November 17, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Esperion Therapeutics, Inc. was enjoying a nice collateral boost Monday, after news that Merck and Co., Inc. ’s cholesterol lowering drug Zetia had met its primary endpoints increased buzz around its experimental cholesterol drug ETC-1002, said a Citigroup analyst.
Esperion Therapeutics was up more than 9 percent on the news in afternoon trading Monday.
Merck released the results of the IMPROVE-IT study for Zetia (ezetimibe) today, with data that showed conclusively that the drug lowered the risk of heart attacks and strokes in high-risk heart patients when used with an effective statin.
Yaron Werber, who leads the biotech analysis team at Citigroup, said the study reiterated the theory “the lower the cholesterol the better” and lessens regulatory concerns of the U.S. Food and Drug Administration shifting towards requiring outcomes trials before approval.
“While benefits in IMPROVE-IT were modest, the patients were inherently low-risk, and we still view the results as supportive to this theory,” he said.ETC-1002, Esperion’s lead product candidate, is a once-daily small molecule designed to lower LDL-cholesterol levels and avoid common side effects. It is being developed for patients with hypercholesterolemia.
More specifically, Werber said Citi remained buyers of Esperion, viewing the positive data from the IMPROVE-IT trial to lessen concerns about the regulatory hurdles around ETC-1002.
“We believe this surprise positive trial for MRK’s cholesterol drug Zetia, lowers potential need for clinical outcomes trials for `1002 before approval,” Werber wrote in a note to investors. “This enhances `1002’s value in statin intolerant patients, but also put’s the drug’s dismissed ‘add-on’ to statin program back on the radar.”
In a Phase 2 trial on top of statins, ETC-1002 lowered cholesterol 22 percent compared to the 13 to 18 percent typically seem with Zetia, and ETC-1002’s metabolic and other benefits further differentiates the drug, said Werber.
“We also see this news positive for the statin intolerant program where `1002 and Zetia reduced LDL cholesterol 48 percent,” he wrote. The Phase 2b data for ETC-1002 and statin are expected in March 2015.
