Island Pharmaceuticals Ltd. (ILA.AX), an antiviral drug development and biodefence company, on Wednesday announced receipt of an orphan drug designation for Galidesivir in the post-exposure prophylaxis of Marburg virus disease from the U.S. Food and Drug Administration (FDA).
The Marburg virus can be transmitted from contact with the Rousettus fruit bat, or other infected individuals. The virus has caused sporadic outbreaks over the years in Germany, Serbia, Uganda, Ghana, Kenya, Rwanda and most recently in Tanzania. While mortality rates can reach 88% without proper care, the average fatality rate is 50%. There are no approved vaccines or antiviral therapies developed exclusively for Marburg virus disease.
Galidesivir is an antiviral agent originally developed by BioCryst Pharmaceuticals for the treatment of Hepatitis C and is currently being explored for the treatment of Ebola and Marburg viruses.
The company previously reported the execution of a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to acquire the required non-human primates to carry out the optimization study for galidesivir. Additionally, the company has initiated a GMP review for its manufacturing studies and pivotal studies to potentially accelerate approval under the FDA Animal Rule pathway.
ILA.AX is currently trading on the Australian Securities Exchange at AU$0.37, up 4.23%.
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