“We are on track to report preliminary results from our Phase 1a trial of STAR-0215 by the end of this year. The trial is assessing safety and tolerability and will inform on dosing frequency and target engagement. We believe the results from this trial will validate STAR-0215’s differentiated best-in-class profile,” says Jill C. Milne, Ph.D., CEO of Astria Therapeutics, Inc., at the presentation of the financial results for the third quarter ended 30 September 2022: “STAR-0215 is a long-acting monoclonal antibody inhibitor of plasma kallikrein that has the potential to reduce treatment burden for patients with HAE with dosing once every three months or longer.”

Phase 1a Clinical Trial of STAR-0215

  • The Food and Drug Administration cleared Astria’s Investigational New Drug application for STAR-0215 in July 2022.
  • The Phase 1a randomized, double-blind, placebo-controlled single ascending dose trial evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 at a single U.S. center was initiated in August 2022. Astria has enrolled and dosed 24 evaluable subjects who were randomized to receive single subcutaneous administrations of one of three dose levels of 100 mg, 300 mg, or 600 mg of STAR-0215 or placebo. The subjects are now in the follow-up phase.
  • The trial 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, single and multiple dose Phase 1b/2 proof-of-concept trial in people living with HAE, called ALPHA-STAR, or Astria Long-Acting Prophylaxis for HAE: STAR-0215, in Q1 2023, subject to favorable Phase 1a results.

STAR-0215 Highlights

  • 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)