Phenex Pharmaceuticals AG Initiates Phase I First-in-man Study with its Clinical Development Candidate Px-102
9/19/2011 10:22:48 AM
LUDWIGSHAFEN, Germany--(BUSINESS WIRE)--Phenex Pharmaceuticals AG announced today the start of a first-in-man Phase I study with its clinical drug candidate Px-102, a synthetic non-steroidal FXR agonist. The volunteers of the first dose level received the drug and showed no signs of discomfort or other adverse effects. This Phase I first-in-man study will be escalated from the initial dose over seven dose levels to obtain information about the tolerance and pharmacokinetics of Px-102 in healthy volunteers. Following this first Phase I study Phenex plans to run a multiple ascending dose Phase I study where the same parameters will be observed during several days of multiple administrations. The Phase I studies for Px-102 will be finished by early 2012. If all requirements are met, Phenex then plans to test Px-102 in a Phase II study in patients with Metabolic Syndrome and Non-Alcoholic Fatty Liver Disease (NAFLD) to confirm if the potent therapeutic effects such as lipid lowering, improvement of insulin sensitivity and reduction of markers for liver damage which were observed in several animal studies can be reproduced in human patients.