Alumis reported long-term clinical data showing that more than half of patients treated continuously with envudeucitinib achieved complete skin clearance after up to 48 weeks, strengthening the company’s plans to seek U.S. approval for the oral psoriasis treatment.
Topline results from the ONWARD3 long-term extension study showed that 54% of patients achieved PASI 100, a measure representing complete skin clearance.
Another 75% achieved PASI 90, representing at least a 90% improvement in psoriasis severity. The analysis included 773 patients who received continuous envudeucitinib treatment for up to 48 weeks.
Alumis said envudeucitinib remained well tolerated and maintained a safety profile consistent with its ONWARD1 and ONWARD2 studies.
The company characterized the 54% PASI 100 result as the highest reported complete-clearance response rate among oral therapies for moderate-to-severe plaque psoriasis.
Alumis remains on track to submit a New Drug Application to the FDA for envudeucitinib in moderate-to-severe plaque psoriasis during the fourth quarter of 2026.
The company is also evaluating the TYK2 inhibitor beyond psoriasis. Potentially pivotal Phase 2b LUMUS topline results in systemic lupus erythematosus are expected in the third quarter of 2026.
Depending on those results and capital-allocation considerations, Alumis plans to prioritize Sjögren’s disease and cutaneous lupus erythematosus as additional indications for envudeucitinib.
Alumis is separately advancing A-005, a CNS-penetrant TYK2 inhibitor, with plans to begin a Phase 2 biomarker trial in patients with Parkinson’s disease during the first half of 2027.
The expanding development strategy reflects Alumis’s effort to build what management describes as a broader TYK2 franchise rather than relying on a single psoriasis indication.
KEY QUOTES:
“The ONWARD3 long-term data delivered the highest reported PASI 100 response rate among oral therapies, positioning envudeucitinib to set a new standard in PsO.”
Martin Babler, President and Chief Executive Officer of Alumis
