The matchstick-size pump, called ITCA 650, is loaded with a year’s supply of the widely used diabetes drug exenatide and implanted in abdominal tissue where it delivers the medicine continuously in minute quantities. That keeps levels of the drug steady in the body and assures that patients will stay on treatment.
In the yearlong study involving 535 patients with Type 2 diabetes, those implanted with the device achieved reductions of 1.5 percentage points in a blood-sugar measure known as HbA1c, compared with 0.8 percentage points for those taking Januvia. Januvia patients took one 100-mg pill a day.
The company said the pump also enabled more patients to achieve HbA1c levels below the recommended 7.0% threshold.
The results build on earlier trials to suggest that the once-a-year treatment could be an important option in the sprawling diabetes market. Two studies presented in June at the American Diabetes Association meeting in Boston showed the pump achieved substantial HbA1c reductions against a placebo. The new study, which hasn’t yet undergone peer review, is the first to pit the pump against a commonly prescribed oral treatment, said Kurt Graves, Intarcia’s chairman, president and chief executive officer. Januvia recorded $6 billion in global sales last year.
In response, Merck said: “We are confident that physicians will continue to choose Januvia, the world’s leading branded oral diabetes medicine, to help a broad range of patients with Type 2 diabetes.”
About 29 million Americans have diabetes; world-wide, estimates are that 387 million have the disease. The vast majority have the Type 2 version, which is commonly associated with being overweight or obese. Fewer than half of American diabetics maintain control of their blood sugar, with a failure to take their medicines being a key reason.
“It’s unbelievable how hard it is to make people stay on a chronic medication, especially when they don’t feel sick,” said Anne Peters, a professor of medicine at the Keck School of Medicine at University of Southern California.
Dr. Peters isn’t involved with Intarcia but has been following the device’s development. “If this helps adherence, and over the long haul I think it will, it’s going to make a big difference,” she said.
Intarcia, which was featured in The Wall Street Journal’s Billion Dollar Startup Club in February, plans to file for regulatory approval of the pump in the first half of next year.
The company said side effects of the device were similar to those seen in previous studies, with the percent of patients who had the device removed because of nausea “in the low single digits.” There were no major cases of hypoglycemia, or low blood sugar, said Mr. Graves.
The study also showed that patients treated via the pump lost an average of about 9 pounds compared with about 3 pounds on Januvia.
The pump isn’t being studied for weight loss yet, but Mr. Graves said it was an “exciting” finding.
The company provided few other details, saying it was planning to submit the trial for publication in a medical journal and presentation at medical meetings.
Mr. Graves said the company decided to disclose “top-line” findings in part because the results triggered a $100 million payment to the company from certain investors who recently committed $300 million, some contingent on this and another milestone.
Aug. 18, 2015 8:00 p.m. ET
Write to Ron Winslow at [email protected]
Source: Wall Street Journal Health