LISBON, Portugal—A cadre of SGLT2 meds may have beaten Sanofi and Lexicon Pharmaceuticals to that fast-growing market, but the partners aim to carve out a place for their experimental drug sotagliflozin in Type 1 diabetes.
Lexicon rolled out details from its pivotal studies this week, including new phase 3 data from the inTandem3 study showing that sotagliflozin not only cut blood glucose levels in Type 1 patients, but helped them lose weight and lower their blood pressure. They also needed to use less insulin—a reduction of 3.9 units per day, compared with a 1.1 reduction in the placebo group.
“You could almost say since the 1920s there hasn’t been much innovation for Type 1 patients in terms of drug therapy,” Stefan Oelrich, global head of Sanofi’s diabetes franchise, said in an interview. "Here we will bring a novel treatment to Type 1 patients to significantly increase their quality of life."
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With sotagliflozin added to insulin, “not only are you going to be able to spare insulin and improve A1c by the additional oral agent," Oelrich said, "but we also have time and range improvement of three to four hours per day, and that’s something unheard of.”
The sotagliflozin studies showed patients extended the time period they spent within their target blood-glucose range every day, particularly at the higher 400 mg dose, as shown by continuous glucose monitoring. At that dose, the length of that period grew by 11.7% compared with placebo, or about 2.8 hours longer on average.
The range of data, presented during a symposium Wednesday at the European Association for the Study of Diabetes meeting, showed patients taking sotagliflozin lost more weight—2.2 kg at the mean—compared with 0.8 kg of weight gain for placebo patients. Systolic blood pressure moderated among patients who came into the study with hypertension.
The inTandem3 study was simultaneously published in The New England Journal of Medicine.
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There are 1.25 million Americans living with Type 1 diabetes, according to JDRF, and incidence is increasing worldwide. Associated healthcare costs in the U.S. amount to $14 billion per year.
The reason a few more hours within the target blood-glucose range can be important is that complications of diabetes arise from the damage high blood glucose can cause. The fewer hours patients spend outside that range—70 mg/dL to 180 mg/dL—the better.
Patient reports collected during the trials showed that the extended time and better range improved their day-to-day lives. “Patients are much more happy with that,” Oelrich said.
SGLT2 meds have quickly carved out a place for themselves in diabetes, and Eli Lilly and Boehringer Ingelheim’s Jardiance helped broaden that niche with a new indication as a cardiovascular risk-fighter, granted by the FDA in December. Some analysts figure that it’s a classwide effect, though that’s not been proven.
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None of these meds is approved for Type 1 patients, however. And sotagliflozin, unlike the drugs in that class now on the market, targets both SGLT1 and SGLT2. Jardiance, Johnson & Johnson’s Invokana, and AstraZeneca’s Farxiga all target SGLT2 only. So does Merck & Co. and Pfizer’s candidate in the class, ertugliflozin, submitted to the FDA and European Medicines Agency for approval in March.
Sanofi said the pair intend to submit sotagliflozin to the FDA for approval in Type 1 diabetics early next year, with a decision expected in early 2019. In Type 2, the partners moved sotagliflozin into phase 3 at the end of last year, and Oelrich said two cardiovascular outcomes trials are in the works.
Sanofi inked its sotagliflozin partnership with Lexicon in November 2015, in a deal worth $300 million up front and up to $1.2 billion in follow-up milestone payments.
Sanofi and Lexicon's SGLT2/SGLT1 drug may not be alone in Type 1, however. AstraZeneca reported some data in Type 1 patients at EASD, too, showing Farxiga lowered blood sugar, helped patients lose weight and cut their daily insulin needs.