News

Phase 1b/2 trial of STAR-0215 is now enrolling HAE patients

Astria Therapeutics has initiated a Phase 1b/2 trial called ALPHA-STAR to test STAR-0215, the company’s investigational therapy to prevent swelling attacks in people with hereditary angioedema (HAE). ALPHA-STAR (NCT05695248) intends to enroll 18 adults with HAE types 1 or 2 who have had at least four swelling…

Woman with HAE, normal C1-INH has attacks despite preventive care

Despite long-term preventive treatment, a 38-year-old woman with hereditary angioedema (HAE) with normal C1-inhibitor levels had severe episodes of disease worsening, as described in a recent case report. The life-threatening sequelae and decreased quality of life illustrate the need for more research with this rare form of HAE, according…

BioCryst, Swixx BioPharma Partner on Orladeyo in Europe

BioCryst Pharmaceuticals has tapped Swixx BioPharma to commercialize the hereditary angioedema (HAE) treatment Orladeyo (berotralstat) in central and Eastern Europe. Agreement terms call for Swixx, a Switzerland-based biopharmaceutical company, to handle commercialization of the oral therapy in 15 markets. “We continue to build partnerships with companies…

APeX-P Trial of Orladeyo Now Enrolling Children 2–11 With HAE

Enrollment has begun in APeX-P, a Phase 3 trial designed to evaluate the effects of Orladeyo (berotralstat) in up to 20 children, ages 2–11, with hereditary angioedema (HAE). The open-label study, sponsored by BioCryst Pharmaceuticals, will provide data on Orladeyo’s safety, pharmacological properties, and ability to prevent…

HAE Therapy ADX-324 Enters Phase 1 Clinical Testing

The first group of participants has been dosed in a Phase 1 clinical trial evaluating the safety and pharmacological properties of ADX-324, an experimental treatment for hereditary angioedema (HAE) that is being developed by Adarx Pharmaceuticals. “Dosing of our first participants in this trial is a major milestone…

Bowel Surgery Necessary for HAE Patient After Therapy Fails

Despite being treated for gastrointestinal symptoms of a hereditary angioedema (HAE) attack, an 80-year-old woman with the disease had to undergo surgery to pinpoint their exact cause. Her abdominal pain, vomiting, and nausea eased only mildly with a C1-esterase inhibitor (C1-INH) concentrate, a type of medication usually recommended to…

UK Gives Regulatory Support to NTLA-2002 as Patient Trial Advances

NTLA-2002, an experimental gene-editing therapy for hereditary angioedema (HAE) being developed by Intellia Therapeutics, has been awarded an innovation passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the company announced. This designation is the first step in the U.K.’s Innovative Licensing and Access…