FDA grants orphan drug designation to Artemisone by Artemis Therapeutics for malaria treatment

Artemisone by Artemis Therapeutics, Inc. (Artemis), a clinical-stage biopharmaceutical company developing new therapies for the treatment of life-threatening infectious diseases, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of malaria.

"We are delighted Artemisone has received orphan drug designation from the FDA for the treatment of malaria," stated Brian M. Culley, Chief Executive Officer of Artemis. "With approximately half of the world’s population at risk, malaria presents an unmet global challenge with enormous economic implications. In recent years, artemisinin-resistant malaria has become increasingly common. Our product candidate, Artemisone, is a potent and fast-acting member of the artemisinin class and we believe it may offer a more attractive safety and efficacy profile compared to currently-available artemisinins. We are excited to be moving Artemisone toward additional clinical trials."

The FDA Orphan Drug designation program provides incentives to sponsors that are developing therapies for rare diseases which affect fewer than 200,000 people in the United States. Artemis is now qualified to receive significant benefits throughout its orphan drug development program including more frequent FDA interactions, protocol assistance, and tax credits for clinical research costs. Also included is a waiver of certain fees and a seven-year term of market exclusivity upon FDA approval of the orphan drug. In 2015, malaria caused 212 million clinical episodes and 429,000 deaths, according to the World Health Organisation.

Artemisone is a unique, synthetic artemisinin derivative with potent anti-viral and anti-parasitic properties. The company currently is evaluating Artemisone for the treatment of p. falciparum malaria and human cytomegalovirus (CMV) infections, including stem cell transplant CMV and congenital CMV. Artemis also plans to evaluate Artemisone for the treatment of additional viral and parasitic diseases.