Fodosine, which is being studied in a phase IIa clinical trial, is a transition state analog inhibitor which binds to the target enzyme.
The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and speed up the review of new drugs that are intended to treat serious or life-threatening conditions.
“This decision of the FDA underpins our confidence in Fodosine as an effective therapy for the treatment of T-cell leukemia,” said Charles Bugg, CEO of BioCryst. “The next step is to take Fodosine into a pivotal study where we will test its ability to halt disease progression in patients who have failed standard treatment regimens.”