European Association for the Study of Diabetes

Applied Therapeutics Reports Third Quarter 2023 Financial Results

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Thursday, November 9, 2023
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NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics, presented the data in an oral Symposium entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes.
  • Cash and cash equivalents and short-term investments totaled $37.5 million as of September 30, 2023, compared with $30.6 million at December 31, 2022.
  • Net loss for the third quarter of 2023 was $42.4 million, or $0.47 per basic and diluted common share, compared to a net loss of $19.1 million, or $0.40 per basic and diluted common share, for the third quarter 2022.

Biora Therapeutics Presents Data on the BioJet™ Systemic Oral Delivery Platform at the 59th Annual Meeting of the European Association for the Study of Diabetes

Retrieved on: 
Thursday, October 5, 2023
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(Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, presented data on oral delivery of a GLP-1 receptor agonist with its BioJet systemic oral delivery platform in a short oral discussion titled “Evaluation of the Pharmacokinetics of Glucagon-Like-Peptide-1 Receptor Agonist Delivered through the BioJet™ Biotherapeutic Delivery Platform in Swine” at the 59th annual meeting of the European Association for the Study of Diabetes, in Hamburg, Germany.

Key Points: 
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, presented data on oral delivery of a GLP-1 receptor agonist with its BioJet systemic oral delivery platform in a short oral discussion titled “Evaluation of the Pharmacokinetics of Glucagon-Like-Peptide-1 Receptor Agonist Delivered through the BioJet™ Biotherapeutic Delivery Platform in Swine” at the 59th annual meeting of the European Association for the Study of Diabetes, in Hamburg, Germany.
  • “In recent studies, we assessed the bioavailability of semaglutide when delivered via our autonomous next-generation BioJet device in a porcine model.
  • The studies included single, approximately 1 mg doses of semaglutide in a liquid formulation delivered via the BioJet device.
  • The presentation can be viewed on the European Association for the Study of Diabetes website and is also available on the Biora Therapeutics website .

Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease

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Thursday, October 5, 2023
Cardiovascular disease, III, BMI, Type 2 diabetes, European Association for the Study of Diabetes, Hypertension, Obesity, Prevalence, A1C, Disease, Overweight, Principal, Conditional sentence, EASD, Phase, Appetite, Dyslipidemia, Chronic kidney disease, Obstructive sleep apnea, BI, Zealand Pharma, Boehringer Ingelheim, University college, Risk, Pharmaceutical industry, Electric motor, Dietary supplement, Diabetes

Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease

Key Points: 
  • Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease
    SYNCHRONIZE-1 and SYNCHRONIZE-2 are global Phase III studies of survodutide (BI 456906) in people living with obesity and overweight without and with type 2 diabetes, respectively
    A third study, SYNCHRONIZE-CVOT, is a global, long-term cardiovascular safety study of survodutide in people living with obesity and overweight with cardiovascular disease, chronic kidney disease or with risk factors for cardiovascular disease
    Boehringer Ingelheim and Zealand Pharma A/S (NASDAQ: ZEAL) announced the initiation of three Phase III trials investigating survodutide (also known as BI 456906) for people living with overweight or obesity.
  • The trial design builds upon learnings from Phase II, in which people living with overweight or obesity achieved up to 19 percent weight loss.1 The Phase III trials will soon open for recruitment.
  • SYNCHRONIZE-1 will enrol people without type 2 diabetes (A1C
  • The third study, SYNCHRONIZE-CVOT, is a Phase III trial that will enrol people with overweight or obesity with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease.

