Caprion’s E. coli treatment gets regulatory backing

The investigational therapeutic monoclonal antibodies, caStx1 and caStx2, have been granted orphan drug status for the treatment of Shiga-toxin producing E. Coli (STEC) infections. This designation provides Caprion with, among other benefits, ten years of potential market exclusivity if the product is approved for marketing in Europe and seven years exclusivity if approved in the US.

“These key designations in two critical jurisdictions reinforce our belief that our drug has the potential to become the first viable treatment for this devastating disease,” said Marc Riviere, executive vice-president of clinical development at Caprion.

STEC is a life-threatening condition that affects approximately 97,000 persons annually in Europe and more than 100,000 people per year in the US according to the Centers for Disease Control. There is no known treatment for STEC infections. Caprion is developing its product to neutralize the circulating toxins in the body in order to treat the disease and prevent its major complications.

European and US regulations on orphan medicinal products are designed to encourage companies to develop and market treatments for rare medical conditions. Orphan drug status provides regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and protocol assistance for clinical development.