Lexicon Pharmaceuticals to Announce Topline Results from Phase 2b PROGRESS Study Evaluating Pilavapadin (LX9211) in Adults with Diabetic Peripheral Neuropathic Pain

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Lexicon Pharmaceuticals (LXRX) has scheduled a conference call and webcast for March 3, 2025, at 8:00 a.m. ET to present topline results from their Phase 2b PROGRESS study. The study evaluates pilavapadin (LX9211), an oral, non-opioid investigational drug that inhibits adaptor-associated kinase 1 (AAK1), for treating moderate to severe diabetic peripheral neuropathic pain (DPNP) in adults.

The PROGRESS trial is designed as a dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension. Interested participants can access the live conference call and webcast through the company's investor relations website, with an archived version to be made available afterward.

Conference call and webcast at 8:00 a.m. ET on Monday, March 3, 2025

THE WOODLANDS, Texas, March 02, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company will hold a conference call and webcast on Monday, March 3, 2025 at 8:00 a.m. ET to share topline results from the Phase 2b PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating pilavapadin (LX9211), an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain (DPNP).

Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast on Monday, March 3, 2025, at 8:00 a.m. ET / 7:00 a.m. CT to review the details of this announcement. Participants can access the conference call live via webcast on the Events page of the Company’s website at https://investors.lexpharma.com/. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the Lexicon website.

About the PROGRESS Study
The PROGRESS study commenced in December 2023 and enrolled 496 adult patients with a diagnosis of diabetes (type 1 or type 2) and moderate to severe DPNP. The study was placebo-controlled with a primary endpoint of change from baseline to Week 8 in ADPS as compared to placebo and evaluated three treatment groups receiving once daily pilavapadin doses of 10 mg, 20 mg or 20 mg for seven days followed by 10 mg thereafter. Secondary endpoints included change from baseline to Week 8 in burning pain and pain interference on sleep. Study design permitted patients to remain on one stable-dose DPNP therapy (e.g. gabapentin, pregabalin or duloxetine) without withdrawing from therapies that, although inadequate, may be providing some benefit – aligning with how new DPNP drugs are likely to be used in practice.

About Diabetic Peripheral Neuropathic Pain (DPNP)
DPNP is a debilitating chronic complication of diabetes which can result in burning pain, numbness, and other symptoms in the hands, feet, legs and arms. There are approximately 9 million patients in the U.S. who are suffering with DPNP.

About Pilavapadin
Discovered using Lexicon’s unique approach to gene science, pilavapadin (LX9211) is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1, a novel target for neuropathic pain which inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of pilavapadin demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.

About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, obesity, cardiology, diabetes and other indications. For additional information, please visit www.lexpharma.com.  

For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com

FAQ

What is the purpose of Lexicon's Phase 2b PROGRESS study for LXRX stock?

The PROGRESS study evaluates pilavapadin (LX9211), a non-opioid drug, for treating diabetic peripheral neuropathic pain in adults, with results to be announced March 3, 2025.

When will LXRX announce the Phase 2b PROGRESS study results?

Lexicon Pharmaceuticals will announce the topline results on March 3, 2025, at 8:00 a.m. ET via conference call and webcast.

How can investors access LXRX's PROGRESS study results presentation?

Investors can access the live presentation through Lexicon's website at investors.lexpharma.com or register for dial-in numbers to participate in the Q&A.

What type of drug is LXRX's pilavapadin (LX9211)?

Pilavapadin is an oral, non-opioid investigational drug that works as an adaptor-associated kinase 1 (AAK1) inhibitor.