Phase III Studies to Investigate Survodutide for People Living with Obesity and Overweight, with and without Diabetes, Cardiovascular Disease and Chronic Kidney Disease

Retrieved on: 
Thursday, October 5, 2023
Diabetes, Health, Pharmaceutical, Clinical Trials, Cardiology, BMI, European Association for the Study of Diabetes, Multimedia, Hypertension, Obesity, Prevalence, A1C, Ingelheim am Rhein, Disease, Overweight, Principal, Conditional sentence, EASD, Phase, Appetite, Dyslipidemia, Obstructive sleep apnea, BI, Zealand Pharma, Boehringer Ingelheim, University college, Pharmaceutical industry

Boehringer Ingelheim and Zealand Pharma A/S (NASDAQ: ZEAL) announced the initiation of three Phase III trials investigating survodutide (also known as BI 456906) for people living with overweight or obesity.

Key Points: 
  • Boehringer Ingelheim and Zealand Pharma A/S (NASDAQ: ZEAL) announced the initiation of three Phase III trials investigating survodutide (also known as BI 456906) for people living with overweight or obesity.
  • The trial design builds upon learnings from Phase II, in which people living with overweight or obesity achieved up to 19 percent weight loss.1 The Phase III trials will soon open for recruitment.
  • SYNCHRONIZE-1 will enroll people without type 2 diabetes (A1C
  • The third study, SYNCHRONIZE-CVOT, is a Phase III trial that will enroll people with overweight or obesity with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease.

Fractyl Health Demonstrated Significant Improvement in Weight Loss in Head-to-Head Preclinical Obesity Studies of its Rejuva® GLP-1-Based Pancreatic Gene Therapy Candidate (GLP-1 PGTx) Compared to Chronic Semaglutide at EASD’s Annual Meeting

Retrieved on: 
Wednesday, October 4, 2023
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During the oral presentation today, the company presented late-breaking results from an additional, second efficacy model of metabolic disease, the well-validated DIO rodent model of obesity.

Key Points: 
  • During the oral presentation today, the company presented late-breaking results from an additional, second efficacy model of metabolic disease, the well-validated DIO rodent model of obesity.
  • A single dose of a GLP-1 PGTx was compared to chronic semaglutide 10 nmol/kg/day in a head-to-head study.
  • GLP-1 PGTx demonstrated improved weight loss compared to semaglutide at day 15, with 24.8% weight loss for GLP-1 PGTx vs. 18.4% weight loss for semaglutide (p
  • Both semaglutide and GLP-1 PGTx treatment arms saw reduced food intake compared to vehicles that persisted through day 15, providing a mechanistic explanation for the weight loss in these animals.

AMRA Used in Tirzepatide Analyses Evaluating the Effect on Muscle Composition via MRI

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Tuesday, October 3, 2023
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Two analyses have shed light on an important factor when evaluating treatments that significantly reduce bodyweight: their effect on muscle composition.

Key Points: 
  • Two analyses have shed light on an important factor when evaluating treatments that significantly reduce bodyweight: their effect on muscle composition.
  • For their multicenter SURPASS-3 MRI study, Eli Lilly and Company selected AMRA® Researcher to measure muscle volume and muscle fat infiltration.
  • The two analyses presented at the European Association for the Study of Diabetes (EASD) annual meeting this year aim to better understand the effect of tirzepatide on muscle composition.
  • The second analysis examined the effect of tirzepatide on muscle composition (both muscle fat infiltration and muscle volume) using longitudinal data from the UK Biobank imaging study to contextualize the observed changes.

VALBIOTIS SA: the Phase II/III REVERSE-IT study selected for an oral presentation at the 2023 EASD congress, the main European learned society for diabetes

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Monday, October 2, 2023
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VALBIOTIS SA: the Phase II/III REVERSE-IT study selected for an oral presentation at the 2023 EASD congress, the main European learned society for diabetes

Key Points: 
  • VALBIOTIS SA: the Phase II/III REVERSE-IT study selected for an oral presentation at the 2023 EASD congress, the main European learned society for diabetes
    Dissemination of a French Regulatory News, transmitted by EQS Group.
  • Valbiotis: the Phase II/III REVERSE-IT study selected for an oral presentation at the 2023 EASD congress, the main European learned society for diabetes
    The Phase II/III clinical study REVERSE-IT, carried out with the active substance TOTUM•63, in partnership with Nestlé Health Science, will be presented on October 3, during an oral communication at the congress of the European Association for the Study of Diabetes (EASD) 2023.
  • This communication will detail the protocol of the REVERSE-IT study, against early glycemic disorders, as well as the complete characteristics of the population included (636 volunteers), at the beginning of the study.
  • “The success of the REVERSE-IT study constitutes a breakthrough for a non-drug approach to prediabetes and untreated early stages of type 2 diabetes.

