— Phase 1a Trial of STAR-0310 in Healthy Volunteers Expected to Initiate in Q1 2025 —
— Early Proof-of-Concept Results Expected in Q3 2025 —
BOSTON, MA, USA I December 08, 2024 I Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist, the company is developing as a potential treatment for atopic dermatitis (AD) and potentially other indications. A Phase 1a trial of STAR-0310 in healthy subjects is expected to initiate in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, the company anticipates proof-of-concept results in atopic dermatitis patients in the second quarter of 2026.
“We are pleased with the FDA’s acceptance of our IND application for STAR-0310 and the progress it represents for the program,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are very excited about the potential for the OX40 mechanism. With the goal of creating the overall best OX40 program, we intentionally have designed STAR-0310 to capitalize on the learnings of OX40 receptor and OX40 ligand programs. STAR-0310’s high affinity and high potency in conjunction with low ADCC has the potential to enable a wider therapeutic window, and additionally, STAR-0310 has the potential to be dosed as infrequently as every six months due to its long half-life and potential for disease modification.”
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 preclinical 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
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— Phase 1a Trial of STAR-0310 in Healthy Volunteers Expected to Initiate in Q1 2025 —
— Early Proof-of-Concept Results Expected in Q3 2025 —
BOSTON, MA, USA I December 08, 2024 I Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist, the company is developing as a potential treatment for atopic dermatitis (AD) and potentially other indications. A Phase 1a trial of STAR-0310 in healthy subjects is expected to initiate in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, the company anticipates proof-of-concept results in atopic dermatitis patients in the second quarter of 2026.
“We are pleased with the FDA’s acceptance of our IND application for STAR-0310 and the progress it represents for the program,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are very excited about the potential for the OX40 mechanism. With the goal of creating the overall best OX40 program, we intentionally have designed STAR-0310 to capitalize on the learnings of OX40 receptor and OX40 ligand programs. STAR-0310’s high affinity and high potency in conjunction with low ADCC has the potential to enable a wider therapeutic window, and additionally, STAR-0310 has the potential to be dosed as infrequently as every six months due to its long half-life and potential for disease modification.”
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 preclinical 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: 2,477
