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Alumis Inc, 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, announced positive 28 weeks 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 at Amsterdam in Netherlands.
Data presented at EADV of ESK-001, an oral TYK2 inhibitor for the treatment of psoriasis demonstrated significant responses with sustained increases over 28 weeks in phase 2 OLE study.
ESK-001 is a highly selective allosteric oral tyrosine kinase 2 (TYK2) inhibitor currently being evaluated in the phase 3 ONWARD clinical programme 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 programme.”
The phase 3 clinical programme is supported by positive data from the phase 2 STRIDE clinical trial in which 228 patients were randomized to one of five ESK-001 dose cohorts or placebo. The trial met its primary endpoint, the proportion of patients achieving a PASI 75 at week 12 compared to placebo, and key secondary efficacy endpoints at all clinically relevant doses tested. Clear dose-dependent responses were observed with maximal efficacy and TYK2 inhibition achieved at the highest dose of 40 mg twice daily. ESK-001 was found to be generally well tolerated at all dose levels.
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.
28 weeks data shows 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.
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