Sanofi-backed Lexicon up after hitting PhIII Type 1 diabetes target

Lexicon Pharmaceuticals ($LXRX) saw its shares jump by nearly 19% premarket this morning as it posted positive results for the late-stage study of its Sanofi-backed diabetes candidate sotagliflozin.

The oral drug, which is being developed under a major $1 billion deal with Sanofi ($SNY), met its primary endpoint of lowering blood sugar levels in Type 1 diabetes patients.

The med, described by the Texas-based biotech as a next-gen therapy, works as a dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), and showed a statistically significant drop in A1C levels in Type 1 patients, with a “background of optimized insulin” for a 6-week period, after a total 6 months of treatment.

The top-line results from its Phase III showed a mean A1C reduction from baseline of 0.43% on a 200-mg once-daily sotagliflozin dose, and A1C reduction of 0.49% on a 400-mg once-daily sotagliflozin dose.

This beat out placebo after 24 weeks, with patients on the dummy pill seeing a reduction of just 0.08%, according to the biotech’s statement.

This reduction also came without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in Type 1 diabetes, which was seen less frequently in both treatment arms than placebo. There were around 800 patients in the inTandem1 trial.

“We are extremely pleased with these top-line results and the potential long-term benefits that sotagliflozin may bring to people with Type 1 diabetes," said Lexicon President and CEO Lonnel Coats.

"We believe these results provide evidence that sotagliflozin, with its novel dual inhibition of both SGLT-1 and SGLT-2, is particularly well suited to help these individuals achieve better A1C levels without increasing and possibly reducing the risk of severe hypoglycemia."

"The inTandem1 study is part of the largest Phase III program for an oral antidiabetic agent in Type 1 diabetes to date," added Anne Peters, a professor at the Keck School of Medicine of USC, director of the USC Clinical Diabetes Programs and chairman of the Sotagliflozin Type 1 Diabetes Steering Committee. “Sotagliflozin demonstrated compelling, significant and clinically meaningful A1C reduction with no increase in severe hypoglycemia and a slight risk of DKA. If approved, sotagliflozin could represent a significant addition to the current standard of care and potentially allow patients with Type 1 diabetes to better manage their diabetes while on insulin.”

Lexicon’s drug works by interrupting the process by which glucose is shuttled around the body, diverting excess blood sugars out through the urine to improve outcomes for patients with diabetes.

On-the-market treatments like AstraZeneca's ($AZN) Farxiga and Johnson & Johnson's ($JNJ) Invokana do the same job by targeting SGLT2, but sotagliflozin is a dual inhibitor of both SGLT1 and 2, a difference its partner Sanofi has bet a potential $1.7 billion will give the drug a competitive advantage, despite looking to get in on a saturated market.

Lexicon’s shares were up as high as 48% premarket before leveling out at around 18% just before normal trading began. It has a market cap of $1.6 billion.