Updates provided on navenibart (also known as STAR-0215), a potential HAE medicine currently being trialed in patients

A series of updates on navenibart, which is currently undergoing testing amongst HAE patients, were provided by the pharmaceutical company Astria. The key updates shared were:

  • Astria has exclusively licensed development and commercialization rights in Japan to Kaken Pharmaceutical for navenibart.
  • The navenibart Phase 3 program consists of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, which are designed to support registration globally. ALPHA-ORBIT is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of navenibart over a 6-month treatment period, with dosing arms every 3 months (Q3M) and every 6 months (Q6M). Enrollment is ongoing and top-line results are expected in early 2027. After completing ALPHA-ORBIT, eligible patients may continue into the open-label ORBIT-EXPANSE study, which includes 6 months of additional treatment followed by a patient-centric flexible dosing phase.
  • Positive initial results from the ongoing ALPHA-SOLAR long-term open-label trial of navenibart were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. All 16 ALPHA-STAR target enrollment participants continued into ALPHA-SOLAR and the results are highly consistent with ALPHA-STAR – showing robust overall reduction in monthly attack rates (92% mean and 97% median) and a well-tolerated safety profile.

Jill C Milne PhD, Chief Executive Officer at Astria Therapeutics, said: “Delivering on navenibart’s potential is our top priority, and enrollment in the global Phase 3 ALPHA-ORBIT trial is well underway with active sites across the US, UK, Canada, Hong Kong, and South Africa. We are encouraged by the strong enthusiasm from patients and physicians, including at the recent HAEA conference, where we had the opportunity to engage with the HAE community. We were also thrilled to announce a strategic partnership with Kaken. Their expertise supports our ongoing Phase 3 enrollment, and may ultimately help expand global patient access to navenibart.”

(Source: Astria)