DE MONITOR - Dé Pharming Expert schreef op 17 maart 2022 14:41:
Onlangs nog zeer goed nieuws voor de HAE patiënten:
ASTRIA WILL ADVANCE STAR-0215 TO THE CLINIC THIS YEARIn a corporate update following the financial results for the fourth quarter and full-year ended 31 December 2021, Astria Therapeutics, Inc. CEO Jill C. Milne, Ph.D. says:
“We are excited to advance STAR-0215 to the clinic this year with the planned initiation of our Phase 1a study.
STAR-0215 was created with a clear vision aimed at reducing the treatment burden for HAE patients with dosing once every three months or longer. Our goals for the Phase 1a trial are to evaluate safety and tolerability, demonstrate inhibition of plasma kallikrein activity, and establish the prolonged half-life of STAR-0215. We expect initial results from this trial by the end of this year.”
Astria is on track 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 in 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 a prolonged half-life of STAR-0215, and demonstrate inhibition of plasma kallikrein activity. Astria plans to initiate a Phase 1b/2 trial in patients with HAE in 2023.
(Source: Astria)