Alumis Announces First Participant Dosed in Phase 1 Clinical Trial of CNS Penetrant Allosteric TYK2 Inhibitor A-005
April 30 2024 - 8:00AM
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-005A-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 DahlmanRed House Communicationsteri@redhousecomms.com