Boston– Astria Therapeutics announced that data from its Phase 1a clinical trial evaluating navenibart in healthy subjects has been published in the Annals of Allergy, Asthma & Immunology, highlighting the investigational therapy’s potential as a long-acting preventive treatment for hereditary angioedema (HAE).
The published results support the company’s view that navenibart, which targets plasma kallikrein, could offer safe and effective HAE attack prevention with dosing intervals of every three to six months. Navenibart is currently being evaluated in the ongoing Phase 3 ALPHA-ORBIT trial.
“We are thrilled by our publication in the Annals and the opportunity to share data that affirm our belief in navenibart’s potential to become the first-choice therapy for HAE,” said Dr. Christopher Morabito, Chief Medical Officer at Astria Therapeutics. “The Phase 1a trial laid the foundation for our pivotal Phase 3 study, which is now enrolling globally.”
According to the company, the Phase 1a trial demonstrated that navenibart had a favorable safety profile, with no serious adverse events reported and similar rates of mild adverse events between treatment and placebo groups. The drug showed statistically significant inhibition of plasma kallikrein activity compared to placebo, and its mean half-life ranged from 82 to 105 days at doses of 300 mg or higher—findings that support the feasibility of infrequent dosing.
Astria is positioning navenibart as a potentially life-changing therapy for HAE, a rare genetic disorder that causes recurrent swelling episodes and significantly impacts quality of life. The company anticipates that if successful in later-stage trials, navenibart could become a preferred option for long-term HAE management.
