THE WOODLANDS, Texas - Lexicon Pharmaceuticals , Inc. (NASDAQ: NASDAQ:LXRX) announced positive results from a Phase 3 clinical trial of sotagliflozin, a medication designed to improve glucose control in type 2 diabetes patients on insulin. The study findings are scheduled for presentation on September 12 at the European Association for the Study of Diabetes Annual Meeting in Madrid, Spain.
The SOTA-INS CGM trial evaluated the effects of sotagliflozin on time-in-range (TIR) metrics, which indicate the percentage of time a patient's blood glucose levels are within the target range. The American Diabetes Association recommends a TIR of at least 70%. The trial showed that sotagliflozin, at both 200 mg and 400 mg daily doses, approached this target, enhancing TIR and reducing glucose variability.
Sotagliflozin is a dual inhibitor of sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1), which are involved in glucose regulation. The drug has previously shown efficacy in type 1 diabetes as an adjunct to insulin therapy in the inTandem program. Despite the positive outcomes, Lexicon stated they are not pursuing an indication for type 2 diabetes treatment with sotagliflozin, but the study contributes to the evidence supporting the value of SGLT1 inhibition.
Dr. Craig Granowitz, Lexicon's senior vice president and chief medical officer, expressed optimism about the drug's potential to offer additional therapeutic options for glycemic control in type 2 diabetes patients.
Lexicon, known for pioneering medicines through gene science, has already launched INPEFA® (sotagliflozin) in the U.S. and continues to develop other drug candidates in areas such as neuropathic pain and metabolism.
This information is based on a press release statement from Lexicon Pharmaceuticals and is intended for informational purposes only. The company's forward-looking statements involve risks and uncertainties, including the potential therapeutic and commercial value of its drug candidates, which may differ materially from future results.
In other recent news, Lexicon Pharmaceuticals has reported a net loss of $53.4 million in their second quarter 2024 earnings call, despite growth in their INPEFA business. The company revealed revenues of $1.6 million for the quarter, primarily from INPEFA sales. On the development front, Lexicon is set to meet with the FDA's Endocrinologic and Metabolic Drugs Advisory Committee for a review of Zynquista, a drug intended for glycemic control in adults with type 1 diabetes and chronic kidney disease.
Additionally, Lexicon has initiated patient enrollment for the Phase 3 SONATA trial of sotagliflozin in hypertrophic cardiomyopathy. The company is also advancing LX9851 into preclinical development for obesity and weight management. In line with these developments, Lexicon announced a strategic shift to focus on its heart failure drug, INPEFA, and the anticipated launch of ZYNQUISTA. This move is expected to save around $40 million in operating costs for 2025, while also reducing its field force by approximately 50%.
Despite these changes, Lexicon remains committed to funding its research and development programs. As part of these efforts, the company expects top-line data for the LX9211 study in diabetic peripheral neuropathic pain by Q2 2025 and is preparing for the potential launch of Zynquista in early 2025.
InvestingPro Insights
As Lexicon Pharmaceuticals (NASDAQ: LXRX) continues to make strides in the medical field with its recent positive trial results for sotagliflozin, investors and industry observers are closely monitoring the company's financial health and market potential. According to InvestingPro data, Lexicon has a market capitalization of $603.69 million, which reflects the market's current valuation of the company. Despite a significant revenue growth of 794.59% over the last twelve months as of Q2 2024, Lexicon's gross profit margin stands at -1674.48%, indicating challenges in converting its revenues into actual profit.
InvestingPro Tips also shed light on some critical aspects of Lexicon's financial position. Notably, the company holds more cash than debt on its balance sheet, providing it with a degree of financial flexibility. Additionally, analysts have revised their earnings upwards for the upcoming period, suggesting a positive outlook on the company's performance. On the other hand, Lexicon is quickly burning through its cash reserves and suffers from weak gross profit margins, which could be areas of concern for potential investors.
For those interested in a deeper analysis, InvestingPro offers a range of additional tips, including insights into sales growth expectations and profitability forecasts. Currently, there are 9 more InvestingPro Tips available for Lexicon Pharmaceuticals, which can be accessed for a comprehensive understanding of the company's financial and market position.
Investors looking to make informed decisions may find these insights particularly valuable in the context of Lexicon's recent clinical achievements and its ongoing efforts to develop innovative treatments. The company's next earnings date is set for November 6, 2024, which will provide further details on its financial performance and operational progress.
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