The pooled data results came five months after the FDA rejected Zynquista following a split advisory committee vote.
Shares of Texas-based Lexicon Pharmaceuticals shot up in after-market trading Thursday after the company announced positive 52-week cardiorenal data from a pooled analysis of its type 1 diabetes trials, Tandem1 and Tandem2.
The two trials were assessing the safety and efficacy of Zynquista (sotagliflozin) in adult patients. According to Lexicon and its developmental partner Sanofi, trial data showed that Zynquista demonstrated changes in clinical biomarkers such as estimated glomerular filtration rate (eGFR), hematocrit, serum albumin, uric acid, systolic blood pressure and urinary albumin-to-creatinine ratio. Those changes suggest Zynquista may reduce cardiovascular risk and progression of chronic kidney disease, the company said Thursday. The trial data also showed that Zynquista was associated with short- and long-term renal hemodynamic changes. Lexicon said after patients stopped taking Zynquista at the 52-week mark, eGFR was comparable to baseline and significantly higher than placebo in Zynquista-treated patients.
Zynquista, an oral dual inhibitor of SGLT1 and SGLT2, two proteins responsible for glucose regulation. demonstrated meaningful effects on markers of hemoconcentration and plasma uric acid, where biochemical changes have been linked to cardiorenal protection associated with SGLT2 inhibitors. Zynquista also demonstrated consistent lowering of blood pressure and urinary albumin-to-creatinine ratio (UACR). Additionally, Zynquista reduced uric acid in patients.
The trial results were published in Diabetes Care, the ADA’s peer-reviewed research journal dedicated to diabetes treatment and prevention.
For Lexicon, the publication of the data from the two trials comes five months after the U.S. Food and Drug Administration issued a Complete Response Letter for Zynquista as a treatment for type 1 diabetes. The CRL was not a complete surprise following a split vote from the advisory review committee assessing the safety and efficacy of the drug. In January, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted eight to eight on the drug’s overall benefits outweighing the risks. The drug was being developed as an adjunct to insulin to treat adults with type 1 diabetes. Lexicon believes that Zynquista could help diabetes patients manage and maintain blood sugar levels with a lower risk of hypoglycemia.
While the FDA rejected Zynquista, the European Medicines Agency gave the drug the green light in April. Approval was based on evidence including data from the inTandem clinical trial program, which included three Phase III clinical trials assessing the safety and efficacy of sotagliflozin, involving approximately 3,000 adults with inadequately controlled type 1 diabetes.
Lexicon has granted Sanofi an exclusive worldwide license to develop, manufacture and commercialize Zynquista. Lexicon remains responsible for all clinical development activities relating to type 1 diabetes and Sanofi is responsible for all clinical development activities of Zynquista for the treatment of type 2 diabetes.
