According to Fierce Biotech, Merck greatly impressed an audience at the American Heart Association meetings with "jaw-dropping" data on its new CETP inhibitor, anacetrapib. Remarkably, in a small clinical trial, the drug increased the "good cholesterol" HDL by 140% and decreased the "bad cholesterol" LDL by 40 percent. The study's lead investigator indicated the results were wildly unexpected in both directions.
Analysts think Merck may have a mega-blockbuster on its hands with this brand new class of drug - some have predicted that anacetrapib could rack up numbers like Pfizer's Lipitor someday. Merck is anxiously trying to avoid the catastrophic failure Pfizer experienced with torcetrapib, another CETP inhibitor. Four years ago Pfizer had to halt its pivotal study after finding that the drug arm was experiencing a higher death rate. Merck designed this initial smaller trial to look at both the therapeutic effects and at patient safety as a result. In this trial, no significant adverse effects were noted. Now Merck will move on to another larger trial.
In a related post in the Forbes blog, Harlan Krumholz lauds Merck for "doing the right thing" with its trial design - given Pfizer's safety disaster with torcetrapib in late stage clinicals. Torcetrapib was anticipated to be a sure blockbuster but was found to increase deaths and heart disease events in a large clinical trial. The results surprised most observers as the drug seemed sure to be a great success.
This Merck's DEFINE study, presented to a plenary session at the meeting, confirmed the drug’s powerful effect on laboratory values. It also showed that the drug did not have a major harm or benefit – though it was too small to detect modest harms or benefits. Nevertheless, the drug has passed an important test with this trial – and Merck is now proceeding with the next step, a large clinical trial. Merck did the right thing in looking at the safety aspects too in this early stage with an appropriately designed study. Anacetrapib will not reach the market until at least 2015, but it has passed the latest step in a way that takes patient safety in mind, as well as clinical results.
Posted by Bruce Lehr November 18th 2010.