Astria's Navenibart Shows Promising Results in HAE Trials

Astria Therapeutics, Inc., a biopharmaceutical company dedicated to developing therapies for allergic and immunologic diseases, announced that the European Commission (EC) has granted Orphan Medicinal Product Designation (OMPD) to navenibart for the treatment of hereditary angioedema (HAE). Navenibart, a monoclonal antibody that inhibits plasma kallikrein, is designed to offer long-lasting prevention of HAE attacks. Early results from the Phase 1b/2 ALPHA-STAR clinical trial show that navenibart significantly reduces monthly attack rates by 90-96% with just one or two doses over six months, while also demonstrating good safety and tolerability.

Jill C. Milne, Ph.D., CEO of Astria Therapeutics, expressed enthusiasm for the OMPD designation in Europe, noting that it, along with the FDA’s orphan drug status for navenibart in the U.S., highlights the global need for new treatments for HAE. She also emphasized the company's anticipation of advancing navenibart into Phase 3 trials in early 2025, continuing its mission to improve the lives of people with HAE worldwide.

The EC grants OMPD in the EU following a recommendation from the European Medicines Agency (EMA) through its Committee for Orphan Medicinal Products (COMP). This designation offers incentives to drug developers working on treatments for rare, life-threatening conditions that affect no more than 5 in 10,000 people in the EU. Benefits include regulatory and financial support, as well as assistance from the EMA in optimizing clinical development.