Alumis Showcases Efficacy of ESK-001 for SLE at ACR Convergence 2024

On November 14, 2024, Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company focused on developing oral therapies for immune-mediated diseases, announced that it will present two sets of data at the American College of Rheumatology (ACR) Convergence 2024, taking place from November 14–19, 2024, in Washington, D.C.

The data to be presented highlights the efficacy of ESK-001, a highly selective oral tyrosine kinase 2 (TYK2) inhibitor. According to the findings, ESK-001 effectively suppresses a novel disease biomarker and Type 1 interferons, which are key drivers of systemic lupus erythematosus (SLE). Alumis has utilized its proprietary data analytics platform to uncover new pathways involved in SLE that can be targeted through TYK2 inhibition.

Dr. Jörn Drappa, Chief Medical Officer of Alumis, noted that the data indicates ESK-001's potential to downregulate critical cytokines and biomarkers associated with SLE. Given its ability to achieve maximal TYK2 inhibition in psoriasis, ESK-001 could emerge as a potent oral treatment option for SLE patients. The company is actively advancing the Phase 2b LUMUS study in SLE and anticipates reporting top-line data in 2026.

The presentations at ACR Convergence 2024 are scheduled 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
- Session Type: Poster Session B
- 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
- Session Type: Poster Session C
- Date and Time: Monday, November 18, 2024, 10:30 a.m. – 12:30 p.m. EST
- Abstract Number: 2434

The presentations will be accessible on the Alumis website under the Publications section from November 18, 2024.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease where the immune system attacks the body's tissues, leading to inflammation and potential permanent damage. This can affect multiple organs, including the skin, joints, heart, lungs, kidneys, blood cells, and brain. Current treatments primarily aim to alleviate symptoms or reduce inflammation to prevent organ damage, as there is no cure for lupus.

Alumis' leading clinical candidate, ESK-001, is a potent and selective allosteric TYK2 inhibitor that reduces signaling through several cytokine receptors, such as those for IL-12, IL-23, and interferon-a. ESK-001 is being evaluated in the Phase 2 LUMUS trial, which is a global, multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and pharmacokinetics of multiple doses in adult patients with moderately to severely active, autoantibody-positive SLE. This trial aims to enroll 388 patients over a 48-week treatment period. Eligible patients post-trial may join an open-label extension study or undergo a four-week safety follow-up. The primary endpoint is the improvement in BICLA at Week 48 compared to the baseline.

Additionally, ESK-001 is under evaluation in the Phase 3 ONWARD clinical program for moderate-to-severe plaque psoriasis. This program includes two identical 24-week trials (ONWARD1 and ONWARD2) and a long-term extension trial (ONWARD3) to assess the long-term safety and maintenance of response. Positive Phase 2 STRIDE trial data supports these Phase 3 trials.

Alumis continues to leverage its precision data analytics platform to explore ESK-001’s potential for other autoimmune indications. The company aims to develop innovative therapies for immune-mediated diseases with a precision-focused approach.