Astria Anticipates Trial of STAR-0215 in Healthy Volunteers This Year
Astria Therapeutics is gearing up to request permission for clinical testing in the U.S. of STAR-0215, its experimental therapy to prevent swelling attacks in hereditary angioedema (HAE).
The company is expected to submit a formal request — in the form of an investigational new drug application — to the U.S. Food and Drug Administration midway through this year. If the agency approves the application, Astria plans to launch a Phase 1a trial to test STAR-0215 in healthy volunteers.
“We are excited to advance STAR-0215 to the clinic this year with the planned initiation of our Phase 1a study,” Jill C. Milne, PhD, Astria’s CEO, said in a press release.
In HAE, an enzyme called kallikrein is abnormally active, leading to the production of excessive amounts of bradykinin — a pro-inflammatory signaling molecule that triggers swelling. STAR-0215 is an antibody-based medication that is designed to block the activity of kallikrein.
The experimental medicine’s mechanism of action is similar to that of Takhzyro (lanadelumab), an approved HAE treatment marketed by Takeda. Preclinical data suggest that STAR-0215 is more potent and more stable in the bloodstream than Takhzyro, according to Astria.
The planned trial would test several different doses of the therapy, given via a single subcutaneous (under-the-skin) injection, in healthy volunteers.
“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,” Milne said.
A half-life is the time it takes for half of a medication to be eliminated from the body. A prolonged half-life means the medicine is active for a longer period of time which, theoretically, could allow for less frequent dosing.
“STAR-0215 was created with a clear vision aimed at reducing treatment burden for HAE patients with dosing once every three months or longer,” Milne said. Of note, Takhzyro is given via subcutaneous injection, usually once every two weeks.
If it gets the regulatory go-ahead, Astria expects the Phase 1a trial will be completed before the end of the year. If all goes as planned, the company is anticipating to begin testing the therapy in HAE patients in 2023.