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Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

Retrieved on: 
Monday, April 1, 2024

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, April 1, 2024

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today reported its fourth quarter and full year 2023 financial results and provided a business update.

Key Points: 
  • “In addition, we expect to complete enrollment of our pivotal Revitalize-1 study and are excited to report topline data in the fourth quarter of 2024.
  • The Company expects to complete enrollment in the first half of 2024 and report topline data in the fourth quarter of 2024.
  • In December 2023, Fractyl presented preclinical findings in an oral presentation at the World Congress of Insulin Resistance Diabetes and Cardiovascular Disease 2023 Annual Meeting.
  • Cash Position: As of December 31, 2023, Fractyl had approximately $33.2 million in cash and cash equivalents.

Inventiva announces positive results from the Phase II, LEGEND, Proof-of-Concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and T2D

Retrieved on: 
Monday, March 18, 2024

Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.

Key Points: 
  • Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.
  • The treatment with lanifibranor 800mg/once daily alone or in combination with empagliflozin for 24 weeks was well tolerated, with no safety concerns reported.
  • The trial is double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm.
  • More details on these results are expected to be presented in upcoming scientific conferences and submitted for publication.

 Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Retrieved on: 
Saturday, April 6, 2024

Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia.
  • “These long-term safety results and metabolic outcomes from the EMERGENT program are extremely encouraging, allowing us to further understand the tolerability profile of KarXT in people living with schizophrenia,” said Roland Chen , MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb.
  • In the pooled analysis, KarXT demonstrated a favorable impact on weight and long-term metabolic profile where most patients experienced stability or improvements on key metabolic parameters over 52 weeks of treatment.
  • In the long-term studies, KarXT was generally well-tolerated across 52 weeks of treatment, with a side effect profile consistent with prior trials of KarXT in schizophrenia.

L-Nutra's Groundbreaking Study Revolutionizes Type 2 Diabetes Management Through Fasting Mimicking Nutrition Technology

Retrieved on: 
Thursday, April 4, 2024

This randomized, controlled, assessor-blinded trial introduces a new paradigm in diabetes management, focusing on "glycemic management,'' a new metric used to measure efficacy by medication reduction.

Key Points: 
  • This randomized, controlled, assessor-blinded trial introduces a new paradigm in diabetes management, focusing on "glycemic management,'' a new metric used to measure efficacy by medication reduction.
  • Glycemic Management: FMD participants demonstrated superior glycemic management, with 53% showing improvement, compared to only 8% in the control group.
  • L-Nutra's patented and clinically backed nutrition technology food formulations are effective in supporting metabolism, cell renewal, and muscle protection by mimicking the reset and rejuvenation pathways of fasting.
  • "With the Fasting Mimicking Diet, we have successfully enhanced the natural rejuvenating power of fasting with food which has made the regression and remission of diabetes within every patient's reach.

DRAWBRIDGE SECURES FDA 510(K) CLEARANCE FOR AT-HOME BLOOD SAMPLING DEVICE NANODROP

Retrieved on: 
Tuesday, April 2, 2024

NEW YORK, April 2, 2024 /PRNewswire/ -- Drawbridge Health, a healthcare technology company focused on reinventing the blood draw experience, today announced that its at-home, patented blood sampling device, NanoDrop, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Over-the-Counter use. The clearance of this novel dual nano-lancet technology expands a growing suite of products that already includes the OneDraw Collection System, cleared by the FDA as a Class II medical device to collect blood samples to measure HbA1c for monitoring the long-term control of blood sugar (glucose) in diabetic individuals.

Key Points: 
  • The clearance of this novel dual nano-lancet technology expands a growing suite of products that already includes the OneDraw Collection System, cleared by the FDA as a Class II medical device to collect blood samples to measure HbA1c for monitoring the long-term control of blood sugar (glucose) in diabetic individuals.
  • NanoDrop is a one-of-a-kind, user-friendly lancet that allows individuals to obtain capillary whole-blood samples with a virtually painless, simple press of a button.
  • The cutting-edge technology makes whole-blood sampling and at-home health monitoring both convenient and simple for healthcare professionals and consumers alike.
  • The FDA clearance accelerates opportunities in large-scale clinical trials that have hard-to-reach participant populations, as well as increases patient accessibility in remote monitoring healthcare settings.

Structure Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Friday, March 8, 2024

SAN FRANCISCO, March 08, 2024 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent corporate achievements.

Key Points: 
  • “In 2023 we demonstrated clear proof-of-concept with our lead GLP-1 receptor agonist, GSBR-1290, for obesity and type 2 diabetes.
  • This study is fully enrolled and data are expected in the latter half of the second quarter of 2024.
  • The Company plans to initiate a global Phase 2b obesity study of GSBR-1290 in the fourth quarter of 2024.
  • Net Loss: Net loss for the fourth quarter of 2023 totaled $24.5, with non-cash stock-based compensation expense of $2.1 million, compared to $11.9 million for the fourth quarter of 2022 with non-cash stock-based compensation expense of $0.6 million.

