Fresh from its IPO earlier this year, Pharmasset
Pharmasset's lead drug, clevudine, is a once-daily treatment for hepatitis B. This pyrimidine nucleoside analog has already been approved in South Korea, and it's been tested in over 800 patients.
Pharmasset licenses the rights to clevudine from a Korean drugmaker, and the drug hasn't yet been approved in the U.S. or European Union, due to their stricter drug approval guidelines. Pharmasset plans to run the drug through phase 3 testing here in the U.S., comparing it head-to-head with leading treatment Hepsera before filing a marketing application with the FDA and European Medicines Agency
The market opportunity for hepatitis b virus (HBV) compounds is nothing to sneeze at. Indeed, Bristol-Myers Squibb's
The blockbuster opportunity for Pharmasset, though, lies in its race to produce a complimentary small-molecule drug for current hepatitis C standards of care. Multiple drugmakers are striving to find similar treatments, including Rule Breakers picks Vertex Pharmaceuticals
Last week, Pharmasset posted the first efficacy results for its hepatitis C virus (HCV) compound, based on a phase 1 study in 40 patients. The drug, R7128, reduced viral loads by up to a mean of 2.7 log for the HCV genotype 1 sufferers in which it was tested in.
Even better, Pharmasset reported that no patients saw the virus levels in their bodies rebound during the fourteen-day study. That suggests that R7128's efficacy could improve over a longer dosing period.
Based on the strength of the phase 1 data, Pharmasset and partner Roche have already slated another study of R7128, in combination with Roche's Pegasys. Data is expected in the first quarter of next year, and if all goes according to plan, phase 2b testing of R7128 will begin later in 2008.
R7128 is a nucleoside inhibitor, and it's worth pointing out that similar drugs have not been as successful in longer-term testing, even if they showed promising phase 1 data. Pharmasset's HCV program can't expect smooth sailing just yet.
Nonetheless, with multiple antiviral candidates aimed at several disease targets, not to mention its anti-HIV compound in phase 2 testing, Pharmasset looks promising enough to merit a spot on Fools' radar screens.