Astria Therapeutics, Inc. reports financial results for the second quarter ended 30 June 2022 and provides a corporate update.

“We are thrilled to announce that we have initiated dosing in our Phase 1a trial of STAR-0215 which will provide data that we believe will validate STAR-0215’s differentiated best-in-class profile, including prolonged half-life,” says Jill C. Milne, Ph.D., CEO of Astria. “This is an important milestone as we evaluate STAR-0215 in humans for the first time, and it advances us one step closer to achieving our goal of bringing patients with HAE a therapy that could reduce their disease and treatment burden. We expect preliminary results from the Phase 1a trial by the end of this year.”

Phase 1a Clinical Trial of STAR-0215

  • The Food and Drug Administration cleared Astria’s Investigational New Drug application for STAR-0215 and the company initiated a Phase 1a clinical trial with preliminary results anticipated by year-end 2022.
  • The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 at a single U.S. center. Approximately 24 healthy subjects are expected to receive a single dose of STAR-0215 or placebo in at least three cohorts of 100 mg, 300 mg, and 600 mg administered subcutaneously.
  • The trial will assess safety and tolerability and aims to establish the prolonged half-life and demonstrate inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism for STAR-0215 as a potential best-in-class treatment for HAE.
  • The company plans to initiate a multi-center, global Phase 1b/2 trial in participants with HAE in 2023.

STAR-0215 Highlights

  • At the Fc Receptor and IgG Targeted Therapies Conference in April, Astria presented pharmacokinetic modeling data supporting the potential that STAR-0215 could 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.
  • Astria presented new preclinical data at the European Academy of Allergy and Clinical Immunology 2022 Hybrid Congress that demonstrate STAR-0215’s rapid and durable inhibition of plasma kallikrein in cynomolgus monkeys, supporting the potential for once every three month or longer dosing in humans. The study demonstrated rapid inhibition of plasma kallikrein after subcutaneous administration. Inhibition of high molecular weight kininogen cleavage was rapid and sustained throughout the entire 84-day dose-free period in the extended portion of the study. These data confirm the long half-life of STAR-0215 and demonstrate prolonged pharmacological activity of STAR-0215 in circulation in cynomolgus monkeys.
    (Source: Astria)