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Lexicon to Present Data at the 85th Scientific Sessions of the American Diabetes Association (ADA)

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Lexicon Pharmaceuticals (LXRX) will present clinical data at the 85th ADA Scientific Sessions on June 20-23, 2025, in Chicago. The presentation focuses on sotagliflozin's ability to reduce hypoglycemic events in type 1 diabetes patients across different kidney function levels, categorized by eGFR ranges. Dr. M. Belinda Hardin will deliver an oral presentation on June 22 discussing these findings. Additionally, Lexicon will present topline results from their PROGRESS Phase 2b study of pilavapadin (LX9211), evaluating its effectiveness in treating diabetic peripheral neuropathic pain. The presentations align with ADA's 2025 Standards of Care emphasis on preventing hypoglycemia in type 1 diabetes management.
Lexicon Pharmaceuticals (LXRX) presenterà dati clinici durante la 85ª sessione scientifica ADA dal 20 al 23 giugno 2025 a Chicago. La presentazione si concentrerà sulla capacità del sotagliflozin di ridurre gli eventi ipoglicemici nei pazienti con diabete di tipo 1, suddivisi in base ai diversi livelli di funzione renale, categorizzati secondo le gamme di eGFR. La dottoressa M. Belinda Hardin terrà una presentazione orale il 22 giugno per discutere questi risultati. Inoltre, Lexicon presenterà i risultati preliminari dello studio PROGRESS di fase 2b sul pilavapadin (LX9211), valutandone l'efficacia nel trattamento del dolore neuropatico periferico diabetico. Le presentazioni sono in linea con l'enfasi degli Standard di Cura ADA 2025 sulla prevenzione dell'ipoglicemia nella gestione del diabete di tipo 1.
Lexicon Pharmaceuticals (LXRX) presentará datos clínicos en las 85ª Sesiones Científicas de la ADA del 20 al 23 de junio de 2025 en Chicago. La presentación se centrará en la capacidad de sotagliflozina para reducir los eventos hipoglucémicos en pacientes con diabetes tipo 1, clasificados según diferentes niveles de función renal, categorizados por rangos de eGFR. La Dra. M. Belinda Hardin ofrecerá una presentación oral el 22 de junio para discutir estos hallazgos. Además, Lexicon presentará los resultados principales de su estudio PROGRESS de fase 2b sobre pilavapadina (LX9211), evaluando su efectividad en el tratamiento del dolor neuropático periférico diabético. Las presentaciones están alineadas con el énfasis de los Estándares de Atención ADA 2025 en la prevención de la hipoglucemia en el manejo de la diabetes tipo 1.
Lexicon Pharmaceuticals(LXRX)는 2025년 6월 20일부터 23일까지 시카고에서 열리는 제85회 ADA 과학 세션에서 임상 데이터를 발표할 예정입니다. 발표는 사구체 여과율(eGFR) 범위별로 분류된 다양한 신장 기능 수준에 따른 제1형 당뇨병 환자의 저혈당 사건 감소에 대한 sotagliflozin의 효과에 중점을 둡니다. M. Belinda Hardin 박사가 6월 22일 구두 발표를 통해 이 결과를 논의할 예정입니다. 또한 Lexicon은 당뇨병성 말초 신경병증성 통증 치료 효과를 평가하는 PROGRESS 2b상 연구인 pilavapadin(LX9211)의 주요 결과도 발표할 것입니다. 이 발표들은 제1형 당뇨병 관리에서 저혈당 예방에 중점을 둔 ADA 2025 치료 표준과 일치합니다.
Lexicon Pharmaceuticals (LXRX) présentera des données cliniques lors des 85èmes sessions scientifiques de l'ADA du 20 au 23 juin 2025 à Chicago. La présentation portera sur la capacité du sotagliflozine à réduire les événements hypoglycémiques chez les patients atteints de diabète de type 1, répartis selon différents niveaux de fonction rénale, catégorisés par plages de DFG estimé (eGFR). Le Dr M. Belinda Hardin fera une présentation orale le 22 juin pour discuter de ces résultats. De plus, Lexicon présentera les résultats principaux de leur étude PROGRESS de phase 2b sur le pilavapadin (LX9211), évaluant son efficacité dans le traitement de la douleur neuropathique périphérique diabétique. Ces présentations s'alignent avec l'accent mis par les Standards de soins ADA 2025 sur la prévention de l'hypoglycémie dans la prise en charge du diabète de type 1.
Lexicon Pharmaceuticals (LXRX) wird klinische Daten auf den 85. ADA Scientific Sessions vom 20. bis 23. Juni 2025 in Chicago präsentieren. Die Präsentation konzentriert sich auf die Fähigkeit von Sotagliflozin, hypoglykämische Ereignisse bei Patienten mit Typ-1-Diabetes über verschiedene Nierenfunktionsstufen, kategorisiert nach eGFR-Bereichen, zu reduzieren. Dr. M. Belinda Hardin wird am 22. Juni eine mündliche Präsentation zu diesen Ergebnissen halten. Zusätzlich wird Lexicon die Hauptergebnisse ihrer PROGRESS Phase-2b-Studie zu Pilavapadin (LX9211) vorstellen, in der die Wirksamkeit bei der Behandlung diabetischer peripherer neuropathischer Schmerzen untersucht wird. Die Präsentationen entsprechen dem Schwerpunkt der ADA 2025 Versorgungsstandards zur Vermeidung von Hypoglykämien im Management von Typ-1-Diabetes.
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Oral presentation on study demonstrating the ability of sotagliflozin to reduce the risk of hypoglycemic events regardless of kidney function in people with type 1 diabetes

