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 However, in 2022, the authorisation was withdrawn by the holders of Zynquista’s marketing rights in Europe, Guidehouse Germany, with the company saying it did not wish to “market the product in the EU for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.

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.

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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.