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news.Metabasis Therapeutics' partner Valeant Pharmaceuticals has unveiled encouraging experimental results from clinical and preclinical studies of pradefovir in patients infected with hepatitis B virus.
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The clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of pradefovir (formerly called remofovir) in patients chronically infected with hepatitis B virus (HBV).
In the study, pradefovir, a prodrug of PMEA, was rapidly absorbed and rapidly converted into PMEA in a dose-dependent manner. Administration of the drug was associated with clinically and statistically significant reductions in serum HBV DNA, a measure of viral load.
Valeant also unveiled preclinical data comparing liver and kidney distribution of pradefovir and adefovir dipivoxil. Results showed that administration of pradefovir resulted in a three-fold higher radioactivity level in the liver but in only 1/6 of the radioactivity level in the kidneys, compared to the radioactivity levels in those organs after dosing with adefovir dipivoxil.
This liver-targeting may lead to improved efficacy with a reduced potential for renal toxicity as compared to adefovir dipivoxil.