Alumis (ALMS) Study update summary

Study Overview and Design

• Envudeucitinib was evaluated in two global, randomized, double-blind, placebo- and active-controlled Phase III ONWARD trials for moderate-to-severe plaque psoriasis, with 2:1:1 randomization to envudeucitinib, placebo, or apremilast, and primary endpoints at week 16.

• Coprimary endpoints were PASI 75 and SPGA-0/1 at week 16 versus placebo; key secondary endpoints included PASI 90/100, itch reduction, scalp-specific PGA, and DLQI.

• The studies included over 1,700 patients, with balanced baseline demographics and a significant proportion having prior systemic therapy and substantial symptom burden.

• Patients completing week 24 could enter a long-term extension study (ONWARD3) to assess durability and long-term safety.

Efficacy Results

• At week 16, PASI 75 rates were 76.5% and 70.4%, and PASI 100 rates were near 30%; by week 24, PASI 90 rates reached 68.0% and 62.1%, and PASI 100 rates were 41.0% and 39.5%.

• Significant skin clearance and symptom improvements were observed as early as week 4, with continued deepening through week 24.

• Approximately 75% of patients achieved clear or almost clear scalp psoriasis by week 24.

• Quality-of-life and itch relief improvements emerged before PASI 90 responses and continued to improve through week 24.

• Nearly 30% of patients reported absence of psoriasis signs and symptoms (PSSD-0) at week 16, with continued improvement through week 24.

Patient-Reported Outcomes and Quality of Life

• Dramatic reductions in itch were seen, with average scores dropping from 6 to 1–1.7 by week 24, and improvements evident as early as two weeks.

• Over 60% of patients achieved a DLQI score of 0 or 1 by week 24, indicating no impact of psoriasis on quality of life.

• By week 12, about 50% of patients achieved minimal to no impact on quality of life (DLQI 0/1).

• Improvements in itch and quality of life preceded maximal skin clearance, highlighting early symptomatic benefit.