Steatosis

Protara Therapeutics Announces Alignment with FDA on Registrational Path Forward for IV Choline Chloride in Patients Dependent on Parenteral Nutrition

Retrieved on: 
Friday, April 5, 2024
Choline, Plasma, Liver, Nutritional science, Route of administration, Liver disease, Steatosis, Short bowel syndrome, Metabolism, Patient, Choline chloride, Cancer, ESPEN, Parenteral nutrition, Adolescence, Liver injury, Hepatology, Tubing (recreation), Fibrosis, Guideline, Society, Therapy, Copenhagen University Hospital, Safety, Pharmacokinetics, PN, FDA, ASPEN, Rigshospitalet, Food, Feeding tube, Extractive metallurgy

IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.

Key Points: 
  • IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.
  • The Company plans to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PN.
  • The FDA has granted IV Choline Chloride Orphan Drug Designation for the prevention of choline deficiency in PN patients.
  • “We look forward to advancing the clinical development of IV Choline Chloride, which we believe has the potential to become the first FDA approved IV choline therapy for patients dependent on PN.

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
Diagnosis, Glucose, Histology, Adipose tissue, Arm, Glycated hemoglobin, Type 2 diabetes, Disease, Connective tissue, Steatosis, Insulin, Weight gain, Diabetes, CT1, Patient, Inflammation, SGLT2, Adiponectin, Table, MASH, MD, Liver injury, Insulin resistance, LEGEND, Fibrosis, HDL, Fatty liver disease, Empagliflozin, Safety, Euronext Paris, Phase, NASH, Hepatitis, Lipid metabolism, Prediabetes, Liver disease

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.

NorthSea Therapeutics Initiates Phase 2A Trial of Orziloben (NST-6179) in Intestinal Failure-Associated Liver Disease (IFALD)

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Liver, Collagen, Myofibroblast, PD, Liver disease, Cirrhosis, Learning, Short bowel syndrome, Conference, Hepatology, Liver failure, Safety, Steatosis, Rigshospitalet, PN, Therapy, Pharmacokinetics, Cholestasis, Fatty liver disease, Patient, ASPEN, Fibrosis, Disease, NASH, Pharmaceutical industry

The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.

Key Points: 
  • The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.
  • It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Orziloben in adult subjects with IFALD.
  • Commenting on the milestone, Rob de Ree, NST’s CEO, said: "Dosing the first patient in our Phase 2a trial for Orziloben in IFALD is a significant achievement for NorthSea Therapeutics, and is a testament to our commitment to advance innovative treatments for liver diseases.
  • In one pre-clinical model of PN-induced liver injury, Orziloben treatment completely prevented severe cholestasis and the development of fibrosis.

New ICON Survey Highlights Importance of Combination Therapies in Future Obesity Treatment

Retrieved on: 
Wednesday, January 24, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Diabetes, Fitness & Nutrition, Clinical Trials, Obesity, Patient, GIP, Therapy, MASH, Internal medicine, Hormone, ICON PLC, ICLR, Disease, Safety, Drug development, Liver disease, Steatosis, Clinical trial, Metabolism, Cardiovascular disease, Bariatric surgery, Pharmaceutical industry

The majority of respondents believe the future of obesity therapies lies in trials that are designed to measure more than one outcome.

Key Points: 
  • The majority of respondents believe the future of obesity therapies lies in trials that are designed to measure more than one outcome.
  • There is much overlap between obesity and co-morbidities such as diabetes, steatosis (fatty liver), and cardiovascular disease, and in line with this, most respondents (64%) felt combination therapies would be the primary focus of future research.
  • Obesity is a growing health concern worldwide, with at least 2.8 million people dying each year because of the disease1.
  • There is more to examine on the implications of obesity as a risk factor across the disease spectrum and how it may impact treatment, drug development and clinical trials for obesity.

Kriya Provides Update on Pipeline Progress Ahead of Company Presentation at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Continuity, Diabetes, Entrepreneurship, Risk, C3, Non-alcoholic fatty liver disease, Epilepsy, FDA, CR2, Anticonvulsant, Inflammation, Neuron, Geographic atrophy, Conference, Paratriathlon, Pain, European, Disease, Cmax, Glycated hemoglobin, Trigeminal neuralgia, FGF21, Steatosis, Therapy, Computational biology, Exophthalmos, TED, Diplopia, Varenicline, Smoking, Injection, AAV, CNS, DSM-IV codes, Patient, Graves' ophthalmopathy, Medicine, Seizure, Glucokinase, Neurology, CR1, NASH, Insulin, Brain, GMP, Trigeminal nerve, Ophthalmology, Pathology, Fibrosis, Pharmaceutical industry

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Kriya Therapeutics, Inc., ("Kriya") a biopharmaceutical company developing gene therapies for common diseases affecting millions of people around the world, today provided an update on its pipeline of gene therapies for prevalent conditions including geographic atrophy, thyroid eye disease, diabetes, NASH, trigeminal neuralgia and epilepsy. Kriya is advancing the first of its gene therapy product candidates into the clinic in 2024 and expects up to five programs in the clinic by the end of 2025.

