A potential Lipitor generic competitor has failed in phase 2 clinical trials, Furiex Pharmaceuticals announced this week.
“Given the results of this recent phase 2 clinical trial, Furiex will not move forward with PPD-10558,” Morrisville, N.C.-based Furiex Chairman Fred Eshelman said in a statement. “We will continue to advance our other clinical programs and remain committed to our product portfolio and pipeline to support and create value for the company.”
The PPD-10558 compound had been studied in patients with the muscle pain known as statin-associated myalgia (SAM), one of the side effects of statins that can limit ability to tolerate the drugs. Furiex told MedCityNews that PPD-10558 targeted delivery of the drug to the liver, cutting down on muscle-related side effects.
But Furiex told the site the compound did not meet the goal of showing efficacy in the latest phase 2 clinical trial results, when compared to a placebo and Pfizer's Lipitor, which has dominated the statin drug market and whose patents have now expired. Patient drop-out rates in the placebo group due to muscle symptoms were the same as the PPD-10558 and Lipitor treatment groups, Furiex Chief Medical Officer June Almenoff said in a statement.
Furiex licensed PPD-10558 from Ranbaxy Laboratories to treat high blood cholesterol levels in 2007, while it was part of Wilmington, N.C.-based clinical research organization PPD.
