The thinking behind Lidakol trials

Like many biotech company executives who now realize that getting most products through the FDA won't be a slam dunk, Lidak Pharmaceuticals Inc. chairman and CEO David Katz has been thinking about how to maximize his drug's approvability since the start of clinical trials.

In designing the Phase II trials of the antiviral Lidakol against herpes, Katz said, "we were striving to be sufficiently stringent that in essence we would first find out if we had missed any parameters that we should incorporate." LDAKA chose two primary end points: length of average outbreak and aborted outbreaks, as well as a secondary end point of reduction or cessation of pain.