An investigational statin drug being developed by Furiex Pharmaceuticals (NASDAQ:FURX) has failed in phase 2 clinical trials, ending an attempt to produce what the company hoped would become an alternative to blockbuster Pfizer (NYSE:PFE) drug Lipitor.
The compound PPD-10558 was being studied in patients with statin-associated myalgia, or SAM. This muscle pain can be one of the side effects for patients on statins and can limit patients’ abilities to tolerate the drugs. Morrisville, North Carolina-based Furiex had said that PPD-10558 offered targeted delivery to the liver, minimizing muscle-related side effects.
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But in the latest phase 2 clinical trial results, Furiex said the compound did not meet the primary trial endpoint of showing efficacy. The drug was compared against both a placebo and Lipitor, the blockbuster Pfizer drug that has dominated the statin drug market, but whose patents have expired. In a statement, Furiex Chief Medical Officer June Almenoff said that patient drop-out rates due to muscle symptoms in the placebo group were comparable to the PPD-10558 and Lipitor treatment groups.
“Given the results of this recent phase 2 clinical trial, Furiex will not move forward with PPD-10558,” 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.”
Furiex licensed PPD-10558 in early 2007 from Ranbaxy Laboratories to develop, manufacture and market the Ranbaxy compound as a treatment for high blood cholesterol levels. Furiex will owe a $1 million milestone payment to Ranbaxy upon completion of the final report for the phase 2 study.
The Ranbaxy deal for PPD-10558 was done while Furiex was part of Wilmington, North Carolina clinical research organization PPD. The CRO spun off the drug development unit as a separate, public company last year.
