— Preliminary Results from the Phase 1a Trial Anticipated by Year-End —
BOSTON, MA, USA I August 04, 2022 I Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced initiation of a Phase 1a clinical trial of STAR-0215 in healthy subjects. STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for hereditary angioedema (HAE), with dosing once every three months or longer. Astria anticipates preliminary results from the Phase 1a trial by year-end. The Phase 1a trial is intended to establish clinical proof of concept for the differentiated profile anticipated for STAR-0215.
“The initiation of the Phase 1a trial of STAR-0215 in healthy subjects is an important milestone for us, as it marks our progression to a clinical-stage company and is a critical next step towards our goal of improving the disease burden for people living with HAE,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are proud of our progress so far, and the initiation of our first clinical trial in HAE is a representation of our commitment to bringing hope with life-changing therapies to patients affected by rare diseases.”
The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 at a single U.S. center. Approximately 24 subjects will receive a single dose of STAR-0215 or placebo in at least three cohorts of 100mg, 300mg, and 600mg administered subcutaneously. The trial will assess safety and tolerability and aims to establish prolonged half-life and demonstrate inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism for STAR-0215 as a potential best-in-class treatment for HAE.
Preclinically, STAR-0215 has been shown to be a long-acting, potent, and selective inhibitor of plasma kallikrein. In a study conducted in cynomolgus monkeys, STAR-0215 showed rapid inhibition of plasma kallikrein after subcutaneous administration, and inhibition of high molecular weight kininogen cleavage was rapid and sustained throughout the entire 84-day dose-free period in the extended portion of the study. These preclinical data support the potential for once every three-month dosing.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Learn more about our company on our website, www.astriatx.com, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.
SOURCE: Astria Therapeutics
Post Views: 80
— Preliminary Results from the Phase 1a Trial Anticipated by Year-End —
BOSTON, MA, USA I August 04, 2022 I Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced initiation of a Phase 1a clinical trial of STAR-0215 in healthy subjects. STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for hereditary angioedema (HAE), with dosing once every three months or longer. Astria anticipates preliminary results from the Phase 1a trial by year-end. The Phase 1a trial is intended to establish clinical proof of concept for the differentiated profile anticipated for STAR-0215.
“The initiation of the Phase 1a trial of STAR-0215 in healthy subjects is an important milestone for us, as it marks our progression to a clinical-stage company and is a critical next step towards our goal of improving the disease burden for people living with HAE,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are proud of our progress so far, and the initiation of our first clinical trial in HAE is a representation of our commitment to bringing hope with life-changing therapies to patients affected by rare diseases.”
The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 at a single U.S. center. Approximately 24 subjects will receive a single dose of STAR-0215 or placebo in at least three cohorts of 100mg, 300mg, and 600mg administered subcutaneously. The trial will assess safety and tolerability and aims to establish prolonged half-life and demonstrate inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism for STAR-0215 as a potential best-in-class treatment for HAE.
Preclinically, STAR-0215 has been shown to be a long-acting, potent, and selective inhibitor of plasma kallikrein. In a study conducted in cynomolgus monkeys, STAR-0215 showed rapid inhibition of plasma kallikrein after subcutaneous administration, and inhibition of high molecular weight kininogen cleavage was rapid and sustained throughout the entire 84-day dose-free period in the extended portion of the study. These preclinical data support the potential for once every three-month dosing.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Learn more about our company on our website, www.astriatx.com, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.
SOURCE: Astria Therapeutics
Post Views: 80
