Data on Early Clinical Benefit for INPEFA® (Sotagliflozin) Will Be Among Five Lexicon-Sponsored Presentations at the American Heart Association Scientific Sessions 2023
Data on Early Clinical Benefit for INPEFA® (Sotagliflozin) Will Be Among Five Lexicon-Sponsored Presentations at the American Heart Association Scientific Sessions 2023
Cost-effectiveness data and analyses of financial impact among patients hospitalized for heart failure and treated with INPEFA included as important data selected for presentation
THE WOODLANDS, Texas, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that five data presentations related to INPEFA® (sotagliflozin) will be delivered during the American Heart Association Scientific Sessions 2023, November 11-13, 2023, at the Pennsylvania Convention Center in Philadelphia, PA.
Two of the data sets have been selected for oral presentations; one highlighting the early clinical benefit of INPEFA for heart failure and atherosclerotic events, the other focusing on cost-effectiveness metrics associated with the use of INPEFA.
“Our significant upcoming presence at the American Heart Association Scientific Sessions 2023 reflects the dedication of investigators to expanding the scientific evidence available to clinicians and payers as they make decisions around how to best utilize available treatment options in patients,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We look forward to engaging with attendees and continuing to demonstrate both the clinical and economic value of INPEFA.”
Details of the presentations are as follows:
Sotagliflozin is associated with early clinical benefit for heart failure and atherosclerotic events – an oral presentation, Sunday, November 12, 2:10 - 2:15 p.m. ET, Zone 2‚ Science and Technology Hall‚ Level 2, presented by Rahul Aggarwal, M.D., Brigham and Women’s Hospital, Boston, MA
Cost-effectiveness of sotagliflozin in heart failure patients with preserved and reduced ejection fractions—results from SOLOIST-WHF – an oral presentation, Sunday, November 12, 12:10 - 12:15 p.m. ET, Zone 2‚ Science and Technology Hall‚ Level 2, presented by William Weintraub, M.D., Medstar Washington Hospital Center, Washington, DC
How will the use of new heart failure treatments impact US health system reimbursement under alternative payment models: Measuring the impact of sotagliflozin use among patients hospitalized for heart failure – an ePoster, Sunday, November 12, 11:30 a.m. - 12:45 p.m. ET, Board #2122, presented by Slaven Sikirica, M.Sc., Lexicon Pharmaceuticals
Sotagliflozin, a dual SGLT 1 and 2 Inhibitor, has high membrane affinity and hydrocarbon core location compared with empagliflozin – an ePoster, Sunday, November 12, 3:30 - 3:45 p.m. ET, Board #2222, presented by Preston Mason, M.D., Brigham and Women’s Hospital, Boston, MA
Relationship between left ventricular ejection fraction and ICD-10 codes among patients hospitalized with heart failure – a poster presentation, Saturday, November 11, 3:00 - 4:15 p.m. ET, Board #2305, presented by Tyler Gluckman, M.D., FACC, Center for Cardiovascular Analytics, Research, and Data Science, Providence Heart Institute, Portland, OR
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, 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 diseases safely and effectively. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
Discovered using Lexicon’s unique approach to gene science, INPEFA® (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 reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. INPEFA has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
INDICATION
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.
Contraindications: INPEFA is contraindicated in patients with hypersensitivity to any component.
Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.
Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.
Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.
Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.
Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.
Use in Specific Populations:
Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.
Geriatric Use: No INPEFA dosage change is recommended based on age. No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.
Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m2) and in patients with heart failure with eGFR 2. The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile. There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR 2 relative to the overall safety population. Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis. After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis.
Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment.
Click here for full Prescribing Information.
About the SOLOIST-WHF Study
SOLOIST-WHF was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SOLOIST-WHF achieved its primary endpoint, with overall tolerability similar to placebo. Results were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in an article titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” which may be accessed at www.nejm.org.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of INPEFA® (sotagliflozin). In addition, this press release also contains forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development 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 INPEFA in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of INPEFA (in other indications), LX9211 and 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 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, 2022 and other subsequent disclosure documents 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.
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