Merck ($MRK) says that a once-weekly diabetes drug in its pipeline significantly reduced blood sugar in a Phase IIb trial, setting the stage for a big late-stage effort to push the therapy through to an approval.
The drug is a DPP-4 inhibitor dubbed MK-3102, a little known program that came to light a few months ago after a Chinese investigator was convicted of stealing a few grams of the drug and selling it on the Internet for a few thousand dollars.
But it's worth considerably more than that to Merck, which sees MK-3102 as a new compound that could offer an improvement on Januvia, its $6 billion daily diabetes treatment. "We do anticipate the efficacy, safety and tolerability of this will be comparable to sitagliptin," Nancy Thornberry, the franchise head for diabetes and endocrinology at Merck Research Laboratories, told Reuters.
After 12 weeks of treatment "the placebo-adjusted reduction from baseline in HbA1c was 0.71 percent with MK-3102 25 mg; 0.67 percent with 10 mg; 0.49 percent with 3 mg; 0.50 percent with 1 mg; and 0.28 percent with 0.25 mg. A statistically significant trend was observed across doses studied for the secondary endpoints of 2-hour post-meal glucose and fasting blood glucose."
"Since the discovery of the DPP-4 inhibitor class, Merck has been actively committed to advancing the science of how to treat type 2 diabetes. We are encouraged by these Phase IIb results in patients with type 2 diabetes, and we are initiating Phase III studies to move MK-3102 forward in the development process," Thornberry said in a statement.
Working in a familiar field may give Merck an advantage in Phase III, but the FDA has set a high standard on safety for any new diabetes therapy. Investigators will be expected to produce a solid set of long-term safety data before this drug makes it to the market.
- here's the press release
- here's the Reuters story