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 StudyPROGRESS 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 DPNPDPNP 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 LX9211Discovered 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 StatementThis 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 MediaLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

临床2期快速通道临床结果

2024-11-22

·GlobeNewswire-Health Care

Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity Efforts Expected to Reduce 2025 Operating Costs by $100 Million Conference Call and Webcast at 9:00 am ET THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact. This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s 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). The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. "While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities." Details of the Strategic Restructuring Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA® and all planned commercial activities for ZYNQUISTA.A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st.INPEFA to continue to be manufactured and made available to patients and existing prescribers.An expected reduction of 2025 full year operating costs by $100 million. This amount is in addition to the $40 million in expected 2025 cost savings announced in August as part of a realignment of resources. Reemerging as a Clinical Development-Focused Company Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including: The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data anticipated in Q1 2025.The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), with enrollment underway.IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders.Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications.Exploring strategic partnerships to advance and accelerate the value of our pipeline. Conference Call and Webcast InformationLexicon management will hold a live conference call and webcast today at 9:00 am ET / 8:00 am 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://www.lexpharma.com/media-center/events. 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 website for 14 days. 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, metabolism and other therapeutic areas. 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. Investor ContactLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com Media ContactMolly DevlinReal Chemistrycorpcomm@lexpharma.com

申请上市临床2期临床3期

2024-11-22

·Firstwordpharma

Lexicon hunkers down on R&D after Zynquista's failure to launch

Lexicon Pharmaceuticals' diabetes hopeful Zynquista (sotagliflozin) has once again been shot down by the FDA — and this time, the drug developer is waving the white flag. The firm disclosed Friday that it has received a "deficiencies preclude discussion" letter from the FDA pointing out issues with its regulatory application that prevent any conversations regarding labelling for the drug, and/or post-marketing requirements.In light of the setback, Lexicon is closing down all commercialisation activities and slashing 60% of its workforce, effective Dec. 31, to preserve cash for ongoing R&D efforts.The strategic shift comes about five years after the US regulator first rejected Lexicon's bid for Zynquista as an adjunct to insulin in adults with type 1 diabetes (T1D), due to a potentially increased risk of diabetic ketoacidosis.While its second filing sought to improve the risk-benefit ratio by narrowing its focus to patients with T1D and chronic kidney disease, some safety concerns remained. The drug received a negative vote from an FDA advisory committee last month, with one member, NIH's Martha Nason, voicing concerns over the supporting data showing "too much uncertainty about potentially fatal consequences."Now, the company is turning its focus towards its late-stage development pipeline. Investors reacted positively to the strategic shift, boosting the company's shares up over 10% Friday afternoon. Coming up through the pipelineAlthough Lexicon did notch a win last year for sotagliflozin when it was approved as Inpefa for patients with heart failure, Friday's reprioritisation will see it also wind down all promotional efforts for the the oral SGLT2/1 inhibitor in the indication and completely eliminate its commercial field team. The company noted that Inpefa will continue to be manufactured and available to patients.The changes are expected to reduce operating costs by $100 million next year, in addition to $40 million that it expects to save from an earlier round of layoffs, announced in August, that affect 75 staffers. With its streamlined operations, Lexicon plans to focus on a pair of clinical programmes: the Phase IIb PROGRESS study of LX9211, an AAK1-targeting oral small molecule in diabetic peripheral neuropathic pain, and the pivotal Phase III SONATA HCM trial of sotagliflozin to treat hypertrophic cardiomyopathy.Topline data from PROGRESS are expected in the first quarter of 2025; enrollment is underway for SONATA HCM. Lexicon is also conducting IND-enabling studies of LX9851, a non-incretin oral candidate, in obesity and associated cardiometabolic disorders.

临床2期临床3期上市批准

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