Descriptions of MK-7009 Phase-2a and Phase-2b Trials
The phase-2a trial started in Aug 2008, enrolled 85 patients, and is expected to finish in May 2010. It includes 4 weeks of MK-7009 added to SoC followed by SoC alone for 44 weeks (48 weeks in all). One arm has MK-7009 dosed at 800mg qD; however, this dose was not carried forward to phase-2b and hence MRK is committed to BID dosing, which is not considered a problem in an HCV regimen where ribavirin (a BID drug) is part of the cocktail.
The phase-2b trial is planned to start in Apr 2009, will enroll 200 patients, and is expected to finish in Jul 2011. It will include both 24- and 48- week arms with MK-7009 added to SoC. The 24-week arms will test 600mg BID while the 48-week arms will test both 300mg BID and 600mg BID. The 24-week arms consist of one arm stopping all treatment after 24 weeks (as in the Telaprevir trials) and one arm that continues SoC alone for an additional 24 weeks (48 weeks in all). Interestingly, this trial does not employ a 4-week lead-in period on SoC only as VRTX and SGP have done with Telaprevir and Boceprevir.
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