Lexicon, Sanofi drug could be first oral for type 1 diabetes
- Lexicon Pharmaceuticals, Inc. and Sanofi SA reported data on Wednesday from a third Phase 3 study for their SGLT1/SGLT2 inhibitor sotagliflozin at the European Association for the Study of Diabetes (EASD) annual meeting in Lisbon.
- Results from the inTandem3 study showed 400 mg of sotagliflozin significantly lowered A1C levels in patients with type 1 diabetes versus placebo, reducing blood sugar by 0.46% on a placebo-adjusted basis.
- Additionally, the drug showed a meaningful ability to reduce body weight and systolic blood pressure compared to placebo, as well as lower the amount of bolus insulin patients required during the 24-week study period.
The inTandem3 results, in conjunction with positive results from two previous Phase 3 studies, set sotagliflozin on a path to be the first oral medication approved to treat the type 1 form of diabetes.
Unlike type 2 diabetes, the type 1 form is an autoimmune disease that occurs when the body stops making insulin. Type 1 usually occurs in children (although it is seen in many adults now as well) and is not caused by diet or lifestyle. Also unlike type 2, insulin is currently the only available treatment for these patients.
"Collectively, today’s positive findings as well as data from our two pivotal trials underline the importance and relevance of the dual SGLT1 and SGLT2 inhibitor mechanism of action in diabetes," said Lexicon President and CEO Lonnel Coats in a statement.
"As we remain committed to advancing the science in diabetes and bringing innovative therapies to patients to help improve outcomes and ease the burden of managing their diabetes, we look forward to Sanofi’s filing for global regulatory approval for type 1 diabetes in the first half of 2018."
Sanofi's diabetes business has been struggling of late, as competition for its blockbuster insulin Lantus enters the market and sales drag. A product like sotagliflozin could help the French pharma become competitive again.
Sanofi entered into the deal with Lexicon in November 2015, paying the smaller company $300 million upfront and agreeing to $1.4 billion in milestones, as well as royalties.
The SGLT2 mechanism is well-known to the diabetes community. The first SGLT2 inhibitor, for the treatment of type 2 diabetes, hit the market several years ago and several competitors have followed since. Eli Lilly & Co.'s Jardiance (empagliflozin) was also recently approved as the first diabetes drug to improve heart benefits.
- Lexicon Pharmaceuticals Press release
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