Astria Therapeutics, Inc. reports financial results for the first quarter ended 31 March 2022 and provides corporate update.

“We are looking forward to advancing STAR-0215 into the clinic this year with the Phase 1a trial, which we plan to initiate shortly after our anticipated mid-year Investigational New Drug filing. We expect initial results by year-end,” says Jill C. Milne, Ph.D., CEO of Astria. “Pharmacokinetic modeling suggests that STAR-0215 could be effective at inhibiting plasma kallikrein and has the potential to prevent HAE attacks with subcutaneous administration with a self-injectable device dosed once every three-months or longer. This model informs our plans for the Phase 1a trial, which aims to evaluate safety, tolerability, demonstrate inhibition of plasma kallikrein activity, and establish the prolonged half-life of STAR-0215.”

STAR-0215 for the Treatment of HAE

  • Lead program STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for HAE with dosing once every three months or longer. The goal for STAR-0215 is to provide the most patient-friendly preventative treatment option for people living with HAE.
  • Targeted plasma kallikrein inhibition can prevent HAE attacks by suppressing the pathway that generates bradykinin and causes excessive swelling.
  • Astria expects to file an Investigational New Drug application for STAR-0215 in the middle of this year and plans to initiate a Phase 1a clinical trial shortly thereafter with initial results anticipated by year-end. The Phase 1a clinical trial is planned to be conducted at a single center with healthy volunteers and evaluate several single ascending dose cohorts with subcutaneous administration. The goals of this initial proof of concept trial are to demonstrate safety and tolerability, establish prolonged half-life of STAR-0215, and to demonstrate inhibition of plasma kallikrein activity. We plan to initiate a multi-center, global Phase 1b/2 trial in patients with HAE in 2023.
  • Astria presented preclinical data demonstrating how STAR-0215 binds to plasma kallikrein at the American Academy of Allergy, Asthma, and Immunology Annual Scientific Meeting in February.
  • At the Fc Receptor and IgG Targeted Therapies Conference in April, Astria presented pharmacokinetic modeling data supporting that STAR-0215 can effectively inhibit plasma kallikrein and prevent HAE attacks with subcutaneous dosing volumes appropriate for a self-injectable device dosed once every three months or longer.
    (Source: Astria)