Core Insights - The study published in the Journal of American Society of Nephrology indicates that sotagliflozin, when added to insulin, effectively lowers glycated hemoglobin (HbA1c) in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) similarly to those without CKD [1][2] - Sotagliflozin shows a lower to neutral risk of severe hypoglycemia and does not significantly increase the risk of diabetic ketoacidosis (DKA) [1][2] Study Findings - The research utilized data from the 52-week inTandem1 and 2 trials and the 24-week inTandem3 trial to evaluate the effects of sotagliflozin (200mg or 400mg daily) versus placebo on HbA1c, body weight, systolic blood pressure, insulin dose, and safety endpoints [3] - In the inTandem1 and 2 trials, 237 out of 1,575 patients had CKD, while 228 out of 1,402 patients in the inTandem3 trial had CKD [4] - At week 24, significant placebo-adjusted reductions in HbA1c were observed in both CKD and non-CKD subgroups, with reductions of -0.4% for both 200mg and 400mg doses in the non-CKD subgroup and -0.4% and -0.3% in the CKD subgroup [5] - The incidence of severe hypoglycemia at week 52 was lower in the CKD subgroup receiving sotagliflozin (7% for 200mg and 4% for 400mg) compared to placebo (17%) [5] - The incidence of adjudicated DKA at week 52 in the CKD subgroup was 1%, 5%, and 3% for placebo, 200mg, and 400mg doses, respectively [5] Additional Insights - The study co-author emphasized the urgent need for new treatment options for patients with T1D and CKD, highlighting that sotagliflozin could provide significant benefits if approved by the FDA [7] - The FDA has set a target action date of December 20, 2024, for the approval of ZynquistaTM (sotagliflozin) [8] - Sotagliflozin is an oral inhibitor of SGLT1 and SGLT2, which are responsible for glucose regulation, and has been studied in various patient populations, including approximately 20,000 patients across multiple clinical studies [8]

THE WOODLANDS, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Advisory Committee voted ...

THE WOODLANDS, Texas, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Jeff Wade, president and chief operating officer, has decided to step down to pursue new opportunities outside of Lexicon, effective September 30, 2024. A search for a new chief financial officer is ongoing. For the past 25 years, Mr. Wade has served in a series of finance, corporate development, administrative and legal leadership positions at Lexicon, serving most recently as presiden ...

Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin TIR measures approach target set by American Diabetes Association Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated tha ...

THE WOODLANDS, Texas, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Lexicon management will participate in the following investor conferences taking place in September: H.C. Wainwright 26th Annual Global Investment Conference – Tuesday, September 10, 2024 at 12:30pm ET 2024 Cantor Fitzgerald Global Healthcare Conference – Tuesday, September 17, 2024 at 8:35am ET A simultaneous webcast for these events will be available in the "Events" section of the Lex ...

Lexicon Pharmaceuticals, Inc. (LXRX) announced that the FDA plans to hold an advisory panel meeting to give a recommendation on whether to approve Zynquista (sotagliflozin), which has been developed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to be held on Oct 31, 2024. However, despite scheduling an advisory committee meeting, the FDA did not chang ...

Lexicon Pharmaceuticals, Inc. (LXRX) announced a strategic review, including the reprioritization of its current portfolio of marketed products and pipeline candidates and reducing operational expenses, to drive future business growth. As part of the portfolio reprioritization, LXRX is looking to reduce its current headcount by almost 50%, which is likely to be completed later in the ongoing quarter. Owing to this, the company expects to reduce its operating costs by $40 million in 2025. The company also re ...

Company to Focus on Targeted Promotion of INPEFA® in Heart Failure While Prioritizing Investment in the Potential Launch of ZYNQUISTA™ Efforts Expected to Reduce 2025 Operating Costs by $40 Million THE WOODLANDS, Texas, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following a strategic review of its commercial and pipeline programs, it will refocus resources across the portfolio in support of opportunities where the company believes it can have the gr ...

THE WOODLANDS, Texas, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that three poster presentations will be delivered during the 2024 Annual Conference of the Association of Diabetes Care & Education Specialists being held August 9 - 12, 2024 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. Posters will be displayed in the poster area of Exhibition Hall B from Friday, August 9 through Sunday, August 12. All three presentations will occur o ...

THE WOODLANDS, Texas, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that three poster presentations will be delivered during the 2024 Annual Conference of the Association of Diabetes Care & Education Specialists being held August 9 - 12, 2024 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. Posters will be displayed in the poster area of Exhibition Hall B from Friday, August 9 through Sunday, August 12. All three presentations will occur on ...