Alumis announces 28-week data from OLE period of Phase 2 STRIDE trial

Alumis announced 28-week data from the open-label extension 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 Congress held September 25-29 in Amsterdam, Netherlands. ESK-001 is a highly selective allosteric oral tyrosine kinase 2 inhibitor currently being evaluated in the Phase 3 ONWARD clinical program for the treatment of moderate-to-severe plaque psoriasis. The interim 28-week OLE data showed dose-dependent sustained increases in Psoriasis Area and Severity Score endpoint responses observed over time, with the majority of patients achieving PASI 75, the primary endpoint, at the highest dose of 40 mg twice daily. ESK-001 continued to show a favorable safety profile in the OLE. Treatment emergent adverse event frequency and severity were similar across study arms, with the majority being mild-to-moderate and self-limited. In both the Phase 2 STRIDE clinical trial and the ongoing OLE, the most common TEAEs were upper respiratory tract infections, nasopharyngitis, and headaches. Alumis presented three additional abstracts this week at EADV. An oral presentation highlighting biomarker data from the Phase 2 STRIDE clinical trial and an e-poster summarizing exploratory exposure response analyses from ESK-001 clinical trials present evidence indicating the 40 mg twice daily dose, which achieves maximal target inhibition according to blood and skin biopsy biomarkers, leads to the highest response rates. These findings support use of the 40 mg twice daily dose in the ongoing Phase 3 clinical program. Also, an e-poster described data that associated positive efficacy and safety outcomes in the Phase 2 STRIDE clinical trial and OLE with significant improvements in patients reported quality of life and psoriasis-associated pruritus with clear, dose-dependent improvement observed.