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ONCE DAILY DUAL-NUCLEOTIDE COMBINATION OF PSI-938 AND PSI-7977 PROVIDES 94% HCV RNA < LOD AT DAY 14: FIRST PURINE/PYRIMIDINE CLINICAL COMBINATION DATA (THE NUCLEAR STUDY)
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Reported by Jules Levin
EASL March 30-April 3 2011 Berlin
E. Lawitz1, M. Rodriguez-Torres2, J. Denning3, M.T. Cornpropst3, D. Clemons3, L. McNair3, M.M. Berrey3, W.T. Symonds3
1Alamo Medical Research, San Antonio, TX, 2Fundacion de Investigacion de Diego, San Juan, PR, 3Pharmasset, Inc., Princeton, NJ
CONCLUSIONS
PSI-938 and PSI-7977 as monotherapy and in combination were generally safe and well tolerated over 7-14 days.
Significant antiviral activity was observed with rapid apha-phase reductions followed by continued beta-phase reductions until the end of treatment or assay LOD was reached.
Of note, PSI-7977 monotherapy produced HCV RNA reductions over 7 days which were similar to PSI938.
No viral breakthrough was observed during therapy
No significant PK interaction between PSI-738 & PSI-7977 was observed
Data support progression to a Phase 2 combination study including PSI-938 and PSI-7977
BACKGROUND
The purine PSI-352938 (PSI-938) was created to be an optimal partner DAA for the pyrimidine PSI-7977. The nucleotides employ different prodrug cleavage pathways, largely independent phosphorylation pathways, competition with separate endogenous nucleotide pools (purine/pyrimidine) and complementary resistance profiles (Sofia J Med Chem 2010, Lam AAC 2010, Reddy Bio Med Chem Ltr 2010). This study is the first proof of concept for the combination of 2 nucleotides for the treatment of HCV infection.
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