AiCuris Receives Orphan Drug Designation for AIC246

AiCuris has announced that AIC246, the Company’s inhibitor against the human cytomegalovirus HCMV, currently undergoing phase IIb testing, has been granted Orphan Drug designation for the prevention of HCMV disease.

This decision was made by the European Commission following the positive opinion released by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

“We are very pleased to have received Orphan Drug status for AIC246. This decision by the authorities confirms our view that this innovative drug will be of significant benefit to those at risk of developing HCMV disease which is a very serious and life-threatening condition.

The Orphan Drug status will also support AiCuris in the development of AIC246 as it gives easier access to scientific support by the agencies, e.g. by advice during the product development phase” commented AiCuris CEO, Prof. Rübsamen-Schaeff.

“Clinicians and patients need an effective and safe means to treat HCMV with well tolerated drugs. Current treatment options suffer from dose-limiting toxicities and offer very few solutions to advance patient care, leaving these patients with a deteriorating disease condition, in particular after development of drug resistance. We believe that we are developing a therapy that will prove to be both effective and safe and at the same time remains efficacious, if resistance has developed against the marketed drugs”, added AiCuris CSO, Dr. Holger Zimmermann.

“This will provide the patient with a much better treatment outcome.”