Alumis Presents Data Highlighting the Potential of ESK-001 as a High-Efficacy Oral Treatment for Systemic Lupus Erythematosus (SLE) at ACR Convergence 2024

SOUTH SAN FRANCISCO, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and dramatically improve lives patients. with immune-mediated diseases, today announced that the company will make two data presentations at ACR Convergence 2024, the annual meeting of the American College of Rheumatology (ACR), to be held November 14-19, 2024 in Washington, DC.

Data to be presented at ACR shows that treatment with ESK-001, a highly selective oral allosteric tyrosine kinase 2 (TYK2) inhibitor, suppresses both a novel disease biomarker as well as type 1 interferons , known key factors of LED. Additionally, leveraging its proprietary data analysis platform, Alumis has identified novel pathways involved in SLE that can be suppressed by TYK2 inhibition.

“ACR data show that ESK-001 treatment downregulates key cytokines and pathological biomarkers in SLE,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. “These data, along with the demonstrated ability of ESK-001 to achieve maximal TYK2 inhibition in psoriasis, suggest that ESK-001 could potentially become a highly effective oral treatment option for patients with SLE. Our team continues to advance the LUMUS Phase 2b study in LED, and we look forward to publishing topline data in 2026.”

Details regarding the presentations are as follows:

POSTER PRESENTATION:

Title: Novel role of TYK2 mechanism in SLE pathogenesis via T and B cell pathways

Session title: Genetics, Genomics and Proteomics Poster

Type of session: Poster session B

Date and time: Sunday, November 17, 2024, 10:30 a.m. – 12:30 p.m. EST

Summary number: 0902

POSTER PRESENTATION:

Title: ESK-001, an allosteric TYK2 inhibitor, maximally suppresses type 1 interferon, a therapeutic pathway central to SLE and CLE

Session title: LED – Treatment Poster III

Type of session: Poster Session C

Date and time: Monday, November 18, 2024, 10:30 a.m. – 12:30 p.m. EST

Summary number: 2434

The presentations will be available in the Publications section of the Alumis website on November 18, 2024.

About SLE (lupus)

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease and is the most common type of lupus. Lupus occurs when the immune system attacks its own tissues, causing inflammation and, in some cases, permanent tissue damage, which can be widespread – affecting many parts of the body such as the skin, joints, heart, lungs, kidneys, circulating blood cells and brain. Current treatments aim to relieve lupus symptoms or reduce inflammation to minimize organ damage; there is no cure for lupus.

About the ESK-001

Alumis’ lead clinical candidate, ESK-001, is a potent and highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor that reduces signaling through multiple cytokine receptors, including interleukin (IL)-12 receptors , IL-23 and interferon-a.

ESK-001 is currently being evaluated in the Phase 2 LUMUS clinical trial, a global, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and pharmacokinetics of multiple doses of ESK-001 in adults. patients with moderately to severely active autoantibody-positive SLE. The trial is expected to enroll 388 patients receiving multiple doses of ESK-001 or placebo over a 48-week treatment period. After the trial, eligible patients can enroll in an open-label extension study or participate in a four-week safety follow-up period. The primary endpoint of the trial will compare the proportion of patients with improvement in BICLA at week 48 from baseline between doses of ESK-001 and placebo. The British-Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) is an accepted composite measure of overall SLE activity. Secondary endpoints include safety and tolerability, as well as various measures of effect on disease activity. For more information, visit clinical trials.gov.

ESK-001 is also currently being evaluated as a potential treatment for adult patients with moderate to severe plaque psoriasis in the ONWARD Phase 3 clinical program which consists of two identical, multicenter, randomized, duplicate, global Phase 3 placebo tests. blind. 24-week controlled clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of the 40 mg twice daily dose of ESK-001. Patients completing week 24 will have the opportunity to participate in a long-term extension (LTE) trial, ONWARD3, which will evaluate durability and maintenance of response and long-term safety. In conjunction with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 that can replace the current immediate-release oral formulation, administered twice daily.

Phase 3 clinical program in moderate to severe plaque psoriasis is supported by positive data from the Phase 2 STRIDE clinical trial in which 228 patients were randomized to one of five dose cohorts of ESK-001 or in a placebo. The trial met its primary endpoint of proportion of patients achieving PASI 75 at week 12 compared to placebo, as well as key secondary endpoints of efficacy at all clinically relevant doses tested. Clear dose-dependent responses were observed with maximum efficacy and TYK2 inhibition achieved at the highest dose of 40 mg twice daily. ESK-001 was generally well tolerated at all dose levels.

Additionally, Alumis continues to leverage its precision data analytics platform to explore the potential application of ESK-001 in other autoimmune indications.

About Alumis

Alumis is a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases. Leveraging its proprietary precision data analysis platform, Alumis is building a pipeline of molecules with the potential to treat a broad range of immune-mediated diseases as monotherapy or combination therapies. Alumis’ most advanced product candidate, ESK-001, is an oral, highly selective, small molecule allosteric inhibitor of tyrosine kinase 2, which is currently being evaluated for the treatment of patients with plaque psoriasis moderate to severe and systemic lupus erythematosus. Alumis is also developing A-005, a CNS-penetrating allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary precision data analysis platform and drug discovery expertise has led to the identification of additional preclinical programs that exemplify its precision approach. Incubated by Foresite Labs and led by a team of industry veterans experienced in developing small molecule drugs for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially produce the next generation of treatments to combat immune dysfunction. For more information, visit

Forward-looking statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims”, “anticipates” , “believes”, “could”, “estimates”, “expects”, “forecasts”, “objective”, “intends”, “may”, “plans”, “possible”, “potential” , “seeks”, “will” and their variations. similar words or expressions intended to identify forward-looking statements. All statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. These forward-looking statements include, without limitation, statements regarding Alumis’ future plans and prospects, the potential of ESK-001 as a high-efficacy oral treatment in systemic lupus erythematosus, any other expectations regarding safety , the effectiveness or tolerability of ESK. -001, and the expected timeline of clinical data, including data from Alumis’ ongoing Phase 2b SLE trial. Any forward-looking statements contained in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this press release and are subject to a number of risks and uncertainties which could cause the actual results differ materially and adversely from those. stated or implied in these forward-looking statements. Readers are cautioned that actual results, activity levels, safety, effectiveness, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety risks and uncertainties, which include, but are not limited to, risks and uncertainties relating to Alumis’ ability to advance ESK-001 and its other clinical candidates and obtain regulatory approval and, ultimately, to commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to finance development activities and achieve development objectives, Alumis’ ability to protect its intellectual property and other risks and uncertainties described in Alumis’ filings with the Securities and Exchange Commission (SEC), including any future reports that Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements, except as required by law.

CONTACT: Alumis contact details

Teri Dahlman

Communications from the Red House

(email protected)