SGLT

JDRF Awards $9 Million US for Phase 3 Type 1 Diabetes Kidney Disease Clinical Trial, Joins The Kidney Foundation of Canada in Driving Research to Treat Kidney Disease

Retrieved on: 
Monday, January 22, 2024
Diabetes, Patient, Research, Diabetic nephropathy, Kidney, Kidney failure, Person, T1D, CIHR, SGLT2, Team, University, Kidney disease, Joslin Diabetes Center, Risk, KFOC, Type 2 diabetes, Safety, Public, University of Toronto, SGLT, JDRF, Clinical trial, University Health Network, Pharmaceutical industry

Kidney disease remains a life-threatening complication for those living with diabetes.

Key Points: 
  • Kidney disease remains a life-threatening complication for those living with diabetes.
  • Almost half of kidney failure cases are caused by diabetes, and an estimated one out of three people with T1D develop significant kidney disease.
  • SUGARNSALT is one of the largest T1D focused kidney disease studies in the world, and it is the only phase 3 clinical trial targeting major kidney disease outcomes.
  • "The Kidney Foundation of Canada is proud to be one of the founding partners on this significant investment to support innovative strategies to treat diabetic kidney disease.

Sirona Biochem Corporate Update January 2024

Retrieved on: 
Wednesday, January 24, 2024
IP, Cellulite, Communication, OTC, TSX, Allergan, Sirona, Safety, Intellectual property, SGLT, Ageing, Cosmeceutical, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona”) provides the following update:

Key Points: 
  • VANCOUVER, British Columbia, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona”) provides the following update:
    We are pleased to provide an update on our recent milestones and strategic decisions shaping Sirona Biochem's path forward.
  • Sirona Biochem will maintain majority ownership in the subsidiary.
  • Envisioning beyond a single product, Sirona Biochem sees a future of diversified offerings with multiple products utilizing GlycoProteMim.
  • By pursuing a quicker route to profitability, we reduce reliance on recurrent financing, ensuring stability and a sustainable growth trajectory for Sirona Biochem and its subsidiaries.

Data on Early Clinical Benefit for INPEFA® (Sotagliflozin) Will Be Among Five Lexicon-Sponsored Presentations at the American Heart Association Scientific Sessions 2023

Retrieved on: 
Thursday, November 2, 2023
MA, Food, SGLT, Lexicon Pharmaceuticals, FACC, American Heart Association, Regulation of tobacco by the U.S. Food and Drug Administration, Sotagliflozin, Risk, Hospital, Pennsylvania Convention Center, Patient, Heart failure, MedStar Washington Hospital Center, Data science, Pharmaceutical industry, Research, Brigham

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.

Key Points: 
  • “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, 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.

Published Analysis of Sotagliflozin (INPEFA(TM)) Clinical Data Demonstrates Significant Reductions in the Risk of Hospital Readmissions for Heart Failure

Retrieved on: 
Tuesday, August 8, 2023
University, Heart failure, Journal of the American College of Cardiology, HF, FACC, Research, Mortality, Patient, School, Post hoc analysis, American College, Caregiver, FDA, SGLT, Regulation of tobacco by the U.S. Food and Drug Administration, Food, JACC, Pharmaceutical industry, Journal

THE WOODLANDS, Texas, Aug. 08, 2023 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post hoc analysis of data from the SOLOIST-WHF Phase 3 outcomes study of sotagliflozin has been published by the Journal of the American College of Cardiology (JACC): Heart Failure. The U.S. Food and Drug Administration (FDA) approved sotagliflozin under the brand name INPEFATM for treatment of heart failure (HF) on May 26, 2023.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) approved sotagliflozin under the brand name INPEFA TM for treatment of heart failure (HF) on May 26, 2023.
  • Of the 1,222 randomized patients participating in the SOLOIST-WHF study, 596 received sotagliflozin on or before their date of discharge.
  • Treatment with sotagliflozin resulted in significant relative risk reductions of approximately 50% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at 30- or 90-days following hospital discharge versus placebo.
  • The results emphasize the importance of beginning SGLT inhibition before discharge.”
    “We are grateful to the SOLOIST-WHF investigators for conducting this important analysis.

