Late-Breaking Data at EADV of ESK-001, an Oral TYK2 Inhibitor for the Treatment of Psoriasis, Demonstrate Significant Responses with Sustained Increases Over 28 Weeks in Phase 2 OLE Study

• 28-week data show ESK-001 was generally well tolerated and most patients treated with the top dose of 40 mg twice daily achieved PASI 75
• Three additional data presentations further support ESK-001’s potential to offer a highly differentiated and best-in-class treatment profile for people with moderate-to-severe plaque psoriasis
• Full 52-week Phase 2 OLE dataset expected 1H 2025; Phase 3 clinical program ongoing

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Sept. 27, 2024 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a clinical stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today announced positive 28-week data from the open-label extension (OLE) period of its Phase 2 STRIDE clinical trial of ESK-001. These data were presented during a late-breaking oral session at the 2024 European Academy of Dermatology & Venereology (EADV) Congress held September 25-29 in Amsterdam, Netherlands. ESK-001 is a highly selective allosteric oral tyrosine kinase 2 (TYK2) inhibitor currently being evaluated in the Phase 3 ONWARD clinical program for the treatment of moderate-to-severe plaque psoriasis.

“The OLE results continue to show that ESK-001 has the potential to safely and effectively inhibit the TYK2 target at the 40 mg twice daily dose and deliver lasting benefits that improve over time with continued treatment,” said Dr. Jörn Drappa, Alumis’ Chief Medical Officer. “These data reinforce our confidence in ESK-001’s potential as a best-in-class oral treatment for moderate-to-severe plaque psoriasis. We look forward to reporting the full 52-week OLE data in the first half of 2025 and continuing to advance ESK-001 in the Phase 3 ONWARD clinical program.”

The interim 28-week OLE data (as of March 1, 2024) showed dose-dependent sustained increases in Psoriasis Area and Severity Score (PASI) endpoint responses observed over time, with the majority of patients (93% as observed (AO, n=71), 82.7% using modified non-responder imputation (mNRI, n=81)) achieving PASI 75, the primary endpoint, at the highest dose of 40 mg twice daily.

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