Astria Therapeutics Announces Positive Preliminary Results from the Phase 1a Clinical Trial of STAR-0215 in Healthy Subjects
— Shown Early Proof of Concept of STAR-0215’s Profile as a Long-Acting Plasma Kallikrein Inhibitor with Estimated Half-Life of Up to 110 Days —
— Plans to Initiate ALPHA-STAR Phase 1b/2 Trial in Hereditary Angioedema Patients in Q1 2023 —
Excerpt from the Press Release:
BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE), today announced positive preliminary results from the Phase 1a clinical trial of STAR-0215 in healthy subjects establishing early proof of concept of STAR-0215 as a potential long-acting preventative treatment for HAE. STAR-0215 was well-tolerated at all doses studied. The results showed rapid and sustained drug levels consistent with clinical benefit and sustained target engagement with plasma kallikrein inhibition for at least three months, supporting the potential for STAR-0215 to be dosed once every three months or less frequently. Astria plans to initiate the ALPHA-STAR Phase 1b/2 trial in HAE patients in Q1 2023.
“These results mark a significant milestone for STAR-0215 and Astria. We are excited that STAR-0215 has shown early proof of concept for its target profile: of being a long-acting preventative therapy for HAE, with a best-in-class PK profile, and dosing once every 3 months or less frequently,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria. “We aim to change the way those affected by HAE live with their disease and see these preliminary results as a critical step bringing us closer to improving patients’ lives. We are looking forward to bringing STAR-0215 to patients in the ALPHA-STAR trial early next year.”
“Patients want treatment options that can normalize their lives. I am pleased to see STAR-0215 moving forward in clinical development to patients,” said William Lumry, M.D., Founder and Medical Director of the AARA Research Center. “We understand the need from the HAE community for an effective treatment with less burdensome dosing administration and are excited to see that potential in STAR-0215.”
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