Lexicon provides business, pipeline update at JPMorgan conference

Lexicon Pharmaceuticals announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024. INPEFA Launch Positioned for Acceleration in 2024: Lexicon continues to focus on accelerating the launch of INPEFA, having recently strengthened and evolved its commercial organization to be better placed for success with recent leadership additions and a sales force in place of approximately 150 cardiovascular specialty representatives focused on high-volume prescribers and institutions. The company’s sales force has succeeded in driving demand well ahead of filled prescriptions in 2023 pending continuing progress in establishing broader market access and reimbursement. Further improving and expanding market access and reimbursement is a key area of focus in 2024, together with driving further prescription and prescriber growth and achieving favorable formulary decisions among integrated delivery networks. Lexicon aims to significantly increase market access coverage in the first half of 2024 and expects continued prescription and net sales growth throughout the year, accelerating in the second half of 2024. The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence. Clinical Data and FDA Feedback Support INPEFA Life Cycle Management Opportunity in HCM: Clinical data from INPEFA’s heart failure studies and its unique mechanism of inhibiting SGLT1 and SGLT2 support a life-cycle management opportunity in HCM, a condition of high unmet need that affects approximately one million people in the U.S. In discussions with the FDA, Lexicon has aligned on a protocol for a single Phase 3 study that could support a supplemental New Drug Application for an INPEFA label expansion encompassing patients with both obstructive and non-obstructive HCM. Exploration of Potential Path Forward in Type 1 Diabetes: Lexicon and the FDA agreed to pause the pending proceedings relating to Lexicon’s request for an administrative hearing on whether there were grounds for the FDA’s previous denial of the NDA for sotagliflozin in type 1 diabetes in order to engage in discussions, now underway, regarding a potential path forward for the approval of sotagliflozin in type 1 diabetes. LX9211 Late-Stage Development Underway, with Potential to Be First New Non-Opioid Drug for DPNP in Over Two Decades: An estimated 20 million patients in the U.S. experience neuropathic pain, and approximately 5 million patients experience DPNP, with the current standard of care often inadequate and involving undesirable side effects. LX9211 has the potential to be the first non-opioid approach with a novel mechanism in over two decades in this large, underserved market. LX9211 is distinguished in having established clinical success versus placebo in its Phase 2 proof-of-concept study, an important achievement enabling progression into late-stage development and pivotal studies. LX9211 is further distinguished in having achieved clinical success in a study, aligned with how new DPNP drugs are likely to be used in practice, in which patients were permitted to maintain one stable-dose DPNP therapy without being forced to withdraw from therapies that, although inadequate, may be providing benefit. Patient enrollment in the PROGRESS Phase 2b study is now underway, with data anticipated in Q2 2025.