European HAE patients are now being sought for a trial of a potential HAE medicine

Clinical trial sites in the European Union (EU) have now opened to begin screening participants for the Phase 3 ALPHA-ORBIT trial of navenibart, a potential treatment of hereditary angioedema (HAE) with the potential for dosing every three and six months.

The trial, being conducted by the pharmaceutical company Astria, is enrolling through clinical trial sites across the United States, Europe, the United Kingdom, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel. Approval for the ALPHA-ORBIT trial from the European Medicines Agency (EMA) means an anticipated 32 sites in 10 EU countries: Bulgaria, the Czech Republic, France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal, and Spain.

Christopher Morabito, MD, Chief Medical Officer at Astria Therapeutics, said: “We’re thrilled to be enrolling eligible participants in the EU for the Phase 3 ALPHA-ORBIT trial. The excitement we’re seeing from physicians and patients in the EU underscores navenibart’s potential to change the way people live with HAE across the globe.”

Danny Cohn, MD, PhD, Head of the HAE Center of Expertise at Amsterdam UMC, Amsterdam, the Netherlands, said: “Navenibart’s profile is compelling for people living with HAE, and we are thrilled that HAE patients in Europe now have the opportunity to enroll in the ALPHA-ORBIT trial. We encourage patients to work with their physician to learn more about the ALPHA-ORBIT trial and navenibart.”

Maria Kortekaas, President of HAE Netherlands, an HAEi member organization, said: “People living with HAE are waiting; not just for treatments that reduce the burden of disease, but for those that also ease the burden of treatment. Clinical trials are part of the promise of progress, and we are pleased that Astria has chosen to conduct this late-stage trial in numerous countries throughout Europe.”

(Source: Astria)