Furiex Phase II Trial of PPD-10558 Did Not Meet Primary Efficacy Endpoint

Furiex Pharmaceuticals

today announced 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. 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. “We are disappointed with the results, given the promising pre-clinical profile of PPD-10558. We were surprised to see drop-out rates due to muscle symptoms in the placebo treatment group that were comparable to the PPD-10558 and atorvastatin treatment groups,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “We, however, are confident that the study effectively evaluated the clinical hypothesis, and has provided a clear scientific result.”