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Spring Bank Pharmaceuticals Initiates a Phase I Clinical Trial for SB 9200 in HCV-infected Patients
Date:5/23/2013

bination with other classes of HCV antivirals, including direct-acting antiviral agents (DAA) currently in clinical development. In preclinical studies, SB 9200 has shown synergistic antiviral activity when combined with other anti-HCV compounds and has demonstrated an excellent safety profile. In in vitro studies, the compound has demonstrated potent antiviral activity against multiple HCV genotypes 1a, 1b and 3. Thus, this novel mechanism of action is suggestive of pan-genotypic activity and potentially a high barrier to resistance. Moreover, this novel mechanism of action suggests it could have pan-genotypic activity and potentially a high barrier to resistance. These attributes could lead to the use of SB 9200 as part of an Interferon-free, all-oral regimen for HCV therapy.

The Phase I trial is currently being conducted in Australia with plans to expand into clinical sites in New Zealand. The trial is being conducted in two parts. Part A is a single ascending dose of SB 9200 to evaluate the safety and tolerability of a single oral dose of SB 9200, with 8 treatment naive Genotype 1 patients being enrolled into four sequential cohorts of 2 patients each with increasing doses ranging from 100-800mg. Part B of the study is a randomized, double blind, placebo-controlled multiple ascending dose escalation of once daily doses of SB 9200 once a day for 7-14 days. Part B will enroll approximately 40 HCV patients with 5 dosing cohorts, randomized 6:2 active versus placebo. The final dosing cohort will be in Genotype 2/3 patients to demonstrate pan-genotypic activity. The primary endpoint for both parts of the trial is safety. Secondary objectives include an analysis of dose versus viral load reduction, liver function, safety labs, host immune expression, as well as characterization of plasma and urine pharmacokinetics and assessment of pharmacodynamic activity.

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