JDRF Joins Diabetes Professionals at the American Diabetes Association 83rd Scientific Sessions to Celebrate Advancements in Type 1 Diabetes Research

Retrieved on: 
Monday, June 26, 2023
Injection, JDRF, San Diego Convention Center, Insulin, Sessions, Diabetes, T1D, Vertex, Clinical trial, Research, DKA, Melton, American Diabetes Association, Vertex Pharmaceuticals, ADA, SGLT, Disease, Pharmaceutical industry

JDRF-supported research has been highlighted at the annual event since JDRF started funding research nearly 50 years ago.

Key Points: 
  • JDRF-supported research has been highlighted at the annual event since JDRF started funding research nearly 50 years ago.
  • "JDRF looks forward to the ADA Scientific Sessions each year for the opportunity to come together as a community, learn from one another, and showcase the innovation and progress across the spectrum of diabetes research.
  • For decades, JDRF's leadership in driving type 1 diabetes research has been featured at the Sessions," said Aaron Kowalski, Ph.D., JDRF CEO.
  • "The research presented at the ADA Scientific Sessions demonstrates the incredible momentum that is accelerating breakthroughs to find cures, prevent the disease, and treat type 1 diabetes and its complications.

Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure

Retrieved on: 
Thursday, June 15, 2023
Contraindication, ACC, SGLT1, Heart failure, Chronic kidney disease, Diabetes, Hospital, American Heart Association, Guideline, LVEF, Management of heart failure, SGLT2, AHA, Heart Failure Society of America, GDMT, Conference call, Patient, Risk, Type, Heart, American College, Lexicon Pharmaceuticals, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, SGLT, Conference, Food, Pharmaceutical industry, Dietary supplement, Heart failure with preserved ejection fraction, Webcast

THE WOODLANDS, Texas, May 26, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

Key Points: 
  • The broad label encompasses heart failure patients across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes.
  • “We expect this important innovation to be commercially available in the U.S. market by the end of June 2023.”
    The approval is based on two randomized, double-blind, placebo-controlled Phase 3 cardiovascular outcomes studies of INPEFA in patients with heart failure or at risk of heart failure.
  • Results from SOLOIST-WHF showed that INPEFA significantly reduced risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to placebo in patients who had been recently hospitalized for worsening heart failure.
  • The SGLT inhibitor class was recommended as first-line treatment for heart failure by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in their joint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

Lexicon Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 2, 2023
Heart failure, NDA, Postherpetic neuralgia, Congress, PHN, Risk, Neuropathic pain, PDUFA, American College, Lexicon Pharmaceuticals, FDA, SGLT, DPN, Pharmaceutical industry, Cardiology

THE WOODLANDS, Texas, May 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2023 and provided an update on key corporate milestones.

Key Points: 
  • NDA for Sotagliflozin on Track for May 27th, 2023 PDUFA date
    THE WOODLANDS, Texas, May 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2023 and provided an update on key corporate milestones.
  • For the first quarters of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $3.4 million and $2.8 million, respectively.
  • Cash and Investments: As of March 31, 2023, Lexicon had $105.9 million in cash and investments, as compared to $138.4 million as of December 31, 2022.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Lexicon Pharmaceuticals Reports Fourth Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 2, 2023
PHN, American Heart Association, FDA, UACR, SGLT1, NDA, Albuminuria, Poster, Society, Treatment, Science, DPN, Heart failure, Patient, Pharmacokinetics, Efficacy, PDUFA, Congress, Therapy, SGLT, Neuropathic pain, Mortality, American College, Postherpetic neuralgia, Pharmaceutical industry, Cardiology, Safety

THE WOODLANDS, Texas, March 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones.

