Lexicon Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)
Rhea-AI Summary
Lexicon Pharmaceuticals announced the completion of patient enrollment in the PROGRESS Phase 2B study evaluating LX9211 for diabetic peripheral neuropathic pain (DPNP). The study exceeded its enrollment target by 20%, successfully recruiting 494 patients, and finished eight weeks ahead of schedule. LX9211 is a novel, oral selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). The strong interest in trial participation demonstrates significant demand for new non-opioid DPNP treatments. Top-line data is expected in Q1 2025.
Positive
- Enrollment exceeded target by 20% (494 patients vs planned)
- Study completed 8 weeks ahead of schedule
- Strong patient interest indicates high market demand for the treatment
Negative
- Results not expected until Q1 2025
Insights
The completion of enrollment for the PROGRESS Phase 2B study of LX9211 represents a significant milestone for Lexicon Pharmaceuticals. The 20% over-enrollment to 494 patients not only increases statistical power but also demonstrates strong market demand for new DPNP treatments. The study's accelerated enrollment, finishing 8 weeks ahead of schedule, suggests high physician and patient interest in this non-opioid therapeutic option.
The trial's robust enrollment strengthens the potential validity of upcoming results and positions LX9211 well for future Phase 3 planning. DPNP affects approximately 30-50% of diabetes patients, representing a substantial market opportunity. If successful, LX9211's novel mechanism as an AAK1 inhibitor could provide a much-needed alternative to current treatments, which often have efficacy or concerning side effects.
Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule
Top-line Data Expected in Q1 2025
THE WOODLANDS, Texas, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the 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 LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP).
The study successfully enrolled 494 patients, approximately 20 percent more than originally targeted, marking a significant milestone in the trial and increasing study power. Top-line data from PROGRESS is expected to be announced in Q1 2025.
"We are pleased to have completed enrollment for the PROGRESS study of LX9211 in DPNP, a condition for which there is significant need for new, non-opioid treatment options," said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. "The strong interest in this study resulted in enrollment significantly exceeding the target and completion of enrollment eight weeks ahead of schedule, underscoring the urgent demand in DPNP. We are confident that the greater-than-expected enrolled patient population will lead to critical insights, inform our Phase 3 design and add to the body of evidence supporting the use of LX911 in treating neuropathic pain and we look forward to sharing top-line findings from the study early next year."
About the PROGRESS Study
PROGRESS commenced in December of 2023 with the goal of enrolling adult patients with a diagnosis of diabetes (type 1 or type 2) with moderate to severe DPNP. The study is placebo-controlled with a primary endpoint of reduction of Average Daily Pain Score (ADPS) at 8 weeks. Secondary endpoints include change from baseline in burning pain and pain interference with sleep. Study design permitted patients 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 – aligning with how new DPNP drugs are likely to be used in practice.
About DPNP
DPNP is a type of nerve damage caused by chronically high blood sugar and is a major disabling and devastating consequence of long-term diabetes. It can result in pain, numbness, and other symptoms in the hands, feet, legs, and arms. There are approximately 20 million patients in the U.S. who are suffering with some type of neuropathic pain, of which about 5 million have DPNP.
About LX9211
Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP.
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 treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Investors and Media
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
FAQ
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