Lexicon 3-for-3 in PhIII for a new diabetes pill, racking up a clean sweep under $1.7B Sanofi pact

Lexicon Pharmaceuticals $LXRX is now three-for-three in its Phase III program for sotagliflozin, setting up regulatory applications for this Sanofi-partnered therapy as the first pill to help Type 1 diabetics with glycemic control. And it positions the Texas biotech for its late-stage effort aimed at proving it can do the same for Type 2 diabetes.

Investigators tested this add-on drug in 1,402 patients with A1C levels between 7% and 11%, with a 400 mg dose beating a placebo in pushing a significant number of patients below the 7 mark — the magic number for glycemic control in diabetes. But we’ll have to wait for a scientific conference to get the details from inTandem3.

The important point for now is that Lexicon appears poised to pursue marketing approval for a novel drug that targets both SGLT-1 and SGLT-2. SGLT-2 drugs like Jardiance, Invokana and Farxiga have already made their mark on the market, blocking glucose absorption in the kidneys. But this therapy adds another target in the intestinal tract.

This may not revolutionize therapy, but in diabetes R&D — developing drugs for a mass audience of millions around the globe — every incremental step forward marks blockbuster potential.

Sanofi saw the promise and came in to bag the worldwide rights to the drug — leaving Lexicon with US co-promotion rights — with a $300 million upfront payment and $1.4 billion in potential milestones.

This has been a watershed year for Lexicon. Just a few months ago the biotech completed a marathon development program with an FDA approval of telotristat ethyl (which will be sold as Xermelo and was formerly known as LX1032) for carcinoid syndrome, which is linked with severe diarrhea.

Lonnel Coats

“These positive results represent an important milestone, further supporting sotagliflozin’s differentiated profile as a novel, oral anti-diabetic agent with potential to benefit people with type 1 diabetes,” said Lonnel Coats, Lexicon’s president and chief executive officer, in a prepared statement. “Sotagliflozin is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase III clinical trials in this population.”

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Sr. Manager, Regulatory Affairs, CMC
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