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news.Astria Therapeutics received the European Commission's orphan medicinal product designation (OMPD) for navenibart (STAR-0215) to treat hereditary angioedema (HAE).
The clinical trial has shown positive results, with the antibody demonstrating a favourable safety and tolerability profile. Credit: National Cancer Institute on Unsplash.
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This designation is a significant milestone for the monoclonal antibody plasma kallikrein inhibitor, which is designed to provide long-acting prevention of HAE attacks.
Navenibart is effective even without the presence of C1 inhibitor, offering a new hope for individuals living with this rare condition.
The OMPD in the European Union (EU) is a status conferred by the EC upon the recommendation of the European Medicines Agency (EMA) and its Committee for Orphan Medicinal Products (COMP).
The Phase Ib/II ALPHA-STAR trial has shown positive results, with navenibart demonstrating a favourable safety and tolerability profile.
Participants experienced a substantial reduction in mean monthly attack rates, ranging from 90 to 96%, for up to six months. These findings also support the feasibility of dosing every three to six months.
Astria Therapeutics CEO Jill Milne said: “We are very pleased to receive orphan medicinal product designation for navenibart in Europe.
“We believe that OMPD status, in combination with the FDA’s designation of navenibart as an orphan drug in the US, reinforces both the global unmet need for people with HAE and the potential for navenibart to change the way that people live with HAE.
“We look forward to the expected progression of navenibart into a Phase III trial in the first quarter of 2025 and continuing our efforts to bring a new treatment option to people living with HAE around the world.”
In August 2024, Astria Therapeutics selected YpsoMate as the injection device for navenibart.
The initiation of the Phase III trial for navenibart is expected in the first quarter of 2025, with top-line results anticipated by the end of 2026.
The designation follows the US Food and Drug Administration’s (FDA) orphan drug and fast track designations.
