NDA for Sotagliflozin on Track for May 2023 PDUFA date following Late-Cycle Review Meeting
LX9211 Demonstrates Consistent Results in Full Data from RELIEF-DPN-1 in Diabetic Peripheral Neuropathic Pain and Top-Line Data from RELIEF-PHN-1 in Post-Herpetic Neuralgia
Conference Call and Webcast at 5:00 pm Eastern Time
THE WOODLANDS, Texas, March 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones.
“We are on track for the PDUFA action date in May of this year for our NDA for sotagliflozin for the treatment of heart failure, as confirmed during this week’s FDA late-cycle review meeting,” said Lonnel Coats, Lexicon’s chief executive officer. “We believe the uniqueness of our data from the SOLOIST-WHF trial provides a point of clinical differentiation and provides a strong opportunity to launch into a growing market with recently adopted medical treatment guidelines recommending the use of SGLT inhibitors as a key pillar of heart failure treatment.”
“We continue to advance the science across our portfolio with the upcoming presentation of sotagliflozin-related analyses at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana, including a featured presentation on the time to clinical benefit of sotagliflozin in people with worsening heart failure. In parallel, we are equally excited about the clinical progress of our AAK1-inhibitor, LX9211. We plan to advance LX9211 into late-stage development in neuropathic pain, supported by data from Phase 2 proof-of-concept studies in diabetic peripheral neuropathic pain (DPN) and postherpetic neuralgia (PHN), both completed in 2022.”
Fourth Quarter Highlights
Sotagliflozin
- On November 6, a new analysis of results from the SOLOIST-WHF Phase 3 outcomes study of sotagliflozin was presented at the American Heart Association Scientific Sessions 2022 in Chicago, Illinois. The oral presentation was titled “The effect of the dual SGLT1 and 2 inhibitor sotagliflozin on cardiovascular mortality and hospital readmission rates for heart failure at 30- and 90-days post discharge in patients with type 2 diabetes hospitalized for worsening heart failure in the SOLOIST-WHF trial” and showed that treatment with sotagliflozin resulted in a significant relative risk reduction versus placebo of approximately 50% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at both 30 and 90 days following hospital discharge.
- A poster was presented at the American Society of Nephrology Kidney Week 2022 annual scientific meeting in Orlando, Florida on November 5. The poster was titled “Effect of sotagliflozin on albuminuria in patients with type 2 diabetes and chronic kidney disease” and described the results of a post hoc analysis of clinical data from the SCORED trial that showed sotagliflozin significantly reduced urine albumin-to-creatinine ratio (UACR) and had favorable effects on albuminuria progression and regression from a higher UACR category.
LX9211
- An oral presentation, titled “A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN-1),” was given at the 16th Annual Pain Therapeutics Summit in Washington, D.C. on November 14. The presentation of full data from the entire 11-week evaluation period of the study, which included a 5-week placebo run-off period following the initial 6-week treatment period, showed consistent and statistically significant treatment-period benefits in measures of particular importance in diabetic peripheral neuropathic pain for both dose arms compared to placebo, such as reductions in burning pain (p