What's Happening?
Alumis, a biotech company based in South San Francisco, is set to file for approval of its oral TYK2 inhibitor, envudeucitinib, as a treatment for psoriasis. This decision follows the successful completion
of two phase 3 trials, ONWARD1 and ONWARD2, which demonstrated significant skin clearance in patients with moderate to severe plaque psoriasis. The trials showed that 65% of patients achieved 90% or better skin clearance, and 40% had a complete response at week 24. Envudeucitinib is positioned to compete with Bristol Myers Squibb's Sotyktu, which has been on the market since 2022. Alumis' shares surged by nearly 82% following the announcement, reflecting investor confidence in the drug's potential.
Why It's Important?
The success of envudeucitinib in clinical trials represents a significant advancement in the treatment of psoriasis, a condition affecting millions. If approved, it could provide a more effective oral treatment option compared to existing therapies like Sotyktu. The drug's promising results could challenge the market dominance of injectable biologics, offering patients a less invasive treatment alternative. This development could also impact Bristol Myers Squibb's market share, as envudeucitinib's efficacy appears to surpass that of Sotyktu. The potential approval of this drug could lead to increased competition in the psoriasis treatment market, driving innovation and potentially lowering costs for patients.
What's Next?
Alumis plans to file for regulatory approval of envudeucitinib later this year. The company is also exploring the drug's potential in treating systemic lupus erythematosus, with phase 2b results expected in the third quarter of 2026. The outcome of these regulatory and clinical developments will be closely watched by industry stakeholders, as they could influence future research directions and investment in similar therapeutic areas.
