Alumis (ALMS) investor relations material

Key clinical trial insights

• Phase IIb trial of envudeucitinib in lupus did not meet primary or key secondary endpoints in the overall population due to a high proportion of interferon signature negative patients, diluting efficacy results.

• Strong and consistent treatment response observed in type 1 interferon signature positive patients across multiple endpoints, including BICLA, SRI-4, CLASI, joint counts, and remission.

• Placebo response was unusually high in signature negative patients, especially in the U.S., impacting trial outcomes.

• Consistent evidence across multiple programs suggests no benefit for interferon signature negative patients with this therapeutic approach.

• Future trials will focus on enriching for signature positive patients and exploring additional biomarkers for response.

Regulatory and development strategy

• Plans to engage with the FDA by late 2024 or early 2025 to discuss a phase III trial focused on interferon signature positive lupus patients.

• Considering trial designs that may include a small signature negative cohort for supportive analysis, but primary focus will be on signature positive population.

• Potential for regulatory flexibility based on robust phase II data, but final requirements will depend on agency discussions.

• Communication strategy for next steps is still under consideration, pending further internal and regulatory review.

Expansion and future indications

• Strong efficacy on skin endpoints (CLASI) increases confidence in developing envudeucitinib for cutaneous lupus erythematosus (CLE), with similar biomarker considerations as SLE.

• Sjögren's syndrome development is more exploratory, awaiting external validation from other TYK2 trials.

• Additional analysis of RNA samples from the trial may identify further predictive biomarkers.