Global Incretin Based Drugs Research Report 2023: Market Analysis by Glucagon-like Peptide-1 Receptor Agonists, Dipeptidyl Peptidase-4 Inhibitors - Market Insights and Forecasts 2019-2029 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, February 21, 2024

The "Global Incretin Based Drugs Market (2023 Edition): Analysis By Drug Type (Glucagon-like Peptide-1 Receptor Agonists, Dipeptidyl Peptidase-4 Inhibitors), Route of Administration, By Indication, By Region, By Country: Market Insights and Forecast (2019-2029)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Incretin Based Drugs Market (2023 Edition): Analysis By Drug Type (Glucagon-like Peptide-1 Receptor Agonists, Dipeptidyl Peptidase-4 Inhibitors), Route of Administration, By Indication, By Region, By Country: Market Insights and Forecast (2019-2029)" report has been added to ResearchAndMarkets.com's offering.
  • During the forecast period, 2024-2029, the Global Incretin Based Drugs market is expected to grow at a CAGR of 6.8%.
  • The Global Incretin Based Drugs Market is expected to generate USD 64.28 billion by the end of 2029, up from USD 40.72 Billion in 2022.
  • Global Incretin Based Drugs Market: Historic and Forecast (2018-2028)
    Estimated number of individuals with Diabetes Worldwide, in thousands (2000-2014E)
    Global Incretin Based Drugs Market: Market Value Assessment, 2018-2028 (USD Billion)
    Global Incretin-Based Drugs Market Segmentation: By Drug Type
    Global Incretin Based Drugs Market Size, By Glucagon-like Peptide-1 Receptor Agonists, By Value, 2018H-2028F (USD Billion & CAGR)
    Global Incretin Based Drugs Market Size, By Dipeptidyl Peptidase-4 Inhibitors, By Value, 2018H-2028F (USD Billion & CAGR)
    Global Incretin-Based Drugs Market Segmentation: By Route of Administration
    Global Incretin-Based Drugs Market Size, By Oral, By Value, 2018H-2028F (USD Billion & CAGR)
    Global Incretin-Based Drugs Market Size, By Injectables, By Value, 2018H-2028F (USD Billion & CAGR)
    Global Incretin Based Drugs Market Segmentation: By Indication
    Global Incretin Based Drugs Market, By Indication Overview
    Global Incretin Based Drugs Market Size, By Diabetes By Value, 2018H-2028F (USD Billion & CAGR)
    Global Incretin Based Drugs Market Size, By Obesity, By Value, 2018H-2028F (USD Billion & CAGR)

SES Notify Fast-Tracks Delivery of Retina Labs' Diabetic Retinopathy Diagnosis to Close Care Gaps and Reduce the $500M in Healthcare Spend

Retrieved on: 
Friday, March 8, 2024

Diabetic retinopathy afflicts nearly one-third of adults over age 40 with diabetes-related blindness accounting for an estimated $500 million in annual healthcare spending.

Key Points: 
  • Diabetic retinopathy afflicts nearly one-third of adults over age 40 with diabetes-related blindness accounting for an estimated $500 million in annual healthcare spending.
  • Diabetic retinopathy is a considerable healthcare problem that threatens vision and can lead to blindness if left undetected.
  • Retina Labs provides in-home diabetic eye exams for patients to quickly and easily screen for diabetic retinopathy and other ocular conditions, with results communicated immediately to patients and their primary care providers using SES Notify.
  • "SES is thrilled to partner with Retina Labs to facilitate immediate delivery of critical diabetic ocular and related disease information," said Michele Darnell, President, Secure Exchange Solutions.

Real-World Data Show Abbott's FreeStyle Libre® Systems and GLP-1 Medicines Work Better Together for People with Type 2 Diabetes

Retrieved on: 
Wednesday, March 6, 2024

These findings were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) held in Florence, Italy, on March 6, 2024.

Key Points: 
  • These findings were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) held in Florence, Italy, on March 6, 2024.
  • GLP-1 medicines – also known as glucagon-like peptide-1 receptor agonist (GLP-1 RA) - are increasingly being prescribed for people with Type 2 diabetes as they provide glycemic benefit and support weight loss.
  • "While treating my patients, I've observed that when we've added a CGM, like the FreeStyle Libre technology, to their GLP-1 therapy, we see even better glycemic control.
  • To maximize the benefits of GLP-1 medicines, it's worth considering the combination of a CGM to support people who live with Type 2 diabetes."