New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements In Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease
Lexicon Pharmaceuticals, Inc. (LXRX) announced positive results from a post hoc analysis of the inTandem3 Phase 3 trial, showing that sotagliflozin improved glycemic control in type 1 diabetes and CKD patients. The treatment led to reduced A1C, body weight, and blood pressure with similar safety to the overall study group. The data was presented at ATTD 2024, indicating potential for sotagliflozin as an adjunct to insulin therapy for this patient population.
From an endocrinological perspective, the post hoc analysis of sotagliflozin's effects on type 1 diabetes patients with chronic kidney disease (CKD) is significant. CKD is a common complication of diabetes and managing glycemic control in this subgroup is particularly challenging due to altered insulin kinetics and a higher risk of hypoglycemia. The ability of sotagliflozin to lower A1C—a marker of long-term blood glucose control—alongside reductions in body weight and systolic blood pressure without increasing severe hypoglycemia is noteworthy. These results suggest that sotagliflozin could address a critical unmet need in diabetes care, potentially leading to improved outcomes for this patient population.
Assessing the market implications of Lexicon Pharmaceuticals' announcement, the positive data on sotagliflozin for type 1 diabetes patients with CKD could have a favorable impact on the company's market position. Given the complexity of treating this subgroup, a drug that effectively manages multiple parameters of diabetes without compromising safety could see strong adoption rates. Moreover, the intention to resubmit their New Drug Application indicates confidence in the drug's profile, which could attract investor interest. If approved, sotagliflozin would likely capture a significant share of the diabetes treatment market, particularly among those with CKD—a demographic that has been underserved by current therapies.
Analyzing the research methodology, the use of a post hoc analysis allows for a focused examination of sotagliflozin's efficacy within a specific patient subgroup. However, it is important to note that post hoc analyses are not pre-specified and can be prone to statistical limitations. The fact that the results align with the overall cohort's outcomes adds credibility to the findings, but the data should ideally be validated in a prospective trial specifically designed for the CKD patient population. Additionally, the similar safety profile in the context of CKD is reassuring, as this group is often at greater risk for adverse events due to their compromised renal function.
03/12/2024 - 08:00 AM
THE WOODLANDS, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.
The efficacy and safety data were presented last week at ATTD 2024 - 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy.
Using data from the 24-week, multinational, placebo-controlled trial, the effects of sotagliflozin 400 mg daily added to insulin therapy on A1C, body weight, systolic blood pressure, eGFR, total insulin dose, adjudicated severe hypoglycemia and DKA were evaluated in a subgroup of patients (228 [16.3% ] of 1402]) with type 1 diabetes and CKD (eGFR <60 mL/min/1.73 m2 and/or UACR ≥30 mg/g).
Relative to placebo, treatment with sotagliflozin led to similar reductions in A1C, body weight and systolic blood pressure in the CKD and total cohorts. Sotagliflozin was associated with similar risks of severe hypoglycemia between the two cohorts.
“Our research team concluded that in patients with type 1 diabetes and CKD, treatment with sotagliflozin had similar A1C, body weight and systolic blood pressure lowering effects as compared to its effect on the total cohort” said David Z.I. Cherney, M.D., Ph. D., Professor in the Department of Medicine at the University of Toronto, and a contributing author of the abstract presented March 7, 2024, at ATTD.
“This research adds important data to the body of evidence supporting our plans to resubmit our New Drug Application for sotagliflozin as an adjunct to insulin therapy in people with type 1 diabetes and CKD,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We are optimistic that sotagliflozin may become an important new treatment option for this important population.”
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat diseases safely and effectively. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com .
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of sotagliflozin in type 1 diabetes. In addition, this press release may also contain forward-looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA ® (sotagliflozin) in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin in type 1 diabetes and other indications, LX9211 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2022 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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Lexicon Pharmaceuticals analyzed the inTandem3 Phase 3 trial in the press release.
The key findings were that treatment with sotagliflozin improved glycemic control, lowered A1C, body weight, and systolic blood pressure in type 1 diabetes and CKD patients.
The efficacy and safety data were presented at ATTD 2024 - 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy.
David Z.I. Cherney is a Professor in the Department of Medicine at the University of Toronto and a contributing author of the abstract presented at ATTD.
Craig Granowitz mentioned that sotagliflozin may become an important new treatment option as an adjunct to insulin therapy for type 1 diabetes and CKD patients.
