Lexicon, Sanofi tout positive T1 diabetes data
- Lexicon Pharmaceuticals and partner Sanofi on Friday announced positive results from the Phase 3 Tandem1 trial of sotagliflozin in patients with type 1 diabetes.
- The 200mg dose of the drug showed a 0.43% reduction in A1C levels, a measure of blood sugar, compared with a reduction of 0.08% in patients on placebo after 24 weeks. The 400mg dose provided a 0.49% reduction; both statistically significant.
- Tandem1 was a late-stage trial that included 793 patients in the U.S. and Canada who had type 1 diabetes and used an insulin pump or had multiple injections of insulin daily. There were higher rates of severe hypoglycemia in the placebo group, but lower rates of diabetic ketoacidosis.
Sotagliflozin is a sodium-glucose co-transporter type 1 (SGLT1) and type 2 (SGLT2) inhibitor meant to flush out excess glucose through the urine.
While there are several other SGLT2 inhibitors on the market including Johnson & Johnson's Invokana (canagliflozin), AstraZeneca's Farxiga (dapagliflozin) and Eli Lilly & Co's Jardiance (empagliflozin), none of these products are approved for the treatment of type 1 diabetes.
Lexicon and Sanofi expect to start Phase 3 trials in type 2 diabetes patients by the end of the year. The partners are also conducting two other late-stage trials in type1 diabetes patients.
Jardiance has been able to differentiate itself in this already crowded market when Lilly showed the drug has some cardiovascular protective properties.
Lexicon and Sanofi are hoping that by targeting type 1 patients they will be able to separate themselves from competition.
Once the market leader, Sanofi has been flailing in diabetes as multiple competitors have taken on its blockbuster insulin Lantus. The company has been trying to make up ground in other areas of diabetes by signing licensing deals with smaller companies.
Lexicon and Sanofi teamed up in November 2015 in a $1.7 billion licensing deal, which includes royalties and milestones based on regulatory steps and sales.
- Lexicon Pharmaceuticals Press Release
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