Furiex's phase II PPD-10558 trial does not meet primary efficacy endpoint
Furiex Pharmaceuticals has reported top-line results from the phase II trial of the investigational drug PPD-10558 in patients with statin-associated myalgia, or SAM. PPD-10558 did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study. The study enrolled patients with high cholesterol and a prior history of SAM, and evaluated recurrence rates for SAM over a twelve-week treatment period across the following three different treatment regimens: placebo; PPD-10558; and atorvastatin (Lipitor). Patients did not report any significant differences in muscle symptoms, nor did they drop out due to SAM in significantly different percentages, among the three regimens. As expected, however, PPD-10558, a novel statin, did significantly lower LDL-cholesterol compared with placebo, and the compound also had a favorable safety profile.
Furiex acquired an exclusive license rights in 2007 from Ranbaxy Laboratories to develop, manufacture and market its novel statin PPD-10558 for the treatment of dyslipidemia. Furiex will owe a $1.0 million milestone payment to Ranbaxy upon completion of the final report for the phase II study.