ViroPharma: Aiming narrowly, thinking bigger

In its ongoing Phase III trials of pleconaril to treat viral respiratory infections caused by picornavirus, ViroPharma Inc. is using prior experience with the compound to refine patient inclusion criteria to enhance the likelihood of statistical significance. Because there are no other treatments for such infections, and because there is no diagnostic for picornavirus, VPHM is not worried that strict inclusion criteria will lead to a narrow label.

Pleconaril, a small molecule which binds to picornavirus coat proteins to prevent uncoating and infection, is in two 1,000-patient Phase III trials in adults and adolescents with viral respiratory infections (VRIs). Data from the studies are expected in the second quarter of 2001, with an NDA targeted for mid-year...