Edesa Biotech says WHO, USAN adopt generic name for ARDS drug candidate

Edesa Biotech announced the World Health Organization has adopted the international nonproprietary name "paridiprubart" for the company’s monoclonal antibody candidate, EB05. Paridiprubart is currently being evaluated in an international Phase 3 study in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome, a severe form of respiratory failure. The WHO, under its International Nonproprietary Names Program, provides a globally recognized system for selecting unique names to identify pharmaceutically active substances. A nonproprietary name is also known as a generic name. The generic name for EB05, pronounced "par-i-di-proo-bart" is one of the first group of drugs utilizing the WHO’s new nomenclature system for monoclonal antibodies, which is based on antibody type and mechanism of action. The United States Adopted Name Council has also adopted the same generic name for Edesa’s EB05 monoclonal antibody. Paridiprubart has received Fast Track designation from the U.S. Food and Drug Administration following favorable Phase 2 results, which demonstrated significant evidence of the drug’s ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given paridiprubart plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.