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Envudeucitinib is a next-generation, highly selective, oral allosteric inhibitor of tyrosine kinase 2 (TYK2) precision‑engineered for maximal 24‑hour TYK2 inhibition to correct immune dysregulation across a range of diseases driven by proinflammatory mediators, including IL-23, IL-17.
Source: alumis.com
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Envudeucitinib demonstrated robust skin clearance, achieving high thresholds of clinical response at Week 16 that continued to deepen through Week 24 in both trials. Psoriasis Area and Severity Index (PASI) 90 responses, which emerged as early as Week 4, were achieved by 59.9% and 53.1% of envudeucitinib patients at Week 16 (and by 4.8% and 4.3% of placebo patients), increasing to 68.0% and 62.1% at Week 24. PASI 100 responses followed a similar trajectory, with 29.4% and 27.7% of envudeucitinib patients achieving complete skin clearance at Week 16 (as compared to 0.9% and 0.9% of placebo patients), rising to 41.0% and 39.5% at Week 24.
Envudeucitinib also demonstrated improvements in scalp psoriasis, a high-impact, difficult-to-treat area marked by profound effects on quality of life. At Week 24, approximately three out of four envudeucitinib patients1 achieved clear or almost clear scalp psoriasis, measured by the Scalp Specific Physician’s Global Assessment (ss‑PGA 0/1), with over 30% responding as early as Week 4.
Broad and meaningful clinical benefits emerged early. Notably, quality-of-life and itch improvements appeared before PASI 90 skin clearance responses and continued to deepen through Week 24 across both trials.
- By Week 12, approximately 50% of envudeucitinib patients2 achieved Dermatology Life Quality Index (DLQI) 0/1, demonstrating minimal to no impact of disease on quality of life.
- By Week 16, envudeucitinib patients achieved an average improvement of more than 4 points from baseline on the 0–10 Worst Pruritus Numeric Rating Scale (NRS), with clinically meaningful itch relief as early as Week 2—one of the most burdensome symptoms of psoriasis.
“What stands out with envudeucitinib in these trials is how quickly patients begin to feel relief from symptoms, and how deeply those improvements continue to build,” said leading dermatologist and psoriasis expert Dr. Andrew Blauvelt. “For people living with the daily burden of plaque psoriasis, this degree of skin clearance and symptom improvement from an oral investigational drug is impressive, especially when high‑impact sites are involved.”
Treatment with envudeucitinib was generally well tolerated through Week 24 in both trials, with a safety profile consistent with the Phase 2 program, including its long-term extension study. No clinically significant laboratory abnormalities or cases of tuberculosis reactivation were observed. Treatment-emergent adverse events were mostly mild, transient, self-limited, or responding to standard therapy, with the most common being headache, nasopharyngitis, upper respiratory tract infection, and acne. No new safety signals were observed.
“Envudeucitinib delivered the level of skin clearance, symptom relief, and safety in Phase 3 that the TYK2 mechanism has long promised but that has not been fully realized—until now—with sustained, maximal 24-hour inhibition of the IL-23 / IL-17 pathways,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. “The depth of clinical response, together with the favorable safety profile observed, underscores a differentiated clinical profile among marketed and investigational oral options and supports envudeucitinib’s potential to play a leading role in the treatment of patients with moderate‑to‑severe plaque psoriasis.”
Alumis is continuing to evaluate the long-term efficacy and safety of envudeucitinib in the ONWARD3 long-term extension trial and plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of this year.
Source: alumis.com