Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference - Seite 2

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 (sNDA) 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 (gabapentin, pregabalin or duloxetine) 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.

Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation. Jeff Wade, Lexicon’s president and chief financial officer, Tom Garner, Lexicon’s senior vice president and chief commercial officer, and Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, will also participate.