— Early Proof-of-Concept Results from the Phase 1a Trial Anticipated in Q3 2025 —
BOSTON, MA, USA I January 23, 2025 I Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced initiation of a Phase 1a clinical trial of STAR-0310 in healthy subjects. STAR-0310, a high affinity monoclonal antibody OX40 antagonist that incorporates YTE technology, is in development for the potential treatment of atopic dermatitis (AD) and potentially other indications. The Phase 1a trial is intended to assess the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants. Astria expects early proof-of-concept results from the Phase 1a trial in the third quarter of 2025.
“The Phase 1a trial of STAR-0310 in healthy subjects is an important opportunity for us to clinically differentiate the profile of STAR-0310,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “We believe STAR-0310 will be the best-in-class therapy due to efficacy, safety and tolerability, and treatment burden, and could transform lives for many people living with moderate-to-severe AD.”
The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in approximately 40 healthy adult participants.
Preclinical results support the potential for STAR-0310 to have the best-in-class OX40 inhibitor profile. By design, there is significantly less antibody-dependent cellular cytotoxicity (ADCC) with STAR-0310 compared to rocatinlimab, an OX40 antagonist currently in Phase 3 development for the treatment of AD. Reduction in ADCC activity has the potential for a more favorable safety profile and potentially wider therapeutic window for STAR-0310, which we believe provides the potential to drive more efficacy. STAR-0310 exhibits a long mean half-life of 26 days in cynomolgus monkeys, compared to 10-14 days in a typical non-half-life extended IgG1 antibody, and has comparable potency to rocatinlimab.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on Instagram @AstriaTx and on Facebook and LinkedIn.
SOURCE: Astria Therapeutics
Post Views: 79
— Early Proof-of-Concept Results from the Phase 1a Trial Anticipated in Q3 2025 —
BOSTON, MA, USA I January 23, 2025 I Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced initiation of a Phase 1a clinical trial of STAR-0310 in healthy subjects. STAR-0310, a high affinity monoclonal antibody OX40 antagonist that incorporates YTE technology, is in development for the potential treatment of atopic dermatitis (AD) and potentially other indications. The Phase 1a trial is intended to assess the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants. Astria expects early proof-of-concept results from the Phase 1a trial in the third quarter of 2025.
“The Phase 1a trial of STAR-0310 in healthy subjects is an important opportunity for us to clinically differentiate the profile of STAR-0310,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “We believe STAR-0310 will be the best-in-class therapy due to efficacy, safety and tolerability, and treatment burden, and could transform lives for many people living with moderate-to-severe AD.”
The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in approximately 40 healthy adult participants.
Preclinical results support the potential for STAR-0310 to have the best-in-class OX40 inhibitor profile. By design, there is significantly less antibody-dependent cellular cytotoxicity (ADCC) with STAR-0310 compared to rocatinlimab, an OX40 antagonist currently in Phase 3 development for the treatment of AD. Reduction in ADCC activity has the potential for a more favorable safety profile and potentially wider therapeutic window for STAR-0310, which we believe provides the potential to drive more efficacy. STAR-0310 exhibits a long mean half-life of 26 days in cynomolgus monkeys, compared to 10-14 days in a typical non-half-life extended IgG1 antibody, and has comparable potency to rocatinlimab.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on Instagram @AstriaTx and on Facebook and LinkedIn.
SOURCE: Astria Therapeutics
Post Views: 79
