ViroPharma: Try, try again
Despite missing the primary end point in its first three true Phase III studies of pleconaril in two different viral indications, ViroPharma Inc. believes it has learned enough about conducting clinical trials with the small molecule to demonstrate a significant treatment effect in subsequent Phase III studies.
The company's plans to focus on patient subgroups most likely to benefit from treatment is a strategy with historically mixed results. But in a situation analogous to recently approved treatments for influenza infection, VPHM may need to show only an incremental benefit in picornavirus-infected patients to gain approval.
Pleconaril binds to the VP1 picornavirus capsid protein, inhibiting viral binding to cell surface receptors as well as preventing uncoating and release