Shares of Lexicon Pharma ($LXRX) popped and then faded somewhat Friday morning after the biotech and its Big Pharma partners at Sanofi enthused over positive data from a Phase III study of their diabetes drug sotagliflozin.
Billed as a next-gen improvement on the SGLT2 approach to flushing blood sugar through urine, investigators say that two doses of their drug were able to reduce A1C levels by 0.43% and 0.49% in Type 1 patients, far better than the 0.08% reduction seen in the placebo group.
But this drug won’t compete against a placebo, and that could pose a problem.
There are already SGLT2 drugs on the market. Invokana-canagliflozin, Farxiga-dapagliflozin, and Jardiance-empagliflozin are approved for Type 2 but not Type 1, though there are plans to push for that amid reports of growing off-label use, despite some issues with alarming side effects. But Sanofi and Lexicon believe that they can improve on their performance with a drug that targets SGLT2 as well as SGLT1. Late-stage testing for Type 2 is coming up.
They haven’t proved that, though. In Lilly’s late-stage study of Jardiance, the drug lowered A1C by 0.64%, and they’ve also backed it up with new data that the drug reduces the risk of cardiovascular events.
Lexicon shares initially rocketed up 48% on the data, then lost much of that gain with a 20% surge to its credit in premarket trading.
Sanofi, which has been struggling to protect its blockbuster diabetes business, in-licensed sotagliflozin last year in a $1.7 billion deal that included a hefty $300 million up front. And execs were only too happy to applaud the results from the first Phase III.
So were Lexicon investors, who bid up the biotech’s shares by 51% Friday morning.
Noted Jorge Insuasty, senior vice president and head of global development at Sanofi:
“These top-line results highlight potential benefits of sotagliflozin when treating adults with type 1 diabetes. We congratulate our partners on this positive outcome and look forward to further exploring this compound for the treatment of adults with type 2 diabetes when Sanofi begins the Phase 3 program later this year.”
There were 268 patients in the placebo arm, 263 patients in the 200mg dose arm and 262 patients in the 400mg dose arm.
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