Astria Therapeutics has commenced the Phase Ia clinical trial of monoclonal antibody inhibitor of plasma kallikrein, STAR-0215, to treat hereditary angioedema (HAE).
The randomised, placebo-controlled, double-blind single ascending dose trial has been designed to assess STAR-0215’s pharmacokinetics, pharmacodynamics, and safety in healthy subjects.
To be conducted at a single centre in the US, the Phase Ia trial will establish clinical proof of concept for the differentiated profile expected for STAR-0215.
In the study, around 24 participants will be given a single STAR-0215 dose or placebo in at least three cohorts of 100mg, 300mg, and 600mg subcutaneously.
It will evaluate the safety and tolerability and has a goal to establish a prolonged half-life and demonstrate inhibition of plasma kallikrein activity.
It will also provide proof of mechanism for STAR-0215 as a potential HAE treatment.
Preliminary results from the Phase Ia trial are expected by the end of the year.
Astria Therapeutics chief medical officer Chris Morabito said: “The initiation of the Phase 1a trial of STAR-0215 in healthy subjects is an important milestone for us, as it marks our progression to a clinical-stage company and is a critical next step towards our goal of improving the disease burden for people living with HAE.
“We are proud of our progress so far, and the initiation of our first clinical trial in HAE is a representation of our commitment to bringing hope with life-changing therapies to patients affected by rare diseases.”
STAR-0215 has been designed for providing long-acting, effective attack prevention for HAE.
It demonstrated to be a potent, long-acting, and selective inhibitor of plasma kallikrein, according to preclinical data.