Core Viewpoint - Alumis announced positive top-line results for its next-generation oral TYK2 inhibitor, Envudeucitinib (ESK-001), in two pivotal Phase III clinical trials for moderate to severe plaque psoriasis, indicating best-in-class potential with high statistical significance across all primary and secondary endpoints [1][6]. Clinical Efficacy - At week 16, approximately 74% of patients achieved PASI 75 and sPGA 0/1, significantly outperforming the placebo group (p < 0.0001) [5]. - By week 24, around 65% of patients reached PASI 90, with over 40% achieving PASI 100, indicating complete skin clearance [5]. - Envudeucitinib demonstrated superior efficacy compared to the widely used oral drug Apremilast at all PASI endpoints by week 24 [5]. Rapid Onset and Safety - The drug exhibited rapid onset of action, with significant separation from the placebo group observed at week 4 for PASI 90 [6]. - Envudeucitinib showed good tolerability, with most treatment-emergent adverse events being mild to moderate, including headache, nasopharyngitis, upper respiratory infections, and acne, with no new major safety signals identified [6]. Transformative Impact on Treatment Landscape - The results are expected to transform the treatment landscape for psoriasis, providing a high-efficacy oral option that rivals biologics while maintaining safety [7]. - The CEO of Alumis expressed confidence in the drug's differentiated clinical profile, highlighting its potential as a "pipeline-in-a-pill" for other diseases, including systemic lupus erythematosus [7]. - The company plans to present more results from the ONWARD1 and ONWARD2 trials at an upcoming medical conference and intends to submit a new drug application to the FDA in the second half of the year [7].
股价暴涨95.31%!优于安进,Alumis治疗斑块型银屑TYK2抑制剂三期获成功!
美股IPO·2026-01-06 23:16