Lexicon Announces Completion of Screening in Phase 2B Progress Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)
Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced the completion of screening for its Phase 2B PROGRESS study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP). The company expects to complete enrollment ahead of schedule, with top-line data now anticipated in Q1 2025, earlier than the previously expected Q2 2025.
LX9211, an orally-delivered, potent, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP. The PROGRESS study, which began in December 2023, aims to enroll adult patients with moderate to severe DPNP, allowing them to continue their current pain therapy. The primary endpoint is a reduction of Average Daily Pain Score (ADPS) at 8 weeks.
Lexicon Pharmaceuticals (Nasdaq: LXRX) ha annunciato il completamento dello screening per il suo studio di Fase 2B PROGRESS riguardante LX9211 nel dolore neuropatico periferico diabetico (DPNP). L'azienda prevede di completare l'arruolamento in anticipo rispetto al programma, con dati preliminari ora attesi nel primo trimestre del 2025, prima rispetto al secondo trimestre del 2025 precedentemente previsto.
LX9211, un inibitore potente e selettivo di piccole molecole investigational da somministrare per via orale dell'adaptor-associated kinase 1 (AAK1), ha precedentemente ricevuto la designazione Fast Track dalla Food and Drug Administration (FDA) degli Stati Uniti per il DPNP. Lo studio PROGRESS, iniziato a dicembre 2023, mira ad arruolare pazienti adulti con DPNP da moderata a severa, consentendo loro di continuare la terapia per il dolore attuale. L'obiettivo primario è la riduzione del punteggio medio giornaliero del dolore (ADPS) a 8 settimane.
Lexicon Pharmaceuticals (Nasdaq: LXRX) ha anunciado la finalización del cribado para su estudio de Fase 2B PROGRESS de LX9211 en dolor neuropático periférico diabético (DPNP). La compañía espera completar el reclutamiento antes de lo previsto, con datos preliminares ahora anticipados para el primer trimestre de 2025, antes de lo que se esperaba anteriormente para el segundo trimestre de 2025.
LX9211, un potente e inhibidor selectivo de pequeñas moléculas investigacionales administrado por vía oral de la quinasa asociada a adaptadores 1 (AAK1), ha recibido previamente la designación de Fast Track de la Administración de Alimentos y Medicamentos (FDA) de EE. UU. para el DPNP. El estudio PROGRESS, que comenzó en diciembre de 2023, tiene como objetivo reclutar pacientes adultos con DPNP moderada a grave, permitiéndoles continuar su terapia actual para el dolor. El objetivo primario es una reducción en la puntuación media diaria de dolor (ADPS) a 8 semanas.
Lexicon Pharmaceuticals (Nasdaq: LXRX)는 당뇨병성 말초 신경병( DPNP )에 대한 LX9211의 2B상 PROGRESS 연구의 선별 완료를 발표했습니다. 회사는 예정보다 빠르게 등록을 마칠 것으로 기대하고 있으며, 초기 결과는 이제 2025년 1분기로 예상됩니다, 이는 이전에 예상했던 2025년 2분기보다 빠릅니다.
LX9211은 경구 투여되는 강력하고 선택적인 조사 중인 소분자 AAK1(어댑터 결합 키나제 1)의 억제제로, 이전에 DPNP에 대해 미국 식품의약국(FDA)으로부터 신속 심사 대상으로 지정받았습니다. 2023년 12월에 시작된 PROGRESS 연구는 중등도에서 중증의 DPNP를 가진 성인 환자를 등록하는 것을 목표로 하며, 현재의 통증 치료를 계속할 수 있게 해줍니다. 주요 목표는 8주 후의 평균 일일 통증 점수(ADPS)를 낮추는 것입니다.
Lexicon Pharmaceuticals (Nasdaq: LXRX) a annoncé l'achèvement du dépistage de son étude de phase 2B PROGRESS concernant LX9211 pour la douleur neuropathique périphérique diabétique (DPNP). La société s'attend à terminer l'inscription en avance, avec des données préliminaires désormais attendues au premier trimestre 2025, plus tôt que le deuxième trimestre 2025 initialement prévu.
