Astria Therapeutics is advancing its preventive therapy, navenibart, for hereditary angioedema (HAE) with a planned Phase 3 clinical trial slated to begin in early 2025. The trial will assess various dosing schedules of the subcutaneous injection to provide patients with flexible treatment options, pending regulatory approval. This development follows promising results from earlier trials, positioning navenibart as a potential market leader in HAE treatment.
Upcoming Phase 3 Trial Design
The Phase 3 trial design is being finalized in consultation with regulatory agencies, with expectations that results will be available by the end of 2026. Navenibart (formerly known as STAR-0215) is designed for subcutaneous administration, with plans to evaluate dosing regimens of every three and every six months. The trial aims to confirm the efficacy and safety profile observed in earlier studies.
Mechanism of Action and Clinical Data
HAE is characterized by swelling attacks resulting from excessive bradykinin production. Navenibart works by inhibiting kallikrein, the enzyme responsible for bradykinin production, thereby reducing the risk of swelling attacks. Interim data from the Phase 1b/2 ALPHA-STAR trial (NCT05695248) demonstrated a greater than 90% reduction in swelling attacks with infrequent dosing (once or twice over six months), and no serious safety concerns were reported.
Jill C. Milne, PhD, Astria’s CEO, stated, "We are excited about the opportunity for navenibart to be the market-leading therapy for HAE. We expect that navenibart’s profile, including infrequent dosing, low risk of pain, and trusted mechanism and modality, will give both patients and physicians confidence when choosing a medicine for HAE."
Ongoing Studies and Regulatory Designations
All participants who completed the ALPHA-STAR trial have enrolled in the ALPHA-SOLAR extension study (NCT06007677), receiving either 300 mg of navenibart every three months or 600 mg every six months. Astria anticipates reporting final data from ALPHA-STAR by the end of 2024 and initial data from ALPHA-SOLAR in mid-2025.
Navenibart has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and orphan medicinal product designation by European regulatory authorities. These designations provide economic incentives, including market exclusivity, to encourage the development of treatments for rare diseases like HAE.
