SGP disclosed this drug for the first time on its R&D webcast in November. The phase-1b efficacy results are shown below. Two arms are treatment-naïve and two are treatment-experienced, two are BID with ritonavir boosting, and two are TID without ritonavir. (Only BID and qD dosing are tested in phase-2b—see below.)
The phase-2a trial started in Nov 2008, will enroll 140 patients, and is expected to finish in Jan 2011. The maximum exposure to SCH 900518 is 12 weeks, and the total duration of treatment is 24 or 48 weeks depending on RVR. The following doses of SCH 900518 are tested: 200, 400, and 600mg qD; and 100mg BID. Each dose of SCH 900518 is boosted by 100mg of ritonavir.
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