ALMS Alumis Inc

Alumis Inc. (Nasdaq: ALMS) (“Alumis” or the “Company”), 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, today announced the Company will give two data presentations on A-005, a potent, selective, central nervous system (CNS) penetrant tyrosine kinase 2 (TYK2) inhibitor, on Friday, February 28, 2025, at the 10th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025.

“These data demonstrate that A-005 potently inhibits TYK2-specific signaling in immune cells and CNS resident cells, targeting pro-inflammatory cytokine pathways implicated in the pathology of neuroinflammatory diseases,” said Jörn Drappa, M.D., Alumis’ Chief Medical Officer. “As the first reported allosteric TYK2 inhibitor with demonstrated ability to cross the blood-brain barrier, A-005 represents a novel approach to potentially treating a broad range of diseases associated with CNS inflammation.”

Dr. Drappa added, “The Phase 1 clinical data demonstrate that A-005 was well tolerated and achieved maximal TYK2 inhibition across a broad dose range. These data support our plans to commence a Phase 2 clinical trial in patients with multiple sclerosis in the second half of this year.”

Details regarding the February 28, 2025, presentations are as follows: 

Title: A-005, a Selective Oral Brain Penetrant TYK2 Inhibitor, Modulates Astrocytes and Microglia Poster Number: P352Time: 6:00 PM – 6:45 PM ET

Title: Safety, Tolerability, and Pharmacokinetics of A-005: A Selective Brain-Penetrant TYK2 Inhibitor for CNS Inflammatory Diseases in Healthy Volunteers Following Single and Multiple Ascending DosesPoster Number: P335Time: 6:45 PM – 7:30 PM ET

The ACTRIMS Forum 2025 posters will be made available in the Publications section of the Alumis website on February 28, 2025 concurrent with the presentations.

About the A-005 Phase 1 Clinical TrialThe Phase 1 clinical trial evaluated the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-ascending doses of A-005 in 135 healthy participants. The trial included a single-ascending dose (SAD) portion which evaluated ten dose cohorts, a 14-day multiple-ascending (MAD) dose portion which evaluated five dose cohorts (n=8, 6 active, 2 placebo) and a single dose cohort which included a lumbar puncture to assess A-005 concentrations in the CSF. For the SAD and MAD portions of the study, pharmacodynamic (PD) markers (including pSTAT levels) were measured to establish a PK/PD relationship.

About A-005A-005 is a potential first-in-class CNS-penetrant allosteric TYK2 inhibitor being developed for the treatment of neuroinflammatory and neurodegenerative diseases such as multiple sclerosis and Parkinson’s Disease. A-005 is designed to achieve maximal TYK2 inhibition and to cross the blood brain barrier for localized treatment both within the CNS and in the periphery, supporting its potential across multiple TYK2-mediated indications. TYK2 is a protein that plays a role in mediating signaling responses to key proinflammatory cytokines, including interleukin (IL)-23 and type 1 interferon. A-005 completed a Phase 1 clinical trial in healthy participants and is expected to enter a Phase 2 clinical trial in patients with multiple sclerosis in the second half of 2025.

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 analytics platform, Alumis is building a pipeline of molecules with the potential to address 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 TYK2 that is currently being evaluated for the treatment of patients with moderate-to-severe plaque psoriasis and systemic lupus erythematosus. Alumis is also developing A-005, a clinical-stage, CNS-penetrant, allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary precision data analytics platform and drug discovery expertise have 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 small-molecule compound drug development for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially produce the next generation of treatment to address immune dysfunction. For more information, visit www.alumis.com.

Forward-Looking StatementsThis 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," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding Alumis’ future plans and prospects including development and commercialization of its pipeline, the timing and initiation of Alumis’ planned Phase 2 clinical trial in MS, any expectations regarding the safety, efficacy or tolerability of A-005, the potential of ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and the potential of A-005 to be a first-in-class treatment for neurodegenerative diseases, including a broad range of diseases associated with CNS inflammation. 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 A-005 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.

Alumis Contact Information
Teri Dahlman
Red House Communications
teri@redhousecomms.com