Dexcom Solidifies Global Leadership in Continuous Glucose Monitoring With New Clinical Data Presented at EASD

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Monday, October 2, 2023
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Regardless of insulin delivery method, multiple daily injections or insulin pump therapy, real-time CGM has greater and statistically significant HbA1c reduction when compared to self-monitoring blood glucose over seven years.

Key Points: 
  • Regardless of insulin delivery method, multiple daily injections or insulin pump therapy, real-time CGM has greater and statistically significant HbA1c reduction when compared to self-monitoring blood glucose over seven years.
  • This news follows the recent launch of the Omnipod 5 Automated Insulin Delivery System connected to Dexcom G6 in the UK and Germany.
  • “Championing access to real-time CGM technology for people with all types of diabetes is central to our mission at Dexcom,” said Alex Moussa, senior vice president and general manager of EMEA & LATAM at Dexcom.
  • “With Dexcom G7, Dexcom G6 and Dexcom ONE, we have the most complete portfolio of CGM systems for people with all types of diabetes and we continue to work on expanding access to our life-changing technology.

SIBIONICS to Make Debut at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD)

Retrieved on: 
Sunday, October 1, 2023
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SHENZHEN, China, Sept. 30, 2023 /PRNewswire/ -- The 59th Annual Meeting of the European Association for the Study of Diabetes (EASD) is set to take place from October 2nd to 6th, 2023, in Hamburg, Germany.

Key Points: 
  • SHENZHEN, China, Sept. 30, 2023 /PRNewswire/ -- The 59th Annual Meeting of the European Association for the Study of Diabetes (EASD) is set to take place from October 2nd to 6th, 2023, in Hamburg, Germany.
  • Established in 2015, SIBIONICS is a high-tech firm specializing in the integration of implantable medical hardware technology and artificial intelligence algorithms.
  • The product is on the verge of obtaining CE certification from the European Union, promising a more scientifical and personalized approach to diabetes management for global users.
  • Additionally, SIBIONICS will present the SiBio KS1 Continuous Ketone Monitoring (CKM) System, a bio-wearable for metabolic management.

SIBIONICS to Make Debut at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD)

Retrieved on: 
Sunday, October 1, 2023
CGM, CKM, CE, CLM, Intelligence, Certification, EASD, Carmine Di Sibio, Patient, Algorithm, European, KS1, Artificial intelligence, European Association for the Study of Diabetes, Medical device, Diabetes

SHENZHEN, China, Oct. 1, 2023 /PRNewswire/ -- The 59th Annual Meeting of the European Association for the Study of Diabetes (EASD) is set to take place from October 2nd to 6th, 2023, in Hamburg, Germany.

Key Points: 
  • SHENZHEN, China, Oct. 1, 2023 /PRNewswire/ -- The 59th Annual Meeting of the European Association for the Study of Diabetes (EASD) is set to take place from October 2nd to 6th, 2023, in Hamburg, Germany.
  • Established in 2015, SIBIONICS is a high-tech firm specializing in the integration of implantable medical hardware technology and artificial intelligence algorithms.
  • The product is on the verge of obtaining CE certification from the European Union, promising a more scientifical and personalized approach to diabetes management for global users.
  • Additionally, SIBIONICS will present the SiBio KS1 Continuous Ketone Monitoring (CKM) System, a bio-wearable for metabolic management.