Astria Therapeutics reports second quarter 2024 financial results and provides a corporate update

Astra Therapeutics reported financial results for the second quarter ended 30 June 2024, and provided a corporate update.

Jill C. Milne, PhD, Chief Executive Officer at Astria Therapeutics, said: “As we prepare for Phase 3 with initiation expected in Q1 2025, our vision for navenibart is to be the market-leading treatment for HAE, a large and growing market.”

Navenibart (STAR-0215)

  • The World Health Organization’s (WHO) International Nonproprietary Names (INN) Expert Committee and the United States Adopted Names (USAN) Council of the American Medical Association (AMA) have adopted navenibart (nah-VEN-eh-bart) as the nonproprietary name for STAR-0215. Based on the WHO monoclonal antibody (mAb) nomenclature scheme which took effect in November 2021, the infix “-eni-” represents enzyme inhibitor and the suffix “-bart” represents a monoclonal antibody. The prefix “nav” represents Astria’s commitment to navigate the development navenibart with patients guiding the journey.
  • In March, the Company shared positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 trial of navenibart in people with hereditary angioedema (HAE). Navenibart administered once or twice over six months reduced monthly attack rates by 90-96% and supports chronic dosing two or four times per year. Additionally, navenibart was well-tolerated with no serious adverse events and no discontinuations. The Company plans to report additional data from ALPHA-STAR in Q4 of 2024.
  • All of the original 16 target enrollment patients from ALPHA-STAR have entered or consented to enter the ALPHA-SOLAR long-term open-label trial. Initial safety and efficacy data from ALPHA-SOLAR, including from Q3M and Q6M administration, are expected mid-2025.
  • Based on the positive results from the ALPHA-STAR trial, Astria plans to advance navenibart to Phase 3 development. Pending regulatory feedback, the Company plans to initiate the Phase 3 program in Q1 2025 and expects top-line results by year-end 2026. The goal is to enable patients to choose what works best for them by developing both Q3M and Q6M dosing options. The company believes navenibart will be life-changing for HAE patients and has the opportunity to become the market leading HAE treatment.
  • In a separate press release, the company recently announced that it has chosen Ypsomed as its partner for the development of an autoinjector for navenibart.

(Source: Astria)