Astria Therapeutics Launches Global Phase 3 Trial for Navenibart in HAE Prevention
Astria Therapeutics has initiated the ALPHA-ORBIT Phase 3 trial for navenibart, an investigational monoclonal antibody inhibitor of plasma kallikrein, aiming to treat hereditary angioedema (HAE). This global trial, designed to support registration, is enrolling patients across multiple countries, including the United States, Europe, and beyond.
Navenibart is being developed to prevent HAE attacks, a rare genetic disorder causing swelling in various parts of the body. The ALPHA-ORBIT trial is a pivotal, randomized, double-blind, placebo-controlled study involving 135 adults and 10 adolescents with HAE Type 1 or Type 2. Participants will receive navenibart every 3 months or every 6 months, with the primary endpoint being time-normalized monthly HAE attacks at 6 months.
Astria Therapeutics has received approval from the European Medicines Agency (EMA) to activate 32 sites in 10 EU countries for this trial, with clinical trial sites also open in the United States, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel. The company's mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases, making the ALPHA-ORBIT trial a key milestone in this endeavor.
The ALPHA-ORBIT trial is underway, aiming to demonstrate navenibart's efficacy and safety in preventing HAE attacks. With sites open across multiple countries, Astria Therapeutics is committed to providing rapid and sustained HAE attack prevention, potentially transforming the lives of those affected by this disorder.
