Patient enrollment in clinical trial of lonvo-z (also known as NTLA-2002), a potential HAE medicine, has been completed in nine months

A global trial to assess the effectiveness of Lonvoguran Ziclumeran (lonzo-z) in preventing HAE attacks, has completed the enrollment of patients in nine months.

The study, called HEALO, is a global Phase 3 trial. The first data is expected in 2026, and will be used to support the approval of the medicine in the US. The pharmaceutical company Intellia confirmed that a license application (Biologics License Application or BLA) remains on track to be submitted to the US authorities in the second half of 2026.

John Leonard MD, Intellia President and Chief Executive Officer, said: “Completing HAELO enrollment within nine months since dosing the first patient marks a pivotal moment for the company and reflects the degree of unmet need we are hearing from people living with HAE. We are deeply grateful to the patients, their families and the trial investigators for their enthusiasm and look forward to sharing topline results from the Phase 3 study next year. Our momentum remains strong for a planned BLA submission in 2026 as we seek to make this potentially life-changing therapy available to HAE patients starting in the US.”

Aleena Banerji MD, Professor at Harvard Medical School, Clinical Director of the Allergy and Clinical Immunology Unit at Massachusetts General Hospital, and HAELO principal investigator, said: “Based on results from the Phase 1/2 study, lonvo-z shows great promise to positively transform the HAE treatment paradigm. We look forward to seeing the Phase 3 topline data next year.”

(Source: Intellia)