In one of the most improbable rivalries in the drug development world, tiny Dutch biotech Dezima today laid claim to a successful Phase IIb study of its CETP cholesterol drug TA-8995, putting it on track to a 2015 launch for a Phase III showdown with two giants in the field, Eli Lilly ($LLY) and Merck ($MRK).
TA-8995 is billed as a much more potent CETP inhibitor than either Lilly (evacetrapib) or Merck (anacetrapib) has. In its release today, the Naarden, Netherlands-based biotech says that its experimental drug delivered "very positive" results as both a monotherapy and in combination with statins in lowering levels of bad LDL cholesterol while boosting HDL. And the company, founded two years ago by Professor John Kastelein from the University of Amsterdam, says it's on its way to proving its "best-in-class" status in a late-stage study.
Jumping from a small mid-stage study focused on biomarkers to a late-stage program that can prove longterm health benefits for patients, however, are two radically different objectives. The company did not immediately respond to a query from FierceBiotech about the cost of a late-stage study or how it intends to pay for it.
Balancing cholesterol has been one of the Holy Grails in drug development in recent years, confounding blockbuster-sized programs at Pfizer (torcetrapib) and Roche (dalcetrapib)--which both failed--and keeping Lilly and Merck engaged in their own long-running Phase III studies. An improved cholesterol profile has been linked with reducing the risk of diabetes as well as cardiovascular disease--but so far CETP inhibitors have proved to be wildly expensive failures, while the two other Big Pharma efforts are considered long shots. In Roche's ($RHHBY) case, the failure of dalcetrapib helped inspire a massive shakeup of its pRED R&D division based in Basel.
There were no data in Dezima's announcement today. That will have to wait for an upcoming publication. But the Phase IIb results do bear out, at least so far, the expectations of a group of loyal backers in Forbion Capital Partners and BioGeneration Ventures, which put up the $13 million A round in early 2013. The Dutch government also provided a loan.
"These results are clearly very exciting. Compared to other CETP inhibitors TA-8995 combines the highest levels of efficacy seen on lipid parameters with a 20-fold lower dose," stated Rob de Ree, CEO of Dezima pharma. "Combined with the excellent safety and favorable pharmacokinetic profile this positions TA-8995 as the best-in-class CETP inhibitor as we move towards Phase III."
- here's the release