40-targeting candidate amlitelimab, which seems to be associated with fewer fevers and chills, Jefferies analysts wrote Monday. ROCKET-Ignite is part of Amgen’s broader ROCKET registrational development program, which includes eight trials. Saturday’s results are “optically more compelling” than topline data from the ROCKET-Horizon study and “should help rebuild belief” in the drug class, the Jefferies analysts said. Topline data from the ROCKET-Horizon trial were unveiled in September but at the time, Leerink analysts described them as “underwhelming.” Bristol Myers’ Sotyktu hit the primary endpoint of ACR20 response (which is shorthand for a minimum 20% improvement in disease signs and symptoms) in the Phase 3 POETYK PsA-2 trial, according to late-breaking data presented Saturday. That study enrolled 730 patients with active psoriatic arthritis who had not previously received a biologic disease-modifying antirheumatic drug or had been treated with a TNFα inhibitor. In the primary endpoint, more than half of patients treated with Sotyktu achieved an ACR20 response versus 39% of placebo patients at 16 weeks. The treatment also met key secondary endpoints. Bristol Myers plans to discuss the data with regulatory authorities. Last year, Wall Street projected Sotyktu could reach $1.9 billion in sales in 2030. Johnson & Johnson and Protagonist Therapeutics’ IL-23 receptor blocker, dubbed icotrokinra, could be coming for Sotyktu’s market share, based on data presented Saturday. Icotrokinra met the co-primary endpoints and all key secondary endpoints in the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies, including those measuring its efficacy against Sotyktu. These results were “fully expected based upon historical trial results,” Leerink analysts said in a Sunday note. But taken together with previously announced positive results from the Phase 3 ICONIC-LEAD study, the overall data “underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” Liza O’Dowd, J&J’s head of immunodermatology said in the release. The US drugmaker is now starting the Phase 3 ICONIC-ASCEND trial, which will set icotrokinra head-to-head against its own drug Stelara. The California biotech said its oral TYK2 inhibitor, dubbed ESK-001, showed “sustained or increasing clinical responses” in the open-label extension part of the Phase 2 STRIDE trial in moderate to severe plaque psoriasis. Almost 39% of the patients treated with the 40 mg dose experienced a complete resolution of their lesions at 52 weeks compared with almost 27% at 12 weeks, according to late-breaking data presented Saturday. The trial met its primary endpoint around a year ago. Alumis is already testing ESK-001 in the ongoing Phase 3 ONWARD program, which comprises two parallel studies enrolling 840 patients each. The 40 mg dose is being set against placebo and Amgen’s Otelza. Topline data from the program are expected in the first quarter of 2026. Sotyktu became the first oral TYK2 inhibitor to secure FDA approval for psoriasis back in September 2022. But last week, Leerink analysts said ESK-001 has best-in-class potential thanks to its “superior target inhibition.” The candidate is also being advanced for systemic lupus erythematosus.