Despite winning an FDA approval in 2023 and gaining clarity in May on the regulatory path forward for its Type 1 diabetes prospect sotagliflozin, Lexicon Pharmaceuticals hasn’t had an easy go of it in recent years.
Now, following a strategic review of its commercial and pipeline programs, Lexicon has decided to channel its promotional efforts toward sotagiflozin in heart failure—where the drug is approved in the U.S. as Inpefa—and the molecule’s potential U.S. launch in patients with Type 1 diabetes and chronic kidney disease (CKD) under the market moniker Zynquista.
As part of the restructuring initiative, Lexicon will lay off more than 75 staffers, or approximately 50% of its current field force, by the end of September, the company said in a release.
All told, the move is expected to yield cost savings of around $40 million for 2025, while also ensuring certain clinical programs remain fully funded, Lexicon explained.
“Lexicon entered 2024 with a number of exciting commercial and pipeline opportunities,” CEO Mike Exton, Ph.D., said in a statement. “Over the past few weeks, we have been working on a plan to allocate resources across these opportunities, build on the successes of our capable commercial team and focus on where we have the potential to lead and succeed.”
Following an FDA rejection back in 2019, Lexicon recently announced plans to refile its U.S. application this year for Zynquista to help improve glycemic control in adults with Type 1 diabetes and CKD.
Elsewhere, the company plans to “fully” invest in R&D programs, including for sotagliflozin in hypertrophic cardiomyopathy, its candidate LX9211 in diabetic neuropathic pain—where the company expects a data readout in the first half of 2025—and investigational new drug-enabling studies of its prospect LX9851 for obesity and weight management.
Lexicon’s fortunes started to turn last May, thanks to an FDA approval for Inpefa as a once-daily pill for heart failure. The drug was specifically approved to curb the risk of heart failure in adults who have had the condition or have Type 2 diabetes, CKD and other cardiovascular risk factors.
As an SGLT1/SGLT2 inhibitor, Inpefa has shown tantalizing potential to block both SGLT2 in the kidneys and SGLT1 in the intestines.
Still, the regulatory path forward for sotagliflozin has been tortuous and filled with potholes.
Back in 2019, the drug was rebuffed by the FDA after Lexicon attempted to snare an approval in Type 1 diabetes patients who can’t control their blood sugar with insulin. Lexicon appealed the decision, but the FDA rejected it again in 2020, citing a safety concern.
Amid that pair of FDA rejections, sotagliflozin was approved in its diabetes indication as Zynquista in Europe, though, in 2022, Guidehouse Germany—which held Zynquista’s marketing rights in the bloc—withdrew the marketing authorization, saying it did not wish to commercialize the product.
Still, Lexicon has held out hope for its medicine in the U.S.
In March, after hearing recent regulatory feedback from the FDA, Lexicon said it planned to resubmit Zynqusita in the U.S. by the middle of the year.
The company has since done so and received an FDA action date for Zynquista on Dec. 20.
Lexicon is angling for an approval that will allow the med to be used as an adjunct to insulin therapy for Type 1 patients with CKD.