The purpose of the Phase I trial of PW 4153 is to assess the bioavailability and pharmacokinetic blood levels of Penwest’s formulation of the drug in healthy volunteers.
PW 4153 is an extended release reformulation of a marketed drug that is dosed multiple times a day. The goal of this formulation is to extend the dosing interval of the drug while minimizing the peak-to-trough ratio, which Penwest believes may enhance the efficacy, tolerability and convenience of the drug for Parkinson’s patients.
Jennifer Good, president and CEO of Penwest, said: “We are pleased to have initiated this Phase I trial of PW 4153, a product candidate that leverages Penwest’s strengths in both reformulation and drug development. We expect to have data from this trial to share in the fourth quarter of 2008.”