Lexicon Pharmaceuticals to Announce Topline Results from Phase 2b PROGRESS Study Evaluating Pilavapadin (LX9211) in Adults with Diabetic Peripheral Neuropathic Pain
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participants can access the live conference call and webcast through the company's investor relations website, with an archived version to be made available afterward.
Lexicon Pharmaceuticals (LXRX) ha programmato una conferenza telefonica e un webcast per il 3 marzo 2025, alle 8:00 a.m. ET, per presentare i risultati preliminari del loro studio PROGRESS di Fase 2b. Lo studio valuta pilavapadin (LX9211), un farmaco sperimentale orale non oppioide che inibisce la chinasi associata all'adattatore 1 (AAK1), per il trattamento del dolore neuropatico periferico diabetico (DPNP) da moderato a grave negli adulti.
Il trial PROGRESS è progettato come uno studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, con un'estensione in aperto. I partecipanti interessati possono accedere alla conferenza telefonica dal vivo e al webcast tramite il sito web delle relazioni con gli investitori dell'azienda, con una versione archiviata disponibile successivamente.
Lexicon Pharmaceuticals (LXRX) ha programado una llamada de conferencia y un webcast para el 3 de marzo de 2025, a las 8:00 a.m. ET, para presentar los resultados preliminares de su estudio PROGRESS de Fase 2b. El estudio evalúa pilavapadin (LX9211), un medicamento en investigación oral no opioide que inhibe la quinasa asociada a adaptadores 1 (AAK1), para tratar el dolor neuropático periférico diabético (DPNP) de moderado a grave en adultos.
El ensayo PROGRESS está diseñado como un estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos y una extensión abierta. Los participantes interesados pueden acceder a la llamada de conferencia en vivo y al webcast a través del sitio web de relaciones con inversores de la empresa, con una versión archivada disponible posteriormente.
Lexicon Pharmaceuticals (LXRX)는 2025년 3월 3일 오전 8시(ET)에 2b 단계 PROGRESS 연구의 주요 결과를 발표하기 위한 컨퍼런스 콜 및 웹캐스트를 예정하고 있습니다. 이 연구는 성인의 중등도에서 중증의 당뇨병성 말초 신경병증(DPNP) 치료를 위해 아답타 연관 키나제 1(AAK1)을 억제하는 경구 비오피오이드 실험 약물인 필라바파딘 (LX9211)을 평가합니다.
PROGRESS 시험은 용량 범위, 무작위 배정, 이중 맹검, 위약 대조, 병렬 그룹, 다기관 연구로 설계되었으며 공개 라벨 연장이 포함됩니다. 관심 있는 참가자는 회사의 투자자 관계 웹사이트를 통해 실시간 컨퍼런스 콜 및 웹캐스트에 접근할 수 있으며, 이후 아카이브된 버전도 제공될 예정입니다.
Lexicon Pharmaceuticals (LXRX) a prévu une conférence téléphonique et un webcast pour le 3 mars 2025, à 8h00 ET, afin de présenter les résultats préliminaires de leur étude PROGRESS de Phase 2b. L'étude évalue pilavapadin (LX9211), un médicament expérimental oral non opioïde qui inhibe la kinase associée à l'adaptateur 1 (AAK1), pour le traitement de la douleur neuropathique périphérique diabétique (DPNP) modérée à sévère chez les adultes.
L'essai PROGRESS est conçu comme une étude multicentrique, randomisée, en double aveugle, contrôlée par placebo, à groupes parallèles, avec une extension en ouvert. Les participants intéressés peuvent accéder à la conférence téléphonique en direct et au webcast via le site Web des relations avec les investisseurs de l'entreprise, avec une version archivée qui sera disponible par la suite.
Lexicon Pharmaceuticals (LXRX) hat eine Telefonkonferenz und einen Webcast für den 3. März 2025 um 8:00 Uhr ET angesetzt, um die vorläufigen Ergebnisse ihrer Phase 2b PROGRESS-Studie zu präsentieren. Die Studie bewertet Pilavapadin (LX9211), ein orales, nicht-opioides Prüfmedikament, das die Adapter-assoziierte Kinase 1 (AAK1) hemmt, zur Behandlung von mäßigen bis schweren diabetischen peripheren neuropathischen Schmerzen (DPNP) bei Erwachsenen.
Die PROGRESS-Studie ist als dosierungsabhängige, randomisierte, doppelblinde, placebo-kontrollierte, parallele Gruppenstudie mit einer offenen Verlängerung konzipiert. Interessierte Teilnehmer können über die Investor Relations-Website des Unternehmens auf die Live-Telefonkonferenz und den Webcast zugreifen, wobei anschließend eine archivierte Version zur Verfügung gestellt wird.
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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
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