Motley Fool Rule Breakers pick InterMune (NASDAQ:ITMN) yesterday got another step closer to starting clinical studies of its potential hepatitis C treatment, ITMN-191, when it announced that European regulators had approved the design of its phase 1b study.
Drugmakers normally don't update investors on every little step in the clinical trial process, but six weeks ago shares of InterMune fell more than 20% after an analyst cried that the drug was taking longer to develop than expected because of safety concerns.
InterMune and partner Roche still expect initial results on ITMN-191's safety and efficacy to come from this study in the first quarter of 2008. Previous guidance was for initial study results in the fourth quarter, but the clinical trial process is inherently unpredictable, so InterMune can be forgiven for this modest delay.
Other drugmakers like ViroPharma (NASDAQ:VPHM) and Novartis (NYSE:NVS) have seen some of their hepatitis C treatments go down in flames in recent months (here and here) due to safety issues. The 14-day duration of the ITMN-191 study won't provide answers to many of the safety questions that could pop up with longer-term dosing, but the study will at least give an initial indication of whether the compound works in suppressing the virus in humans.
With efficacy results less than seven months away, it won't be long before we get a glimpse of whether InterMune can replicate or even surpass the super-efficacy results of Vertex Pharmaceuticals' (NASDAQ:VRTX) Telaprevir. Investors should stay tuned for interesting times ahead for InterMune.
