Lexicon Pharmaceuticals is advancing its clinical pipeline with promising developments for LX9211 in diabetic peripheral neuropathic pain (DPNP) and sotagliflozin in cardiovascular risk reduction. The company has completed enrollment in the Phase 2b PROGRESS trial for LX9211 and published data in The Lancet Diabetes & Endocrinology highlighting the benefits of sotagliflozin.
LX9211 for Diabetic Peripheral Neuropathic Pain
Lexicon's LX9211, a novel oral non-opioid therapy, is being investigated for the treatment of DPNP. The Phase 2b PROGRESS trial, designed as a dose-ranging, randomized, double-blind, placebo-controlled study, has completed enrollment, exceeding its target by 20% due to strong interest from patients and investigators. Top-line data from the trial are expected in Q1 2025.
Leerink Partners analyst Roanna Ruiz maintains a Buy rating on Lexicon (LXRX), citing the potential of LX9211 to address the unmet need in the DPNP market. The strategic decision to improve tolerability by eliminating the loading dose, along with positive feedback from key opinion leaders, supports the potential of LX9211 as a standalone or combination therapy for pain management.
H.C. Wainwright also reiterated a Buy rating on LXRX with a $4.00 price target.
Sotagliflozin's Cardiovascular Benefits
Data published in The Lancet Diabetes & Endocrinology reinforce the clinical advantages of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in reducing major adverse cardiovascular events (MACE). The study aligns with research presented at the American Society of Hematology, demonstrating clinical benefits compared to empagliflozin.
Post-hoc analysis presented at the American Heart Association's (AHA) Sessions 2024 also demonstrated sotagliflozin benefits across a broad spectrum of heart failure patient populations. These study results add to the growing body of evidence differentiating sotagliflozin within the SGLT inhibitor class.
Strategic Repositioning
Lexicon Pharmaceuticals is strategically restructuring to focus on clinical development, prioritizing its R&D pipeline, including ongoing studies in DPNP, heart failure, and obesity. This repositioning includes eliminating the commercial organization and rationalizing operations across all functions, expected to reduce 2025 operating costs by $100 million.
Other Key Updates
- Scott Coiante was appointed as Senior Vice President and Chief Financial Officer, effective January 2, 2025.
- Ivan H. Cheung was elected to the Board of Directors.
- The company received a complete response letter from the FDA regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
