Astria Therapeutics Announces Successful Results from ALPHA-STAR Phase 1b/2 Trial of Navenibart for HAE
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical entity dedicated to creating transformative treatments for allergic and immunologic disorders, has reported encouraging final outcomes from the targeted enrollment cohort of 16 patients in the ALPHA-STAR Phase 1b/2 clinical investigation. This trial assesses navenibart (STAR-0215), a monoclonal antibody that acts as an inhibitor of plasma kallikrein, in individuals with hereditary angioedema (HAE). The final findings revealed a significant decrease in the average monthly attack rate of 90-95% over a six-month period, along with a favorable safety and tolerability profile. The results further support dosing regimens of every three months (Q3M) and every six months (Q6M). These outcomes highlight navenibart's potential to emerge as a leading therapy in the HAE market. Astria plans to progress navenibart into Phase 3 development, anticipating trial commencement in the first quarter of 2025.
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"The findings from the ALPHA-STAR Phase 1b/2 trial reinforce our confidence in navenibart’s effectiveness and its potential to become a transformative, leading preventative solution for patients with HAE," stated Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. "Following one or two doses over a six-month timeframe, patients showed a swift and significant onset of effective results, along with favorable safety and tolerability profiles, as well as pharmacokinetics (PK) and pharmacodynamics (PD) linked to ongoing plasma kallikrein inhibition with administration intervals of Q3M and Q6M. These outcomes align closely with the preliminary results we shared in March. We are eager to present this data at an upcoming scientific conference and aim to start Phase 3 development in the first quarter, pending the conclusion of discussions with global regulatory authorities."
"Results from the ALPHA-STAR trial are promising for the future of treating HAE," noted Dr. Aleena Banerji, Clinical Director at the MGH Allergy and Clinical Immunology Unit. "Insights from individuals living with HAE indicate that the disease and its treatments can significantly impact their physical and mental well-being. I am hopeful that a therapy characterized by infrequent dosing, good tolerability, and a reliable mechanism could help alleviate this burden for patients."
The ALPHA-STAR trial is a dose-ranging proof-of-concept study targeting adults with Type 1 or Type 2 HAE, aimed at evaluating safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and quality of life for patients receiving both single and multiple doses of navenibart in three subcutaneous cohorts designed to prevent HAE attacks. Each cohort commenced with an eight-week run-in phase to establish baseline attack levels, with safety, efficacy, PK, and PD being monitored up to six months (Day 168) post the last administered dose. Out of the target enrollment of 16 participants, 88% had Type 1 HAE, with an average age of 46, and 56% identified as female.
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According to the data provided by the Synapse Chemical, As of December 18, 2024, there are 34 investigational drugs for the KLKB1 target, including 27 indications, 37 R&D institutions involved, with related clinical trials reaching 78, and as many as 3725 patents.
Navenibart is a monoclonal antibody drug developed by Quellis Biosciences LLC, with its primary target being KLKB1. The drug is currently in the highest global phase of development, which is Phase 2. It is primarily intended for the treatment of Hereditary Angioedema, a rare genetic disorder that causes episodes of severe swelling in various parts of the body.
