Astria: ‘Positive’ initial proof-of-concept results from STAR-0215 for HAE trial

Astria Therapeutics announced positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 clinical trial evaluating STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema HAE patients. Initial results demonstrate a favorable safety and tolerability profile, mean monthly attack rate reduction of 90-96% for up to 6 months of follow up, and support both three- Q3M and six-month Q6M dosing regimens. Based on the positive results, Astria plans to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026. We are thrilled with these initial results from ALPHA-STAR and believe that STAR-0215 can be a transformative therapy for patients that greatly reduces their disease and treatment burdens,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “These results give us conviction that we will be able to deliver STAR-0215 once every three and six months, and we look forward to progressing this program into Phase 3 as quickly as possible.”…The company expects that its current cash, cash equivalents, and short-term investments of $246.5 M as of December 31, plus $137.1M from financing activity in the first quarter of 2024, will be sufficient to fund the Company into mid-2027 including all STAR-0215 program activities through the completion of a planned Q3M Phase 3 pivotal trial as well as advancing the Company’s STAR-0310 OX40 program through IND submission and early proof-of-concept results from a Phase 1a trial.