Alumis Showcases Promising Oral SLE Treatment ESK-001 at ACR Convergence 2024

On November 14, 2024, Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical firm focusing on oral therapies aimed at improving outcomes for patients with immune-mediated diseases, announced plans to present data at ACR Convergence 2024, the annual meeting of the American College of Rheumatology (ACR). The conference will take place in Washington, D.C. from November 14 to 19, 2024.

Alumis will present findings on ESK-001, an advanced, selective oral tyrosine kinase 2 (TYK2) inhibitor. The data shows that ESK-001 effectively suppresses a new disease biomarker and Type 1 interferons, which are key contributors to systemic lupus erythematosus (SLE). Utilizing its proprietary data analytics platform, Alumis has uncovered previously unknown pathways in SLE that can also be targeted by TYK2 inhibition.

Dr. Jörn Drappa, the Chief Medical Officer of Alumis, commented on the results, noting that ESK-001 significantly reduces critical cytokines and biomarkers associated with SLE. ESK-001 has shown the ability to achieve optimal TYK2 inhibition in psoriasis, indicating its potential as a highly effective oral treatment for SLE. Alumis is progressing with the Phase 2b LUMUS study in SLE and plans to release top-line data in 2026.

The details of the poster presentations at ACR Convergence 2024 are as follows:

1. **Poster Presentation:**
- **Title:** Novel Role of TYK2 Mechanism in SLE Pathogenesis via T Cell and B Cell Pathways
- **Session Title:** Genetics, Genomics & Proteomics Poster
- **Date and Time:** Sunday, November 17, 2024, 10:30 a.m. – 12:30 p.m. EST
- **Abstract Number:** 0902

2. **Poster Presentation:**
- **Title:** ESK-001, an Allosteric TYK2 Inhibitor, Maximally Suppresses Type 1 Interferon, a Therapeutic Pathway Central to SLE and CLE
- **Session Title:** SLE – Treatment Poster III
- **Date and Time:** Monday, November 18, 2024, 10:30 a.m. – 12:30 p.m. EST
- **Abstract Number:** 2434

The presentations will be available on the Alumis website on November 18, 2024.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease and the most prevalent form of lupus. It occurs when the immune system attacks the body's tissues, causing inflammation and sometimes irreversible tissue damage. Lupus can affect various parts of the body, including the skin, joints, heart, lungs, kidneys, blood cells, and brain. Current treatments mainly focus on relieving symptoms or reducing inflammation to prevent organ damage, but there is no cure.

Alumis' leading clinical candidate, ESK-001, is a highly selective allosteric TYK2 inhibitor that modulates signaling through several cytokine receptors, including those for interleukin (IL)-12, IL-23, and interferon-alpha. ESK-001 is currently being tested in the Phase 2 LUMUS clinical trial, which is a global, multicenter, randomized, double-blind, placebo-controlled study. This trial aims to assess the efficacy, safety, and pharmacokinetics of multiple doses of ESK-001 in adult patients with moderately to severely active autoantibody-positive SLE. The trial will include 388 patients and last for 48 weeks, with further options for an open-label extension or a four-week safety follow-up period. The primary endpoint will evaluate the proportion of patients showing improvement in the BICLA at Week 48 compared to the baseline.

In addition to SLE, ESK-001 is under evaluation for moderate-to-severe plaque psoriasis in the Phase 3 ONWARD clinical program. This program comprises two identical global Phase 3 trials, ONWARD1 and ONWARD2, which are designed to assess the efficacy and safety of ESK-001 at a 40 mg twice-daily dosage over 24 weeks. Patients who complete the 24-week period can participate in a long-term extension trial, ONWARD3. The Phase 3 trials are supported by positive results from the Phase 2 STRIDE clinical trial, which showed significant efficacy and safety at all tested doses.

Alumis continues to utilize its precision data analytics platform to explore additional applications for ESK-001 in other autoimmune diseases. The company, which specializes in developing oral therapies to enhance clinical outcomes for immune-mediated diseases, is also investigating a once-daily modified release formulation of ESK-001 and other potential treatments for various immune disorders.