SAN DIEGO—At last year’s American Diabetes Association annual meeting, Merck & Co. and Pfizer rolled out positive results from two phase 3 studies they hoped would buoy SGLT2 candidate ertugliflozin once it got to market. And this year, they’re doing it again.
On Saturday, the pair announced that their candidate had significantly cut down levels of A1C—a key measure of blood glucose—when coadministered with Merck DPP-4 giant Januvia (sitagliptin) in the first-line setting and, separately, when added to metformin.
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In the frontline study, dubbed Vertis Sita, patients taking either a 5-mg or 15-mg dose of ertugliflozin, in tandem with Januvia, saw their A1C levels come down by 1.6% and 1.7%, respectively. Patients in the placebo arm, by contrast, saw just a 0.4% decline. Plus, significantly more patients taking the ertugliflozin-Januvia pairing got A1C levels down below 7%, the target the ADA recommends
And in the metformin study, Vertis Met, ertugliflozin plus metformin outperformed a placebo-metformin duo in adults whose diabetes wasn't controlled on metformin alone. Patients receiving 5 mg of the SGLT2 with metformin logged A1C reductions of 0.7%, while those getting a 15-mg dose saw A1C lowered by 0.9%. Those in the metformin-placebo arm, by contrast, didn’t see A1C levels fall at all. And once again, significantly more patients taking the Merck-Pfizer prospect reached the sub-7% A1C goal.
Ertugliflozin also triggered body weight and blood pressure reductions across both studies that were “very similar and consistent” to the way it had performed in other trials, Sam Engel, M.D., Merck Research Laboratories’ associate VP of cardiometabolic and women’s health, said in an interview.
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The data follow up on positive data from last year, when the drug hit blood sugar goals in two other studies. One examined it as a monotherapy against placebo, while one looked at it in combo with Januvia against Januvia alone. Those studies went into the data package the companies submitted to the FDA, which accepted three applications for the med—as a monotherapy and in fixed-dose combos with Januvia and metformin—in March.
“We think ertugliflozin, both as a single component, but, in particular, in combination with sitagliptin, really has quite a compelling efficacy and safety profile,” Engel said.
The new results are good news for Merck and Pfizer, which, if they can nab an FDA green light, will be entering the market years behind three SGLT2 nemeses. Ertugliflozin will be battling Eli Lilly and Boehringer Ingelheim’s Jardiance, which has already produced data showing it can improve cardiovascular outcomes; Johnson & Johnson’s Invokana, whose own CV outcomes results will be revealed on Monday at ADA; and AstraZeneca’s Farxiga.
Ertugliflozin’s makers, though, aren’t worried about the competition. “Obviously, head-to-head data are not available,” Engel pointed out, but “I think in particular being able to provide a single component, as well as two fixed-dose combinations, provides really an array of treatment options for patients and for providers of what we think is a really strong SGLT2.”
Merck and Pfizer are paying close attention to their rivals’ performance in the CV space, though—and hoping they can replicate Jardiance’s success. Last year, they doubled down on their own cardiovascular outcomes study, expanding it from 4,000 patients to 8,000 and adding two secondary endpoints: cardiovascular death and a composite endpoint covering CV death and hospitalization for heart failure.
“I think that speaks to our thinking that there is potential promise for the class,” Engel said.