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Fractyl Health Announces Clinical Update on Revita® Real World Registry in Germany and Launch of Revita+™ Telehealth Program Combining Behavioral Recommendations with Revita Treatment for Type 2 Diabetes

Retrieved on: 
Tuesday, August 1, 2023

Fractyl Health, a metabolic therapeutics company pioneering new approaches to prevent and reverse type 2 diabetes (T2D), today announced clinical updates on the Revita Real World Registry in Germany and the launch of a new telehealth program, called Revita+.

Key Points: 
  • Fractyl Health, a metabolic therapeutics company pioneering new approaches to prevent and reverse type 2 diabetes (T2D), today announced clinical updates on the Revita Real World Registry in Germany and the launch of a new telehealth program, called Revita+.
  • Revita+ is a scalable behavioral modification program created to reduce insulin and glucose excursions.
  • "The initial clinical experiences with Revita DMR in Germany are promising and validate the outcomes observed in previous clinical studies," said Professor Martin.
  • Periodic updates on the Revita Registry and real-world clinical outcomes for patients in Germany undergoing Revita treatment will be shared as the study continues to enroll in more sites.

Strawberry Consumption May Improve Cognitive Function in Older Adults, New Study Says

Retrieved on: 
Wednesday, July 26, 2023

The study was conducted at San Diego State University and builds on previous research demonstrating the cardiovascular, metabolic, and cognitive health benefits of strawberries.

Key Points: 
  • The study was conducted at San Diego State University and builds on previous research demonstrating the cardiovascular, metabolic, and cognitive health benefits of strawberries.
  • Following strawberry consumption, cognitive processing speed increased by 5.2%, systolic blood pressure decreased by 3.6%, and total antioxidant capacity significantly increased by 10.2%.
  • Long-term observational studies, including the Health Professionals Study and the Nurses’ Health Study, found that strawberry consumers had lower rates of cognitive decline.
  • For more information on strawberry research, you can view the California Strawberry Commission’s Health Research Round-Up .

NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROADWAY Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia and/or Established Atherosclerotic Cardiovascular Disease

Retrieved on: 
Tuesday, July 25, 2023

NAARDEN, The Netherlands and MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the completion of patient enrollment in the pivotal Phase 3 BROADWAY clinical trial evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or established atherosclerotic cardiovascular disease (“ASCVD”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally. NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.

Key Points: 
  • The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally.
  • NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.
  • The mean baseline LDL-C for enrolled patients is approximately 100 mg/dL despite high intensity statin use reported by greater than 60% of patients during screening.
  • “It has become increasingly clear that lower levels of LDL-C are directly correlated with a reduced risk for major adverse cardiovascular events.

Strawberry Consumption May Improve Cognitive Function in Older Adults, New Study Says

Retrieved on: 
Monday, July 24, 2023

BOSTON, July 24, 2023 /PRNewswire/ -- Daily strawberry consumption was linked to improved cognitive function, lower blood pressure and higher antioxidant capacity in a randomized clinical trial presented today at Nutrition 2023, the annual meeting of the American Society of Nutrition (ASN). The study was conducted at San Diego State University and builds on previous research demonstrating the cardiovascular, metabolic and cognitive health benefits of strawberries.

Key Points: 
  • The study was conducted at San Diego State University and builds on previous research demonstrating the cardiovascular, metabolic and cognitive health benefits of strawberries.
  • Following strawberry consumption, cognitive processing speed increased by 5.2%, systolic blood pressure decreased by 3.6% and total antioxidant capacity significantly increased by 10.2%.
  • Long-term observational studies, including the Health Professionals Study and the Nurses' Health Study, found that strawberry consumers had lower rates of cognitive decline.
  • For more information on strawberry research, you can view the California Strawberry Commission's Health Research Round-Up .

Corcept’s Miricorilant Shows Great Promise in Treatment of Non-Alcoholic Steatohepatitis (NASH)

Retrieved on: 
Monday, July 17, 2023

These patients also experienced improvements in key metabolic and lipid measures such as HOMA-IR, serum triglycerides and LDL.

Key Points: 
  • These patients also experienced improvements in key metabolic and lipid measures such as HOMA-IR, serum triglycerides and LDL.
  • “Miricorilant is highly active in the liver with a unique mechanism of action and holds great promise for the treatment of NASH,” said Naim Alkhouri, MD, FAASLD, Chief Medical Officer of Arizona Liver Health.
  • “The combination of liver fat reduction, improvement in metabolic and lipid measures and low adverse event rate is compelling.
  • Miricorilant has the potential to be a potent solution for the large patient population with NASH.”

Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

Retrieved on: 
Monday, July 17, 2023

Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.

Key Points: 
  • Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
  • In the pivotal Phase 3 MAESTRO-NASH serial liver biopsy trial, resmetirom achieved both liver histological improvement endpoints – resolution of NASH and reduction of liver fibrosis – proposed by FDA as reasonably likely to predict clinical benefit to support accelerated approval for the treatment of NASH with liver fibrosis.
  • In April 2023, resmetirom was granted Breakthrough Therapy designation by FDA for the treatment of adults with NASH with liver fibrosis.
  • We’d like to thank the many patients and investigators who have contributed to the clinical research supporting the resmetirom NDA.”

EQS-News: SYNLAB AG: SYNLAB plays key role in the largest ever multinational study on cholesterol

Retrieved on: 
Monday, July 17, 2023

SYNLAB (FSE: SYAB), the leader in medical diagnostic services and specialty testing in Europe, provided significant support for the largest ever multi-national study on circulating cholesterol concentrations.

Key Points: 
  • SYNLAB (FSE: SYAB), the leader in medical diagnostic services and specialty testing in Europe, provided significant support for the largest ever multi-national study on circulating cholesterol concentrations.
  • It posits that geographical location and sex as well as cultural and genetic differences influence cholesterol levels.
  • The research, moreover, includes medically recognised laboratory markers of cardiovascular disease risk, including levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides.
  • Of these, the highest mean total cholesterol levels were in Austria (5.40 mmol/L, 208.8 mg/dL) and Germany (5.35 mmol/L, 206.9 mg/dL).

Valbiotis announces its roadmap and strategic priorities on the eve of key milestones for its portfolio of innovative active substances

Retrieved on: 
Wednesday, July 12, 2023

As a reminder, this international, multicenter, randomized, placebo-controlled study was carried out in a population of 636 volunteers with prediabetes and early-stage, untreated type 2 diabetes.

Key Points: 
  • As a reminder, this international, multicenter, randomized, placebo-controlled study was carried out in a population of 636 volunteers with prediabetes and early-stage, untreated type 2 diabetes.
  • The Company is preparing a final Phase II/III clinical stage, which will provide the clinical data required to file a health claim.
  • On the industrial processes front, Valbiotis is continuing to set up the supply chain, from sourcing plant raw materials through to marketing.
  • The sales timetable in France has thus been confirmed, with TOTUM•070 due for launch in the first half of 2024.

Analysis of Half a Billion Lipid Tests from Five Continents Reveals Wide Variation of Heart Disease Lipid Risk by Country and Sex

Retrieved on: 
Monday, July 10, 2023

Published in European Heart Journal , the analysis includes globally recognized laboratory markers of cardiovascular disease risk, including levels of total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, and triglyceride.

Key Points: 
  • Published in European Heart Journal , the analysis includes globally recognized laboratory markers of cardiovascular disease risk, including levels of total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, and triglyceride.
  • The World Health Organization (WHO) and clinical practice guidelines in different countries recognize lipid testing’s clinical value.
  • Of these, the highest mean total cholesterol levels were in Austria (5.40 mmol/L, 208.8 mg/dL) and Germany (5.35 mmol/L, 206.9 mg/dL).
  • While the laboratories involved in the analysis are leaders in their respective countries, their laboratory data may not fully represent any particular country or geography.

Recent Publications Demonstrate Utility of DPNCheck® for Identifying High-Risk Diabetes Patients

Retrieved on: 
Wednesday, June 28, 2023

Ke and colleagues developed and validated an algorithm to predict progression from mild non-proliferative diabetic retinopathy (DR) to vision-threatening DR in type 2 diabetes.

Key Points: 
  • Ke and colleagues developed and validated an algorithm to predict progression from mild non-proliferative diabetic retinopathy (DR) to vision-threatening DR in type 2 diabetes.
  • The model was created by analyzing 440 patients with non-proliferative DR or vision-threatening DR.
  • It was then prospectively validated in 120 patients with mild non-proliferative DR who were followed for a median of 42 months.
  • "It is also evident that traditional clinical screening for peripheral neuropathy is poorly correlated to the underlying pathophysiology of diabetes, which calls into question its utility for identifying high-risk patients."