Canagliflozin Hemihydrate

Lexicon’s Zynquista (sotagliflozin) is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). Image Credit: MacroEcon / Shutterstock. Lexicon Pharmaceuticals reaffirmed its plans to seek approval for Zynquista (sotagliflozin) as an adjunct treatment to insulin in type 1 diabetes (T1D) and chronic kidney disease (CKD) as part of its Q1 financial report. The US-based company expects to resubmit the new drug application (NDA) for Zynquista to the Food and Drug Administration (FDA), following feedback from the agency, by mid-2024. In 2019, the FDA declined to approve the therapy citing safety concerns following a split 8-8 vote from its advisory committee . The FDA advisory committee was particularly concerned about the risk of diabetic ketoacidosis, a serious complication that can become life-threatening if urgent treatment is not administered. The FDA rejection also resulted in Sanofi pulling out of the licensing agreement for Zynquista. Still, Lexicon was able to get approval in 2019 for Zynquista as an adjunctive treatment to insulin in T1D and CKD from the European Medicine Agency (EMA). However, in 2022, the authorisation was withdrawn by the holders of Zynquista’s marketing rights in Europe, Guidehouse Germany, with the company saying it did not wish to “market the product in the EU for commercial reasons”. Zynquista is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2), which play a role in glucose uptake and reabsorption. The drug was approved by the FDA to reduce the risk of cardiovascular death and heart failure. It was also approved for use in patients with type 2 diabetes, CKD, and other underlying cardiovascular risk factors. It is marketed as Inpefa for the cardiovascular disease indication. See Also: Vertex Pharmaceuticals gets grant for treatment of alpha-1 antitrypsin deficiency with compound of formula (i) Ono Pharmaceutical gets grant for compound for treating disorders associated with TREK-1 and TREK-2 dysfunction Lexicon is also evaluating sotagliflozin as a treatment for hypertrophic cardiomyopathy, with a Phase III trial planned to start in mid-2024. The company has reported $355.6m in cash reserves as of 31 March. If Zynquista gets approved, it will face competition not only from other SGLT-2 inhibitors , including AstraZeneca ’s Farxiga (dapagliflozin), Boehringer Ingelheim’s Jardiance (empagliflozin) and Johnson & Johnson ’s Invokana (canagliflozin), but also from newer innovative therapies such as islet cell transplantation . In June 2023, the FDA approved the first-ever islet cell therapy for T1D, CellTrans’ Lantidra (donislecel). Other therapies in Lexicon’s portfolio include LX9211, a non-opioid therapy for diabetic peripheral neuropathic pain; and LX9851, a treatment for obesity and weight management. The company is evaluating LX9211 in a Phase II PROGRESS trial (NCT06203002), with the topline data expected in Q2 2025.

RALEIGH, N.C., Jan. 10, 2024 /PRNewswire/ -- A new study, "1,5-Anhydroglucitol: A Novel Biomarker of Adherence in Sodium -Glucose Cotransporter 2 Inhibitors," was published online on December 13, 2023, in Diabetes Care, a journal from the American Diabetes Association. The study was conducted by Elizabeith Selvin, PhD, MPH, at the Johns Hopkins Bloomberg School of Public Health. The objective of the study was to evaluate 1,5-anydroglucitol (as measured by the GlycoMark blood test) as a biomarker of Sodium -Glucose Cotransporter 2 Inhibitors (SGLT2i) drug adherence by analyzing users and non-users of SGLT2i in adults with diabetes from the Atherosclerosis Risk in Communities (ARIC) Study. In the study, very low 1,5-anhydroglucitol values were reported in SGLT2i users compared to non-users. The authors of the study conclude, "The very low blood concentrations of 1,5-anhydroglucitol in this community-based cohort support that 1,5-anhydroglucitol may be a useful biomarker of SGLT2i use. Our findings suggest that 1,5-anhydroglucitol may be useful in clinical research and trials as a marker of adherence." This new study data is consistent with previously reported studies which indicate that 1,5-anhydroglucitol may be useful for evaluating short-term effectiveness and assessing patient compliance of SGLT-2i drugs. One such study, "GlycoMark 1,5-Anhydroglucitol Values in Patients Taking SGLT-2 Inhibitors," was recently presented at the American Diabetes Association (ADA) Scientific Sessions. In this study, clinical investigators from Aveon Health (Scottsdale, AZ) conducted a review of their patients treated with an SGLT-2 inhibitor and their corresponding GlycoMark test results. Consistent with the data from Johns Hopkins, very low 1,5-anhydroglucitol values were reported in SGLT2i users relative to non-users. In another study, "1,5-anhydroglucitol is a good predictor for the treatment effect of the Sodium-Glucose cotransporter 2 (SGLT-2) inhibitor in Japanese patients with type 2 diabetes mellitus (Journal of Clinical and Translational Endocrinology)," 1,5-anhydroglucitol was the most reliable indicator of SGLT2i drug effectiveness – with the study authors stating that "1,5-anhydroglucitol has detective ability more useful for patients than HbA1c value or eGFR value." SGLT-2 inhibitors are a relatively new and popular class of drugs for patients with type 2 diabetes. Medicines in the SGLT-2 inhibitor class include canagliflozin, dapagliflozin, emagliflozin, and ertugliflozin. About GlycoMark® Test GlycoMark is an FDA-cleared and CE-marked non-fasting blood test. Since its discovery, the GlycoMark test, a quantitative test for 1,5-Anhydroglucitol (1,5-AG), has been described in more than 1,300 scientific and medical publications. GlycoMark is available at major reference laboratories in the United States and worldwide. About Precision Diabetes, Inc. (PDI) Precision Diabetes, Inc. (Raleigh, North Carolina) is the exclusive supplier of the GlycoMark test in the U.S., Europe, Australia, the Asia-Pacific Region, the Middle East, and Mexico. Precision Diabetes is an emerging leader in enabling precision medicine for diabetes using novel diabetes biomarkers and algorithms. The company's mission is to revolutionize the diagnostic assessment of diabetes by providing a spectrum of unique diabetes tests, spanning the risk of developing diabetes to developing diabetes complications. More information is available at . MEDIA CONTACT Juliana Button 919-390-1391 jbutton@precisiondiabetesinc.com SOURCE Precision Diabetes, Inc.