Astria Therapeutics announces positive final results from target enrollment in the ALPHA-STAR Phase 1b/2 trial of navenibart for HAE

Astra Therapeutics announced positive final results from the target enrollment group of 16 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. These final results demonstrated reduction in the mean monthly attack rate of 90-95% at 6 months, favorable safety and tolerability profile, and support both every three- (Q3M) and every six-month (Q6M) dosing regimens. Astria is advancing navenibart to Phase 3 development with trial initiation expected in Q1 2025.

Christopher Morabito MD, Chief Medical Officer at Astria Therapeutics, said: “The results from the ALPHA-STAR Phase 1b/2 trial affirm our belief in navenibart’s profile and its potential to be a life-changing preventative treatment for HAE patients. After one or two doses over six months, patients experienced rapid onset of robust and durable efficacy, favorable safety and tolerability, and PK and PD that are consistent with sustained plasma kallikrein inhibition and Q3M and Q6M administration. These results are highly consistent with the interim results we reported in March. We look forward to presenting these data at an upcoming scientific conference and expect to initiate Phase 3 development in Q1, pending completion of discussions with global regulators.”

Dr Aleena Banerji, Clinical Director, MGH Allergy and Clinical Immunology Unit, said: “These results from the ALPHA-STAR trial are exciting for the future of the HAE treatment landscape. We understand from people living with HAE that the disease and treatment burden can weigh heavily on their physical and mental health. I am optimistic that a therapy with infrequent dosing, a well-tolerated profile, and a trusted mechanism and modality could alleviate the burden for patients.”

(Source: Astria)