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news.Pharmasset, a clinical-stage pharmaceutical company committed to discovering, developing, and commercialising novel drugs to treat viral infections, has initiated dosing in a Phase 1 single ascending dose (SAD) study in healthy volunteers with PSI-938, a purine nucleotide analog polymerase inhibitor of hepatitis C virus (HCV).
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Pharmasset has recently filed an Investigational New Drug Application (IND) with the FDA.
Pharmasset said that Purine nucleoside/tide analogs have many of the benefits of pyrimidine nucleoside/tide analogs, such as RG7128 and PSI-7977, in that they have demonstrated in-vitro activity across multiple HCV genotypes, have a higher barrier to resistance than other classes of HCV small molecules in development, and have a lower risk of drug interactions when combined with other direct acting antivirals targeting HCV.
In addition, Pharmasset’s purine analogs retain activity against the S282T mutation associated with in vitro resistance in other nucleoside/tide analogs in development, and are metabolized to the active triphosphate form through a different phosphorylation pathway than the pyrimidine analogs.
Michelle Berrey, chief medical officer at Pharmasset, said: “PSI-938 is our first purine nucleotide analog to move into clinical development. As PSI-938’s resistance profile is different from other nucleoside/tides in development for HCV and it has a different metabolic pathway from pyrimidine analogs, such as RG7128 and PSI-7977, we believe PSI-938 could be potentially combined with other nucleosides in development to deliver a pan-genotype regimen. We look forward to reporting the first antiviral data with PSI-938 in the third quarter of 2010.”