Non-alcoholic fatty liver disease

ACTG CROI Presentations Show That Semaglutide Improves Metabolic-Associated Steatotic Liver Disease Among People Living With HIV

Retrieved on: 
Tuesday, March 5, 2024

Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.

Key Points: 
  • Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.
  • Together, these presentations demonstrate that semaglutide was highly effective in improving, and in some cases, resolving completely, metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as non-alcoholic fatty liver disease) among people living with HIV.
  • SLIM LIVER is the first study evaluating semaglutide as a treatment for MASLD among people living with HIV.
  • MASLD is common among people living with HIV and likely acts synergistically with HIV to accelerate liver injury and organ dysfunction.

Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada

Retrieved on: 
Wednesday, February 28, 2024

(NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled “An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation”.

Key Points: 
  • (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled “An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation”.
  • This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite.
  • The Company also has a distribution agreement in Canada for its anti-inflammatory drug, Piclidenoson, for the treatment of psoriasis.
  • “This additional patent in Canada for fatty liver disease adds to our growing IP estate for this high-value indication of the Namodenoson drug candidate.

New ICD-10-CM Code by the World Health Organization Paves the Way for Improved NAFLD Diagnostics Including ENDRA Life Sciences’ TAEUS System

Retrieved on: 
Wednesday, February 21, 2024

The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.

Key Points: 
  • The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.
  • These codes are issued by the World Health Organization (WHO) and are used to show payers why a particular service was medically necessary.
  • The inclusion of NAFLD under the ICD-10 K76.0 code facilitates standardized billing for its diagnosis.
  • "This positive development is testament to the growing awareness of liver health and the intensifying need for effective diagnostic solutions.

Americans Still in the Dark: New Data from MyFitnessPal Reveals Sizable Continuing Gaps in Basic Nutritional Knowledge

Retrieved on: 
Thursday, March 7, 2024

NEW YORK, March 7, 2024 /PRNewswire/ -- The beginning of a new year is when health and wellness are top of mind for consumers, but new data reveals ongoing gaps in nutrition knowledge of Americans that could be hindering their personal goals. MyFitnessPal, the leading global nutrition and food tracking app, recently conducted their Nutrition IQ 2.0 survey1, in follow up to initial results from 2022. Trends from the data show that Americans have more to learn in 2024, with the majority of Americans still unaware of the nutritional value and content in their daily diet. With the data showing that Americans' knowledge of nutrition has not deepened significantly over the past two years, MyFitnessPal formed a scientific advisory council to guide the development of nutrition content, tools, and features that support members in achieving their health and nutrition goals.

Key Points: 
  • MyFitnessPal , the leading global nutrition and food tracking app, recently conducted their Nutrition IQ 2.0 survey1, in follow up to initial results from 2022.
  • Trends from the data show that Americans have more to learn in 2024, with the majority of Americans still unaware of the nutritional value and content in their daily diet.
  • Compared to 2022, Americans are still overestimating calorie count and protein content, while underestimating fat and carb content.
  • A majority of Scott's clients are males looking to lose weight, but they're also looking to address longevity and gut health.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

Retrieved on: 
Tuesday, February 13, 2024

PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients between the ages of 18 to 75. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).

Key Points: 
  • HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
  • MASLD is commonly asymptomatic until it progresses to advanced liver fibrosis, and the current gold standard for diagnosis is a liver biopsy, which is invasive and costly.
  • HealthFLD was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
  • It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
    The HealthFLD clearance is the third product across the Nanox AI suite of population health solutions to receive FDA clearance.

OliX Pharmaceuticals Commences Patient Dosing in Phase 1 Clinical Trial of OLX75016 for MASH

Retrieved on: 
Tuesday, February 13, 2024

OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced that the first participant was dosed today with OLX75016.

Key Points: 
  • OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced that the first participant was dosed today with OLX75016.
  • OLX75016 is being developed to provide a novel treatment approach for metabolic dysfunctions associated with non-alcoholic fatty liver disease linked to obesity.
  • The phase 1 trial is ongoing in Brisbane, Australia.
  • This is how we believe OLX75016 is set apart, and we anticipate this novel therapeutic to bring hope to patients with multiple metabolic diseases, starting in phase 1 clinical trial."

Three Journal of Pharmaceutical Analysis Studies Explore the Use of Traditional Chinese Medicine for Various Diseases

Retrieved on: 
Friday, January 26, 2024

XI'AN, China, Jan. 26, 2024 /PRNewswire/ -- Despite demonstrating significant clinical efficacy against various diseases, the widespread use of Traditional Chinese Medicine (TCM) is still limited.

Key Points: 
  • XI'AN, China, Jan. 26, 2024 /PRNewswire/ -- Despite demonstrating significant clinical efficacy against various diseases, the widespread use of Traditional Chinese Medicine (TCM) is still limited.
  • To address this gap, a new issue of the Journal of Pharmaceutical Analysis presents three independent studies which assessed the potency of TCM-based compounds for various human diseases, along with their molecular mechanisms of action.
  • Oridonin (ORI), a TCM derived from the Chinese herb Rabdosia rubescens, exhibits anti-inflammatory effects.
  • These studies provide a scientific basis for the development of TCM-based compounds into effective targeted therapies for various diseases.

Non-Alcoholic Steatohepatitis Treatment Drug Market In Japan is Expected to Showcase Impressive Growth by 2032 | DelveInsight

Retrieved on: 
Wednesday, January 17, 2024

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.

Key Points: 
  • LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.
  • According to DelveInsight's analysis, the market size for NASH reached USD 200 million in 2022 in Japan and is expected to grow with a significant CAGR by 2032.
  • DelveInsight's analysis reveals that the overall diagnosed prevalent population of NASH in Japan was reported as 2.5 million in 2022.
  • Among the forecasted emerging therapies, MGL-3196 (Resmetirom) is expected to capture the highest market in Japan by 2032.

Non-Alcoholic Steatohepatitis Treatment Drug Market In Japan is Expected to Showcase Impressive Growth by 2032 | DelveInsight

Retrieved on: 
Wednesday, January 17, 2024

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.

Key Points: 
  • LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.
  • According to DelveInsight's analysis, the market size for NASH reached USD 200 million in 2022 in Japan and is expected to grow with a significant CAGR by 2032.
  • DelveInsight's analysis reveals that the overall diagnosed prevalent population of NASH in Japan was reported as 2.5 million in 2022.
  • Among the forecasted emerging therapies, MGL-3196 (Resmetirom) is expected to capture the highest market in Japan by 2032.