8-K: Alumis Inc. Announces Positive 52-Week Data from ESK-001 Phase 2 Trial in Psoriasis

Alumis Inc. reports positive 52-week data from the Phase 2 STRIDE clinical trial of ESK-001, demonstrating sustained clinical responses in patients with moderate-to-severe plaque psoriasis.

Summary

• Alumis Inc. announced positive 52-week data from the open-label extension (OLE) of its Phase 2 STRIDE clinical trial evaluating ESK-001 in patients with moderate-to-severe plaque psoriasis.
• The results were presented at the 2025 American Academy of Dermatology Association (AAD) Annual Meeting.
• Patients receiving 40 mg twice daily dosing of ESK-001 achieved long-term sustained or increasing clinical responses through Week 52 compared to Week 12.
• PASI 90 was 61.3% at Week 52 compared to 52.4% at Week 12.
• PASI 100 was 38.8% at Week 52 compared to 26.8% at Week 12.
• sPGA 0 was 38.8% at Week 52 compared to 32.9% at Week 12.
• At Week 52, patients maintained robust clinical improvements in control of itch (NRS4, 81.3%) and quality-of-life (DLQI0/1, 61.3%).
• Treatment with ESK-001 continued to be generally well tolerated at week 52, with safety and tolerability consistent with previously reported data and no new safety findings.
• The Phase 3 ONWARD program is ongoing, with topline data expected in Q1 2026.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results with a favorable safety profile, suggesting a promising outlook for ESK-001. The ongoing Phase 3 program further supports a positive sentiment.

Positives

• ESK-001 showed sustained or increasing clinical responses through 52 weeks.
• PASI 90, PASI 100, and sPGA 0 scores improved from Week 12 to Week 52 with 40 mg BID dosing.
• Patients maintained improvements in itch control and quality of life at Week 52.
• ESK-001 was generally well-tolerated with no new safety findings.
• 80% of PASI-75 responders at Week 12 in the STRIDE trial maintained their PASI-75 response at Week 52.
• 62% of patients showed continued improvement in PASI response at Week 52 compared to Week 12.

Negatives

• Some patients discontinued the study early, which could impact the overall efficacy results.
• 18 patients were non-responders at Week 52, and 11 of those discontinued the study early.

Risks

• The Phase 3 ONWARD program is still ongoing, and the topline data is not expected until Q1 2026.
• The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

The company expects to report topline data from the Phase 3 ONWARD studies in the first quarter of 2026 and is also developing a once-daily modified release oral formulation of ESK-001.

Management Comments

• Dr. Jrn Drappa, Alumis Chief Medical Officer, stated that ESK-001 continues to demonstrate a favorable clinical profile for the potential treatment of moderate-to-severe plaque psoriasis.
• Martin Babler, President and Chief Executive Officer of Alumis, stated that the long-term data further support the highly differentiated profile of ESK-001 and reinforce its potential as a best-in-class TYK2 inhibitor.

Industry Context

This announcement positions Alumis as a potential key player in the oral treatment of moderate-to-severe plaque psoriasis, competing with other companies developing TYK2 inhibitors and other oral therapies for immune-mediated diseases.

Comparison to Industry Standards

• The PASI 90 response rate of 61.3% at Week 52 with ESK-001 40 mg BID is competitive with other oral TYK2 inhibitors in development, such as Deucravacitinib (Sotyktu) from Bristol Myers Squibb, which has shown similar efficacy in clinical trials.
• The safety profile of ESK-001 appears favorable compared to some JAK inhibitors, which have been associated with more significant safety concerns.
• The ongoing Phase 3 ONWARD program will further define ESK-001's position relative to existing and emerging therapies for psoriasis.

Stakeholder Impact

• Positive results could lead to increased shareholder value.
• Successful development of ESK-001 could provide a new treatment option for patients with moderate-to-severe plaque psoriasis.
• Employees may benefit from the company's progress and potential commercial success.

Next Steps

• Continue enrollment in the Phase 3 ONWARD studies.
• Report topline data from the Phase 3 ONWARD program in Q1 2026.
• Continue development of a once-daily modified release oral formulation of ESK-001.

Key Dates