Preliminary results from a phase 1a clinical trial suggest that STAR-0215, a drug candidate for preventing hereditary angioedema (HAE) attacks, is a long-acting inhibitor of plasma kallikrein and was well tolerated in healthy subjects.

“These results mark a significant milestone for STAR-0215 and Astria. We are excited that STAR-0215 has shown early proof of concept for its target profile: of being a long-acting preventative therapy for HAE, with a best-in-class PK [pharmacokinetics] profile, and dosing once every 3 months or less frequently,” said Jill Milne, PhD, chief executive officer of Astria. “We aim to change the way those affected by HAE live with their disease and see these preliminary results as a critical step bringing us closer to improving patients’ lives. We are looking forward to bringing STAR-0215 to patients in the ALPHA-STAR trial early next year.”

STAR-0215 was well tolerated at all doses studied (100 mg, 300 mg, or 600 mg). The most common treatment-related adverse event reported through 84 days for the 3 cohorts was mild, self-resolving injection site reaction. There was no serious adverse events or treatment discontinuations. Moreover, the investigators did not observe clinically relevant changes in liver enzymes or coagulation parameters.


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Pharmacokinetic and pharmacodynamic data were consistent with clinical benefit up to 3 months (STAR-0215’s estimated half life, up to 110 days) for the 2 higher doses and suggest that dosing STAR-0215 once every 3 months or less frequently could be adequate. A single dose of STAR-0215 allowed for a rapid 40% to 60% reduction in factor XIIa-activated cleaved high molecular weight kininogen for at least 3 months.

“Patients want treatment options that can normalize their lives. I am pleased to see STAR-0215 moving forward in clinical development to patients,” said William Lumry, MD, founder and medical director of the AARA Research Center. “We understand the need from the HAE community for an effective treatment with less burdensome dosing administration and are excited to see that potential in STAR-0215.”

The phase 1a randomized, double-blind, placebo-controlled single ascending dose trial of STAR-0215 enrolled 25 healthy adults who received a single subcutaneous administration of the study drug or placebo. Participants are being followed for 224 days.

Given the positive results, Astria Therapeutics plans to initiate a phase 1b/2 trial in HAE patients, ALPHA-STAR, in the first quarter of 2023.

Reference

Astria Therapeutics announces positive preliminary results from the phase 1a clinical trial Of STAR-0215 in healthy subjects. News release. Astria Therapeutics, Inc; December 15, 2022.