Key Points: 
  • THE WOODLANDS, Texas, March 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones.
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2022 compared to the fourth quarter and full year of 2021.
  • For the fourth quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $3.3 million and $2.2 million, respectively.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Readout Health Biosense device to be tested in JDRF-funded clinical trial in people with Type 1 Diabetes using SGLT inhibitors at Washington University

Retrieved on: 
Tuesday, July 12, 2022
Technology, American Diabetes Association, Clinical trial, Safety, Health, Diabetic ketoacidosis, Multimedia, Ketoacidosis, Volunteering, Washington University School of Medicine, Risk, Patient, Doctor of Philosophy, Review, George Washington University School of Medicine & Health Sciences, MD, Lists of diseases, Insulin, Heart failure, Degenerative disease, Ketone, Chronic kidney disease, T2D, Kidney disease, SGLT, FDA, Ketosis, Person, Exercise, Obesity, DKA, Efficiency, Industry, JDRF, Medical device, Pharmaceutical industry, T1D, Research, BioSense, St. Louis

ST. LOUIS, July 12, 2022 /PRNewswire/ -- Readout Health, a medical digital health startup, announces a sponsored research agreement with Washington University School of Medicine in St. Louis that received a $360,000 research grant from JDRF. The two-year grant is aimed at testing the efficacy of the Biosense® handheld breath ketone monitor in persons with type 1 diabetes (T1D) during usual care with insulin and with the addition of a sodium glucose transporter inhibitor (SGLT2i) drug. Janet McGill, MD, a professor at Washington University School of Medicine and the recipient of the American Diabetes Association's 2022 Outstanding Physician Clinician award, will serve as the principal investigator.

Key Points: 
  • $360,000 grant to review safety and accuracy of Biosense device aimed at DKA risk mitigation in patients using SGLTi drug class.
  • ST. LOUIS, July 12, 2022 /PRNewswire/ -- Readout Health, a medical digital health startup, announces a sponsored research agreement with Washington University School of Medicine in St. Louis that received a $360,000 research grant from JDRF.
  • Janet McGill, MD, a professor at Washington University School of Medicine and the recipient of the American Diabetes Association's 2022 Outstanding Physician Clinician award,will serve as the principal investigator.
  • Development of ketone monitoring technologies like Biosense are a critical part of the strategy to enable safe, effective use of SGLT inhibitors in type 1 diabetes."

Abbott Announces Development of Novel Continuous Glucose-Ketone Monitoring System

Retrieved on: 
Friday, June 3, 2022
Consensus, Ketoacidosis, Kidney, Hospital, Life, Continuous glucose monitor, Prenatal nutrition, Diabetic ketoacidosis, DKA, Food, JDRF, CGM, Interpretation, Blood, Part, FreeStyle, Utility, Method, Journal of Diabetes Science and Technology, Risk, Review, Technology, Clinical case definition, NYSE, Pivotal, Adoption, Incidence, Diagnosis, Ketone, Heart, SGLT, CKM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Integration, Glucose, Medical device, Pharmaceutical industry, Frankincense, Fine chemical, Diabetes, Patient

"We're designing our glucose-ketone monitoring system with superior sensing technology that will pair with industry-leading insulin pumps to create a best-in-class solution.

Key Points: 
  • "We're designing our glucose-ketone monitoring system with superior sensing technology that will pair with industry-leading insulin pumps to create a best-in-class solution.
  • Recent studies show continuous ketone monitoring (CKM) could help prevent DKA.3 With continuous monitoring, rising ketone levels can be detected early, as a warning of impending ketoacidosis, and inform care so that DKA does not develop.
  • Abbott is already conducting clinical studies on the glucose-ketone monitoring system.
  • Abbott plans to partner with leading insulin pump manufacturers to make the dual monitoring system interoperable with insulin delivery systems.