Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi

Sanofi CEO Olivier Brandicourt

Lexicon Pharmaceuticals has posted upbeat data from another phase 3 trial of its Sanofi-partnered dual SGLT1 and SGLT2 inhibitor sotagliflozin. More patients in the treatment arm hit an established target for glycemic control than did in the control cohort, resulting in Lexicon chalking up its third phase 3 success for the diabetes tablet.

The latest trial enrolled 1,402 patients with type 1 diabetes and randomized them to receive either sotagliflozin or placebo. Going into the study the subjects had A1C levels ranging from 7% to 11%. Diabetes associations recommend that patients reduce their A1C levels to below 7%. A1C is a marker that gives an average blood glucose level. The phase 3 trial assessed the proportion of participants in the sotagliflozin and placebo arms whose A1C levels fell to below 7% over 24 weeks of treatment.

Lexicon said the trial linked sotagliflozin to a statistically-significant improvement in the proportion of patients who met the A1C target. The finding adds to evidence that sotagliflozin helps patients with Type 1 diabetes to control their glucose levels.

Exactly how positive the data are is unclear. In the top-line release Lexicon said the trial met its primary endpoint but provided no details about what proportion of patients in each arm saw their A1C levels fall to below 7%. That datapoint will go some way to showing whether sotagliflozin can go beyond beating the placebo and establish itself as an effective treatment for type 1 diabetics.

The FDA and other regulators have already approved inhibitors of SGLT2, one of the targets hit by sotagliflozin, for use in type 2 diabetics. AstraZeneca and Bristol-Myers Squibb’s Farxiga, Boehringer Ingelheim and Eli Lilly’s Jardiance and Johnson & Johnson’s Invokana all compete for this niche.

Lexicon thinks sotagliflozin can improve on these existing therapies by also hitting SGLT1, which mediates the absorption of glucose in the intestines. SGLT2 plays a similar role in the kidneys.

Sanofi identified sotagliflozin as a way to enter and disrupt the nascent market for SGLT2 inhibitors in 2015, prompting it to pay $300 million upfront and up to $1.4 billion in milestones for the global license to the experimental drug. And with sotagliflozin having now come through three phase 3 trials—the first two of which assessed the change in A1C from baseline—it is nearing the day on which it can start recouping some of its outlay.

“We look forward to pursuing regulatory submissions for the treatment of type 1 worldwide,” Sanofi SVP Jorge Insuasty said in a statement.

Sanofi plans to pursue approvals of sotagliflozin in type 1 diabetes while developing the drug for use by people with the type 2 form of the condition. The French Big Pharma is running three phase 3 trials to assess the effect of sotagliflozin on the A1C levels of patients with type 2 diabetes. Sanofi expects to complete the trials in 2018 and 2019.