Astria Therapeutics has initiated a Phase 3 clinical trial to study its experimental therapy navenibart in adults and adolescents with hereditary angioedema (HAE). The study, called ALPHA-ORBIT (NCT06842823), is planned to be pivotal, meaning, if the results are positive, the trial may serve as the basis to…

The first patient has been dosed in a Phase 3 clinical trial testing NTLA-2002, Intellia Therapeutics’ gene-editing treatment candidate for hereditary angioedema (HAE). The trial, called HAELO (NCT06634420), is expected to enroll an estimated 60 adults with HAE types 1 or 2; it’s recruiting participants at five…

Astria Therapeutics is on track to start a Phase 3 clinical trial of navenibart, its therapy to prevent swelling attacks in people with hereditary angioedema (HAE), by March. The trial, dubbed ALPHA-ORBIT, will test flexible dosing schedules, with navenibart being given every three months and every six months.

Astria Therapeutics is planning the launch of a Phase 3 clinical trial in early 2025 to test different dosing schedules of navenibart, its preventive therapy for hereditary angioedema (HAE). The goal, according to Astria, is to provide flexibility for patients, with different dosing options, should the treatment candidate…

Intellia Therapeutics has launched a Phase 3 clinical trial to evaluate the efficacy and safety of NTLA-2002, a single-dose gene-editing therapy for people with hereditary angioedema (HAE). The new trial, dubbed HAELO (NCT06634420), was given the green light by the U.S. Food and Drug Administration (FDA) based…

Pharvaris said it plans to initiate a Phase 3 clinical trial by the end of the year to test an oral, extended-release tablet formulation of deucrictibant as a preventive, or prophylactic, treatment for hereditary angioedema (HAE). Called CHAPTER-3, the trial will assess the treatment’s safety and efficacy…

Regulatory authorities in Japan, the U.S., and the European Union have aligned on plans for a Phase 3 clinical trial to test the oral medication deucrictibant as a prophylactic (preventive) treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE). With alignment from the U.S.

The investigational therapy donidalorsen was well tolerated and significantly reduced the rate of swelling attacks in hereditary angioedema (HAE) patients, meeting the main goal of the Phase 3 OASIS-HAE trial. Other secondary trial goals were also met, according to Ionis Pharmaceuticals, which is developing the treatment. The company…

The Phase 3 KONFIDENT trial, which is testing oral sebetralstat as an on-demand treatment for hereditary angioedema (HAE), has achieved its targeted number of on-treatment swelling attacks. The trial can wrap up now that three attacks per patient were treated. Topline data is expected in early 2024. If…

Pharvaris is now gearing up startup activities with clinical site investigators and staff to launch a Phase 3 trial next year of PHVS416 — an immediate-release capsule formulation of deucrictibant — as an on-demand treatment for hereditary angioedema (HAE). The Switzerland-based clinical-stage company recently met with the U.S. Food…