Alumis (ALMS) Study Result summary

Study Design and Patient Population

• ONWARD phase III program was a global, randomized, double-blind, placebo- and active-comparator-controlled study enrolling over 1,700 adults with moderate to severe plaque psoriasis at more than 270 sites across the US, Europe, and Asia in 10 months.

• Patients were randomized to envudeucitinib, placebo, or apremilast for 24 weeks, with placebo patients switching to active treatment at week 16 and a long-term extension available.

• Key inclusion criteria: age ≥18, plaque psoriasis for ≥6 months, PASI ≥12, sPGA ≥3, and ≥10% BSA involvement at baseline.

• About 25% had prior biologic treatment, 75% had moderate and 25% severe disease, mean PASI ~20, and average disease duration of 19 years.

Efficacy and Safety Results

• Both ONWARD1 and ONWARD2 phase III trials met all primary and secondary endpoints with high statistical significance, showing superior skin clearance versus placebo and apremilast (PASI 75: 74%, PASI 90: 65%, PASI 100: >40% at week 24, p<0.0001).

• Rapid onset of action was observed, with PASI 90 responses emerging as early as week 4 and deepening through week 24.

• Clinically meaningful improvements in quality of life and itch were seen, with statistically significant NRS itch reduction.

• Safety profile was favorable and consistent with phase II; most adverse events were mild to moderate, transient, and manageable with standard therapy.

• No new safety signals were observed; most common adverse events included headache, nasopharyngitis, URTIs, and acne.

Competitive Landscape and Market Opportunity

• Envudeucitinib demonstrated skin clearance rates at or above those of leading oral and biologic therapies, with high efficacy, rapid onset, and oral convenience.

• The global psoriasis market is projected to reach $40 billion by 2030, with high-efficacy orals expected to drive growth and address significant unmet need.

• Most patients are undertreated, with only 8% receiving high-efficacy drugs; 75% of patients prefer oral therapies over biologics.

• Market research indicates that skin clearance, safety, and convenience are top priorities for both patients and physicians.

• High discontinuation rates for current orals highlight the need for better options.