Astria Therapeutics Announces Positive Initial Results from the ALPHA-SOLAR Long-Term Open-Label Trial of Navenibart in Hereditary Angioedema Patients at the European Academy of Allergy and Clinical Immunology Annual Congress

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. These results demonstrated robust overall reduction in the monthly attack rate (92% mean and 97% median). These results further support navenibart’s favorable safety and tolerability profile, and potential every three- (Q3M) and every six-month (Q6M) dosing regimens.

“We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “Results are consistent with navenibart’s best-in-class profile that we saw in the ALPHA-STAR Phase 1b/2 trial. With now 12 to 18 months on navenibart, these ALPHA-SOLAR results support navenibart’s favorable profile and the potential to administer navenibart every 3 and every 6 months. The Phase 3 ALPHA-ORBIT trial is evaluating both every 3- and every 6-month regimens and is actively enrolling patients. Navenibart’s profile and results that we have seen to date demonstrate the potential for navenibart to be the market-leading HAE therapy.”

“The navenibart results in patients to date support the potential for patients to have long-acting protection from their HAE attacks with very low treatment burden,” said Dr. William Yang, M.D., PRCPC, FAAAAI, Chair, Ottawa Allergy Research Corporation and Red Maple Trials Inc. “We are excited for the Phase 3 ALPHA-ORBIT trial and believe that navenibart’s profile with infrequent dosing could allow patients to spend less time thinking about their HAE, and more time living their lives.”

ALPHA-SOLAR is a long-term open-label trial in adults with HAE Type 1 or 2 designed to assess long-term safety and efficacy of navenibart. All 16 target enrollment participants from the Phase 1b/2 ALPHA-STAR trial elected to enroll in ALPHA-SOLAR. ALPHA-STAR patients from Cohorts 1 and 2 enrolled in Arm A, and ALPHA-STAR patients from Cohort 3 enrolled in Arm B (described in the table below).

Initial results from ALPHA-SOLAR¹:

Mean / Median Reduction in Monthly Attack Rate

Mean / Median Reduction in Moderate and Severe Monthly Attack Rate