One of the most closely watched drug development stories just got a little more interesting. A study of 1,623 people with coronary heart disease or an equivalent risk found that a new pill from Merck (NYSE:MRK) - which is called anacetrapib - lowered LDL, which is bad choleserol, while also raising HDL, so-called good cholesterol, to impressive levels.
At 24 weeks, the pill decreased LDL by 40 percent and increased HDL by 138 percent in patients already treated with a statin. And there were no significant differences from placebo in the primary safety measures studied, such as blood pressure. The pre-specified adjudicated cardiovascular endpoints were defined as cardiovascular death, myocardial infarction, unstable angina or stroke, occurred in 16 patients treated with anacetrapib, or 2 percent, compared with 21 people on placebo, or 2.6 percent (see the Merck statement and complete study results in The New England Journal of Medicine).
The findings, which were presented this morning at the annual American Heart Association meeting, are significant for several reasons. For Merck, of course, this is a rare bit of good news, given that its cardiovascular franchise has been hurt over the past couple of years by the Vytorin scandal (recent background) and FDA rejection of an earlier cholesterol pill called Cordaptive (see this).
Moreover, the new Merck pill is a CETP-inhibitor, the same type of drug that Pfizer was developing a few years ago before it crashed and burned among data that unexpectedly caused several deaths and cast a pall over the wisdom of plowing valuable research dollars into developing similar drugs (back story). Both Merck and Roche (OTCQX:RHHBY), however, persisted (Roche has not yet released clinical results). The Merck data revealed no changes in levels of the aldosterone hormone, which may have caused problems with Pfizer’s (NYSE:PFE) drug, prompting suggestions CETP-inhibitors may become bigger than statins.
“If what we are seeing now is borne out in larger studies, this could be the next big thing that could benefit hundreds of millions of people,” Christopher Cannon, the lead researcher and a cardiologist at Brigham and Women’s Hospital in Boston, tells Bloomberg News at the AHA meeting. “The bad cholesterol goes down to the level you are born with and good cholesterol gets up to twice what you are born with. This is totally unprecedented territory.”
The key phrase, however, is if the same results are ‘borne out in larger studies.’ As always, enthusiasm must give way to evidence.