THE WOODLANDS, Texas, June 18, 2025 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from a study evaluating the impact of sotagliflozin on hypoglycemia in people with type 1 diabetes will be delivered as an oral presentation on Sunday, June 22, during the 85th Scientific Sessions of the American Diabetes Association (ADA). At the meeting, the company will also present topline data from its PROGRESS Phase 2b study evaluating pilavapadin (LX9211) in adults with diabetic peripheral neuropathic pain. The congress is being held June 20–23, 2025 at the McCormick Place Convention Center in Chicago, Illinois.

The ADA recently emphasized that hypoglycemia remains an important patient management issue in type 1 diabetes. Its Standards of Care in Diabetes -- 2025 clinical update states, “Health care professionals should be vigilant in preventing hypoglycemia.”

In a session entitled “Interventions to Prevent Hypoglycemia: Bench to Bedside,” Lexicon US Medical Affairs team member M. Belinda Hardin, PharmD, BCPS, will present sotagliflozin clinical efficacy data segmented by three common kidney-function subgroups: Estimated Glomerular Filtration Rate (eGFR) of < 60 ml/min/1.73m2, ≥ 60 to < 90 ml/min/1.73m2, and ≥ 90 ml/min/1.73m2.

“We appreciate the opportunity to share our study results in an oral presentation at this important gathering of the diabetes community,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We anticipate lively discussions following Dr. Hardin’s presentation and throughout the ‘Interventions to Prevent Hypoglycemia’ session.”

Presentation details:

  • “Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function” -- Sunday, June 22, 4:00-4:15 p.m. CT, Presentation 244-OR, W181 A-C, presented by M. Belinda Hardin, PharmD, BCPS, US Medical Affairs, Lexicon Pharmaceuticals, Inc. on behalf of the inTandem study investigators

During the 85th Scientific Sessions, Lexicon also will present topline data from its PROGRESS Phase 2b study evaluating pilavapadin (LX9211) in adults with diabetic peripheral neuropathic pain.

Presentation details:

  • “Pilavapadin, an Oral, Non-opioid, AAK1 Inhibitor for Diabetic Peripheral Neuropathic Pain (DPNP)--Results from a Phase 2b, Dose-Ranging, Randomized, Multicenter Study” -- Sunday, June 22, 12:30-1:30 p.m. CT, Board No. 1876, Poster Hall F1

About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

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 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 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 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 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 


FAQ

When is Lexicon Pharmaceuticals presenting at the ADA Scientific Sessions 2025?

Lexicon will present on Sunday, June 22, 2025, with sotagliflozin data presented at 4:00-4:15 PM CT and pilavapadin data presented at 12:30-1:30 PM CT.

What will LXRX present about sotagliflozin at the ADA conference?

Lexicon will present data showing sotagliflozin's ability to reduce hypoglycemic events in type 1 diabetes patients across different kidney function levels, categorized by eGFR ranges.

What is the PROGRESS Phase 2b study that Lexicon will present at ADA 2025?

The PROGRESS Phase 2b study evaluates pilavapadin (LX9211), an oral, non-opioid AAK1 inhibitor, for treating diabetic peripheral neuropathic pain.

Where will the 85th ADA Scientific Sessions be held?

The 85th ADA Scientific Sessions will be held at the McCormick Place Convention Center in Chicago, Illinois, from June 20-23, 2025.
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