LX9211, un inhibiteur puissant et sélectif de petites molécules à administrer par voie orale de la kinase associée à l'adaptateur 1 (AAK1), a déjà reçu de la part de la Food and Drug Administration (FDA) des États-Unis la désignation Fast Track pour le DPNP. L'étude PROGRESS, qui a commencé en décembre 2023, vise à recruter des patients adultes atteints de DPNP modéré à sévère, leur permettant de continuer leur traitement anti-douleur actuel. L'objectif principal est une réduction de la note moyenne quotidienne de douleur (ADPS) à 8 semaines.
Lexicon Pharmaceuticals (Nasdaq: LXRX) hat den Abschluss des Screenings für die Phase 2B PROGRESS-Studie zu LX9211 bei diabetischer peripherer Neuropathieschmerzen (DPNP) bekannt gegeben. Das Unternehmen erwartet, dass die Einschreibung vorzeitig abgeschlossen wird, mit Ergebnissen, die nun im ersten Quartal 2025 erwartet werden, früher als ursprünglich für das zweite Quartal 2025 vorgesehen.
LX9211, ein oral verabreichter, potenter, selektiver, experimenteller kleiner Molekülinhibitor der adapterassoziierten Kinase 1 (AAK1), erhielt zuvor von der US-amerikanischen Food and Drug Administration (FDA) die Fast Track-Diagnose für DPNP. Die PROGRESS-Studie, die im Dezember 2023 begann, zielt darauf ab, erwachsene Patienten mit mäßigem bis starkem DPNP zu rekrutieren, damit sie ihrer aktuellen Schmerztherapie weiterhin nachgehen können. Das Hauptziel ist eine Verringerung des Durchschnittlichen Täglichen Schmerzscores (ADPS) nach 8 Wochen.
- Completion of screening for Phase 2B PROGRESS study ahead of schedule
- Anticipated top-line data moved forward to Q1 2025 from Q2 2025
- LX9211 has received Fast Track designation from FDA for DPNP
- None.
Insights
The completion of screening for the Phase 2B PROGRESS study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP) is a significant milestone for Lexicon Pharmaceuticals. This development, coupled with the accelerated timeline for top-line data, now expected in Q1 2025, could potentially catalyze investor interest.
Key points to consider:
- LX9211's Fast Track designation from the FDA underscores the drug's potential to address an unmet medical need
- The lack of new non-opioid medications for neuropathic pain in over two decades highlights a substantial market opportunity
- Accelerated enrollment suggests strong interest from both patients and clinicians, which could bode well for future adoption if approved
However, investors should note that Phase 2B results, while important, are not definitive. The primary endpoint of reducing Average Daily Pain Score at 8 weeks will be important in determining the drug's efficacy and potential for further development.
From a financial perspective, this news presents a positive outlook for Lexicon Pharmaceuticals. The accelerated timeline could lead to:
- Reduced R&D costs associated with a shorter trial duration
- Earlier potential revenue streams if LX9211 proves successful and moves to Phase 3 trials
- Increased investor confidence, potentially impacting stock valuation positively
With a market cap of
- Phase 2B success doesn't guarantee Phase 3 or FDA approval
- The company's cash runway and ability to fund further development will be critical factors to monitor
- Potential partnerships or licensing deals could emerge as the drug progresses, impacting future revenue sharing
Investors should weigh this positive development against the overall risk profile of biotech investments and Lexicon's pipeline diversity.
Top-line Data Now Anticipated in Q1 2025
LX9211 has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP
THE WOODLANDS, Texas, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has closed screening and expects to complete enrollment ahead of schedule in PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS with Diabetic Peripheral Neuropathic Pain) studying LX9211, an orally-delivered, potent, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). The Company also updated its expectations for the timing of anticipated top-line data, from the second quarter of 2025 to the first quarter of 2025.
“We are excited to be ahead of schedule for a near-term completion of PROGRESS for LX9211, with top-line data now anticipated in Q1 of next year,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “There have been no new, non-opioid medications approved for neuropathic pain in more than two decades, and there is an urgent need for novel treatment options. We believe that LX9211 has the potential to positively impact the lives of people suffering with neuropathic pain and we thank the investigators, study sites, Lexicon clinical team members and especially the patients for their participation in this important 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, with patients allowed to continue their current pain therapy. The primary endpoint of PROGRESS is a reduction of Average Daily Pain Score (ADPS) at 8 weeks.
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 commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
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 diabetic peripheral neuropathic pain.
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 LX9211 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, 2023, 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
FAQ
What is the current status of Lexicon's PROGRESS study for LX9211 in DPNP?
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