-Topline Readout Expected in Q3 2026-
SOUTH SAN FRANCISCO, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its global LUMUS Phase 2b trial of ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for the treatment of systemic lupus erythematosus (SLE), the most common form of lupus.
"Completion of enrollment in our global LUMUS Phase 2b trial for SLE marks a significant milestone for Alumis, and importantly, for the lupus community," said Martin Babler, President and Chief Executive Officer of Alumis. "This achievement reflects the dedication of our clinical partners, investigators, patients, and the entire Alumis team, positioning us to share topline data in the third quarter of 2026."
"People living with SLE face a heavy burden and few treatment options," added Dr. Jörn Drappa, Alumis' Chief Medical Officer. "ESK-001, our next-generation oral TYK2 inhibitor, is designed to change that-selectively targeting key inflammatory drivers like type 1 IFN to maximize inhibition while minimizing off-target binding and effects. Clinical data in our psoriasis program has demonstrated that ESK-001 achieved full, sustained target inhibition and was generally well tolerated, positioning it as a promising oral therapy with potential for biologic-like clinical responses."
The global LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 in adults with moderately-to-severely active, autoantibody-positive SLE. The trial enrolled 408 patients who are receiving ESK-001 or placebo for 48 weeks. The primary endpoint will be to assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48. After the trial, eligible patients may participate in an open-label extension or complete a four-week safety follow-up.
About ESK-001
ESK-001 is a highly selective, next-generation oral TYK2 inhibitor designed to correct immune dysregulation across a range of diseases, including SLE, the most common form of lupus. By selectively targeting key proinflammatory mediators, including type 1 interferon (IFN), it aims to deliver maximal inhibition while minimizing off-target effects.
Clinical data in Alumis' psoriasis program indicates that ESK-001 downregulates key cytokines and disease biomarkers relative to SLE, disrupting pro-inflammatory pathways which Alumis believes may have the potential to reduce SLE disease activity. In Phase 1 studies, it demonstrated full, sustained target inhibition and was well tolerated in healthy volunteers. These data, along with ESK-001's ability to achieve maximal TYK2 inhibition in patients with psoriasis, suggest it could become a potential oral treatment with biologic-like clinical response rates for SLE.
The global LUMUS Phase 2b trial (NCT05966480) is evaluating multiple doses of ESK-001 in adults with moderately-to-severely active, autoantibody-positive SLE. The randomized, double-blind, placebo-controlled study enrolled 408 patients, with topline data expected in the third quarter of 2026.
The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis is currently being evaluated in the Phase 3 ONWARD clinical program. Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential applications in other immune-mediated conditions.
About Alumis
Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti-insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including 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," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its LUMUS Phase 2b program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, 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 Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
