Alumis Announces First Participant Dosed in Phase 1 Clinical Trial of CNS Penetrant Allosteric TYK2 Inhibitor A-005

– A-005 is a potential first-in-class, CNS penetrant TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases –

– Phase 1 clinical trial supported by preclinical profile demonstrating high potency, selectivity, and ability to cross the blood brain barrier and reduce neuroinflammation –

SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) — Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced that dosing has commenced in a Phase 1 clinical trial of A-005 in healthy participants. A-005 is a potential first-in-class, central nervous system (CNS) penetrant tyrosine kinase 2 (TYK2) inhibitor being developed for the treatment of neuroinflammatory and neurodegenerative diseases, with potential application in diseases such as multiple sclerosis and Parkinson’s Disease. The Phase 1 clinical trial is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple-ascending orally administered doses of A-005 in healthy volunteers, including confirmation of CNS penetration in humans.

“Supported by promising preclinical data, this clinical trial in healthy volunteers is a critical step toward our goal of further validating the role of TYK2 in diseases of the central nervous system, where we believe this highly potent and selective mechanism could have a meaningful impact for patients,” said Dr. Jörn Drappa, Alumis’ Chief Medical Officer. “We believe Alumis has made significant progress advancing our first TYK2 inhibitor, ESK-001, in multiple autoimmune indications, and we are now pleased to share this important milestone of advancing our second TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases.”

In preclinical studies, A-005 demonstrated the ability to significantly reduce clinical scores in experimental autoimmune encephalomyelitis (EAE), a preclinical model of neuroinflammation, when administered prophylactically or therapeutically, and to efficiently cross the blood brain barrier with a blood-to-brain ratio of approximately 1:1.

About A-005
A-005 is a potential first-in-class CNS penetrant tyrosine kinase 2 (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. TYK2 is a member of the Janus kinase (JAK) family of proteins and mediates signaling responses to key proinflammatory cytokines, including interleukin (IL)-23, IL-12 and interferon-alpha (IFNα). TYK2 inhibition has been clinically validated in autoimmune conditions, and Alumis’ data analytics support a genetic rationale for TYK2 inhibition as a novel approach in diseases of the central nervous system.

About Alumis
Alumis is a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize outcomes and transform the lives of patients with immune-mediated diseases. Leveraging its precision data analytics and a multi-platform approach, Alumis is advancing a pipeline of oral therapies designed to address immune dysfunction. Alumis’ lead product candidate ESK-001 is a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor that is currently being evaluated for the treatment of patients with moderate to severe plaque psoriasis, systemic lupus erythematosus (SLE), and non-infectious uveitis. Alumis is also developing A-005, a potential first-in-class CNS penetrant allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases in an ongoing Phase 1 clinical trial. Alumis also has discovery efforts in undisclosed immune-mediated diseases and targets identified by its data analytics platform. Incubated by Foresite Labs and led by a team of experts with deep experience and proven track records in drug discovery, development and immunology, Alumis is developing transformative therapies that aim to reimagine the lives of people with immune-mediated diseases. For more information, please visit alumis.com.

Alumis Contact Information

Teri Dahlman
Red House Communications
teri@redhousecomms.com