BOSTON - Astria Therapeutics, Inc. (NASDAQ:ATXS) has announced positive initial results from its ALPHA-STAR Phase 1b/2 clinical trial for STAR-0215, a potential treatment for hereditary angioedema (HAE). The trial data suggests a significant reduction in monthly attack rates and a strong safety profile, with plans to initiate Phase 3 trials in early 2025.
STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, showed a 90-96% reduction in monthly HAE attack rates over a six-month follow-up period. The trial also reported a 92-100% decrease in moderate or severe attacks and a 91-95% reduction in attacks requiring rescue medications. Notably, 50-67% of patients in different cohorts were attack-free for extended periods.
The treatment was well-tolerated with no serious adverse events or discontinuations reported. Only two mild treatment-emergent adverse events were noted, including dizziness and a transient injection site reaction.
Astria's Chief Medical Officer, Christopher Morabito, M.D., expressed confidence in the potential of STAR-0215 to transform HAE patient care by reducing disease and treatment burdens. The trial's results have reinforced the company's plans to pursue a Phase 3 development program, with expectations to deliver dosing regimens every three to six months.
Following the ALPHA-STAR trial, participants will have the opportunity to continue receiving STAR-0215 in the long-term ALPHA-SOLAR trial, with initial safety and efficacy data anticipated by mid-2025.
The company's current financial position, with cash, cash equivalents, and short-term investments totaling $246.5 million as of December 31, 2023, alongside $137.1 million from first-quarter 2024 financing activities, is expected to fund operations into mid-2027. This includes the completion of the planned Phase 3 pivotal trial for STAR-0215 and early-stage trials for another program, STAR-0310.
Astria Therapeutics is dedicated to developing therapies for allergic and immunological diseases, with STAR-0215 as its lead program for HAE and STAR-0310 for atopic dermatitis in preclinical development.
The information in this article is based on a press release statement from Astria Therapeutics.
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