Content Detail

• Content META

  Title	Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings
  ID	13513706
  External ID	110000803
  Author
  Published Date	Sept. 17, 2025, 6 a.m.
  Summary	This is a paid press release. Contact the press release distributor directly with any inquiries. Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPN
  Tags
  URL	https://finance.yahoo.com/news/pilavapadin-provides-meaningful-pain-reduction-110000803.html
  Sentiment	Negative: 0.02281    Neutral: 0.14575    Positive: 0.83144
  Relevance	0.01047

• Content Details

  Content ID	8521467
  Key	f4c9b9cb-9347-417a-9c4f-2feb5f782b90
  Content	This is a paid press release. Contact the press release distributor directly with any inquiries. Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings Lexicon Pharmaceuticals, Inc. Wed, Sep 17, 2025, 7:00 AM 4 min read LXRX Lexicon Pharmaceuticals, Inc. Pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 11 and was well tolerated in PROGRESS Phase 2b study THE WOODLANDS, Texas, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the presentation of clinical data from the company’s Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain (DPNP) at two medical meetings: “New Promise for Painful Diabetic Neuropathy: Results from recently finished clinical trials of Pilavapadin, an oral, non-opioid, AAK1 inhibitor for diabetic peripheral neuropathic pain” was presented on Saturday, September 13, 2025, during an oral presentation at the NEUROdiab Annual Meeting. “Pilavapadin, an oral, non-opioid, AAK1 inhibitor for diabetic peripheral neuropathic pain (DPNP): results from a Phase 2b, dose-ranging, randomized, placebo-controlled, multicenter study” was presented on Wednesday, September 17, 2025, during an oral presentation at the 2025 European Association for the Study of Diabetes (EASD) Annual Meeting. “The data presented at NEUROdiab and EASD provide additional support for our understanding of pilavapadin’s profile, as well as its potential as a much-needed new therapy for DPNP,” said Suma Gopinathan, Lexicon’s Senior Vice President, Discovery. “Pilavapadin has potential to become the first non-opioid, oral medication approved for DPNP in over two decades. We look forward to Phase 3 trials for this potential new therapy.” Study Results The Phase 2b, dose-finding PROGRESS study evaluated once daily pilavapadin doses of 10 mg, 20 mg, or 20 mg for seven days followed by 10 mg thereafter, in adults with DPNP. Based on results of the study, Lexicon identified pilavapadin 10 mg once daily as the most clinically meaningful dose. In a post-hoc analysis of the PROGRESS data, excluding the 20 mg arm, the pilavapadin 10 mg dose arms demonstrated nominally significant separation from placebo (p < 0.05). Additionally, a clinically meaningful, two-point reduction from baseline in average daily pain scores (ADPS) was observed by week 11. The pilavapadin 10 mg dose was well tolerated with minimal discontinuations. “DPNP is a highly prevalent, but often overlooked, debilitating, chronic complication of diabetes in need of new non-opioid treatments,” said Rodica Pop-Busui M.D., Ph.D., Jordan Schnitzer Chair in Diabetes, Professor of Medicine and Division Head, Endocrinology, Diabetes and Clinical Nutrition Director, Harold Schnitzer Diabetes Center, Oregon Health & Science University and lead investigator of the PROGRESS study. “AAK1 inhibition represents a promising approach to treating this condition, inducing analgesia by dampening post-neuronal excitability. The Phase 2b PROGRESS study, as well as the prior Phase 2a RELIEF-DPN-1 study, demonstrate that pilavapadin 10 mg was effective in reducing pain scores while maintaining a safety profile in line with current standard of care.” Story Continues DPNP can result in burning pain, numbness, and other symptoms in the hands, feet, legs, and arms. There are approximately nine million patients in the U.S. who are suffering with DPNP. DPNP affects an estimated 30% of patients with type 1 diabetes and 50% of patients with type 2 diabetes. Lexicon announced topline results from the PROGRESS trial in March of 2025 and looks forward to presenting additional analyses from its Phase 2 studies at the upcoming Pain Therapeutics Summit October 13-14. 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 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 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, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of pilavapadin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization 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, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of 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 approved products and other 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, 2024, as 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. For Investor and Media Inquiries : Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com View Comments Terms and Privacy Policy Privacy Dashboard More Info
  Content Reference URL	None

• Publisher

  Publisher Name	Financial Planning (#6135)
  Publisher URL	https://finance.yahoo.com
  Description	None
  Trust Flow Score	83
  Citation Flow Score	57

• Data Source

  Data Source Name	Yahoo Finance News (#2)
  Data Source Type	news
  Data Source URL	https://finance.yahoo.com/
  Description	Yahoo! Finance is a media property that is part of the Yahoo! network. It provides financial news, data and commentary including stock quotes, press releases, financial reports, and original content. It also offers some online tools for personal finance management.
  Weight	10