New Analysis of Phase 3 Data Demonstrating Renal Protective Benefits of Sotagliflozin to be Presented at ASN Kidney Week 2024
Lexicon Pharmaceuticals announced a new analysis of its Phase 3 SCORED clinical trial demonstrating sotagliflozin's protective effects in patients with diabetic kidney disease (DKD). The post hoc analysis evaluated sotagliflozin's effect on Estimated Glomerular Filtration Rate (eGFR) slope versus placebo. Results showed a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year across 10,574 participants. Notably, sotagliflozin demonstrated greater benefit on chronic slope with increasing baseline albuminuria. The findings will be presented at Kidney Week 2024 in San Diego.
Lexicon Pharmaceuticals ha annunciato una nuova analisi del suo trial clinico di Fase 3 SCORED che dimostra gli effetti protettivi del sotagliflozin nei pazienti con malattia renale diabetica (DKD). L'analisi post hoc ha valutato l'effetto del sotagliflozin sulla pendenza della Velocità di Filtrazione Glomerulare Stimata (eGFR) rispetto al placebo. I risultati hanno mostrato un calo acuto dell'eGFR, corretto per il placebo, di -2,59 ml/min/1.73m2/anno su un totale di 10.574 partecipanti. È importante notare che il sotagliflozin ha dimostrato un beneficio maggiore sulla pendenza cronica con un aumento dell'albuminuria di base. I risultati saranno presentati alla Kidney Week 2024 a San Diego.
Lexicon Pharmaceuticals anunció un nuevo análisis de su ensayo clínico de Fase 3 SCORED que demuestra los efectos protectores del sotagliflozina en pacientes con enfermedad renal diabética (DKD). El análisis post hoc evaluó el efecto de la sotagliflozina en la pendiente de la Tasa de Filtración Glomerular Estimada (eGFR) en comparación con el placebo. Los resultados mostraron una disminución aguda ajustada por placebo en la eGFR de -2.59 ml/min/1.73m2/año entre 10,574 participantes. Cabe destacar que la sotagliflozina demostró un beneficio mayor en la pendiente crónica con un aumento de la albuminuria basal. Los hallazgos se presentarán en la Kidney Week 2024 en San Diego.
Lexicon Pharmaceuticals는 당뇨병성 신장 질환(DKD) 환자에서 소탁글리플로진의 보호 효과를 보여주는 임상 시험 3상 SCORED의 새로운 분석을 발표했습니다. 사후 분석에서는 소탁글리플로진의 추정 사구체 여과율(eGFR) 경향에 대한 영향을 위약군과 비교하였습니다. 결과는 10,574명의 참가자를 대상으로 한 eGFR의 위약 조정 급성 감소가 -2.59 ml/min/1.73m2/년이라는 것을 보여주었습니다. 특히, 소탁글리플로진은 기저 알부민뇨가 증가함에 따라 만성 경향에서 더 큰 이점을 나타냈습니다. 연구 결과는 2024년 샌디에고에서 열리는 Kidney Week에서 발표될 예정입니다.
Lexicon Pharmaceuticals a annoncé une nouvelle analyse de son essai clinique de Phase 3 SCORED démontrant les effets protecteurs du sotagliflozin chez les patients atteints de maladie rénale diabétique (DKD). L'analyse post hoc a évalué l'effet du sotagliflozin sur la pente du Taux de Filtration Glomérulaire Estimé (eGFR) par rapport au placebo. Les résultats ont montré un déclin aigu ajusté au placebo de l'eGFR de -2,59 ml/min/1,73m2/an chez 10 574 participants. Il est à noter que le sotagliflozin a démontré un bénéfice accru sur la pente chronique avec une augmentation de l'albuminurie de base. Les résultats seront présentés lors de la Kidney Week 2024 à San Diego.
Lexicon Pharmaceuticals hat eine neue Analyse seiner Phase-3-Studie SCORED angekündigt, die die schützenden Effekte von Sotagliflozin bei Patienten mit diabetischer Nierenerkrankung (DKD) demonstriert. Die post hoc Analyse bewertete die Wirkung von Sotagliflozin auf die Neigung der Geschätzten Glomerulären Filtrationsrate (eGFR) im Vergleich zur Placebo-Gruppe. Die Ergebnisse zeigten einen placebokorrigierten akuten Rückgang der eGFR um -2,59 ml/min/1,73m2/Jahr bei 10.574 Teilnehmern. Bemerkenswert ist, dass Sotagliflozin bei zunehmender Ausgangsalbuminurie einen größeren Nutzen auf der chronischen Neigung zeigte. Die Ergebnisse werden auf der Kidney Week 2024 in San Diego präsentiert.
- Phase 3 SCORED trial demonstrated protective effects in diabetic kidney disease patients
- Study showed significant results across 10,574 participants
- Greater benefits observed with increasing baseline albuminuria
- Placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year
Insights
The post-hoc analysis of the Phase 3 SCORED trial reveals significant insights about sotagliflozin's renal protective effects. The data shows an initial acute eGFR decline of
The most notable finding is the enhanced benefit on chronic slope in patients with higher baseline albuminuria, indicating stronger protective effects in those with more severe kidney disease. This positions sotagliflozin competitively in the DKD treatment landscape alongside established SGLT2 inhibitors like dapagliflozin and empagliflozin.
The dual SGLT1 and 2 inhibition mechanism could potentially offer broader therapeutic benefits compared to selective SGLT2 inhibitors, though head-to-head comparisons would be needed to confirm this hypothesis.
Post hoc analysis evaluated sotagliflozin in patients with diabetic kidney disease (DKD)
THE WOODLANDS, Texas, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a new analysis of its Phase 3 SCORED clinical trial demonstrating the protective effects of sotagliflozin in patients with diabetic kidney disease (DKD). Data will be presented at Kidney Week 2024, the annual meeting of the American Society of Nephrology in San Diego, California.
Previous analyses of the SCORED trial have shown that sotagliflozin, a dual SGLT1 & 2 inhibitor, reduced the risk of kidney and cardiorenal composite endpoints in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). The objective of this new post hoc analysis of SCORED was to evaluate the effect of sotagliflozin versus placebo on Estimated Glomerular Filtration Rate (eGFR) slope, and the impact of baseline kidney function and glycemia. The eGFR slope assessment is widely used as a surrogate endpoint in cardiovascular and chronic kidney disease trials.
Details for the presentation are as follows:
- “Effect of sotagliflozin on eGFR slope by baseline kidney function and glycemic control” – a moderated poster presentation, Friday, October 25, 10:00a.m.PT, 4:00-5:00p.m, Exhibit Hall, San Diego Convention Center, presented by Vikas S. Sridhar, M.D., University of Toronto, Ontario
Within the entire cohort of 10,574 participants, a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year (
“Researchers observed positive renal protection with sotagliflozin across a spectrum of baseline kidney function and glycemic control. This study makes an important contribution to understanding the clinical benefits of sotagliflozin for people with diabetic kidney disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.
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 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.
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, 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
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