Astria Therapeutics Announces Final Positive Results from All Enrolled HAE Patients in the ALPHA-STAR Phase 1b/2 Trial of Navenibart

— Final ALPHA-STAR Phase 1b/2 Results from the Full-Enrollment Population (n=29) Remain Highly Consistent with Prior Results from the Target-Enrollment Population (n=16), Demonstrating Strong Efficacy, Favorable Safety, and Potential for Infrequent Dosing —

— Phase 3 ALPHA-ORBIT Trial for Navenibart is Progressing as Planned with Topline Results Anticipated in Early 2027; First Patient Now Enrolled in the ORBIT-EXPANSE Long-Term Extension Trial —

Excerpt from the Press Release:

BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive results from the full enrollment group of 29 patients in the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. Conducted across 20 sites in six countries, the trial demonstrated robust attack rate reduction, along with a favorable safety and tolerability profile, supporting both every three-month (Q3M) and every six-month (Q6M) dosing regimens. These results reinforce the potential of navenibart’s profile to provide effective, long-acting prevention from HAE attacks and highlight Astria’s strong global clinical execution as the Phase 3 program progresses, with topline results expected in early 2027.

“The updated results from the full 29 patients in the ALPHA-STAR Phase 1b/2 trial are highly encouraging and reinforce our confidence in navenibart’s profile as a potentially life-changing preventative treatment for HAE,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics.

Click the button below to read the entire Press Release:

Continue Reading The Press Release