Key Points: 
  • Kriya’s pipeline includes gene therapies across three major therapeutic areas: ophthalmology, metabolic disease and neurology.
  • Its programs share the following features: direct-to-tissue delivery, validated biology, de-risked clinical and regulatory paths and large commercial markets.
  • Dr. Ramaswamy will share further information on Kriya’s portfolio during his presentation at the J.P. Morgan 42nd Annual Healthcare Conference on Tuesday, January 9th at 9:00 AM PT in San Francisco, California.
  • A significant proportion of patients suffer from refractory epilepsy, many of whom are candidates for invasive neurosurgery.

Algernon Pharmaceuticals Receives Notice of Intention to Grant from Chinese Patent Office for Repirinast to Treat NASH and NAFLD

Retrieved on: 
Thursday, November 30, 2023
NAFLD, Risk, NASH, Fatty liver disease, AGN, Type, Inflammation, Standard of care, Patent, Insulin resistance, Laboratory, Obesity, Patient, Telmisartan, Steatosis, Fibrosis, UUO, CKD, Pharmaceutical industry

The invention claims treating lobular inflammation and nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast.

Key Points: 
  • The invention claims treating lobular inflammation and nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast.
  • The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection.
  • The Company was recently issued patents for Repirinast in NASH from the U.S. and Japan, and has also filed corresponding patent applications in Canada and Europe.
  • “We are pleased to receive this notice of intent to grant from the Chinese Patent Office,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals.

Terns Pharmaceuticals Presents Late-Breaking Data from Phase 2a DUET Trial of THR-β Agonist TERN-501 in NASH at AASLD The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
THR, Hepatology, Safety, Magnetic resonance imaging, Steatosis, AASLD, Liver, FXR, Clinical trial, Fatty liver disease, CT1, Patient, Week, Obesity, Houston Methodist Hospital, Non-alcoholic fatty liver disease, Bangladesh Technical Education Board, SHBG, MRI, Biomarker, NASH, DUET, Fibrosis, Pharmaceutical industry, Boston

FOSTER CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), today announced the late-breaking oral presentation of top-line data from its Phase 2a DUET clinical trial of TERN-501, an investigational orally administered thyroid hormone receptor-β (THR-β) agonist for the treatment of NASH. TERN-501 was evaluated alone and in combination with the Company’s liver-distributed farnesoid X receptor (FXR) agonist TERN-101. These data will be presented at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), on Monday, November 13 at 2:00 p.m. ET in Boston, Massachusetts.

Key Points: 
  • TERN-501 was evaluated alone and in combination with the Company’s liver-distributed farnesoid X receptor (FXR) agonist TERN-101.
  • These data will be presented at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), on Monday, November 13 at 2:00 p.m.
  • “These top-line data of TERN-501 are encouraging, with significant reductions in key biomarkers including liver fat content, MRI-PDFF, and cT1, a marker of fibro-inflammation.
  • Terns will host an investor reception event during The Liver Meeting in Boston on Monday, November 13 at 4:00 p.m.

E-Scopics announces commercial launch of Hepatoscope in the US and opens its subsidiary in the USA

Retrieved on: 
Thursday, November 9, 2023
Other Health, Software, General Health, Radiology, Apps, Applications, Medical Devices, Technology, Health Technology, Biotechnology, Other Technology, Health, Diabetes, Chronic liver disease, Physician, SOS, Liver, Speed of sound, Medtech, LSM, Steatosis, Risk, U.S. FDA, Nutritionist, ATT, GLP1, Patient, BSC, UAA Films, Medical imaging

This will enable its nomad use at the point of care, by various clinicians ranging from diabetologists, nutritionists, primary care physicians and beyond.

Key Points: 
  • This will enable its nomad use at the point of care, by various clinicians ranging from diabetologists, nutritionists, primary care physicians and beyond.
  • This new concept of Ultrasound-as-a-Service (UaaS) allows an agile adaptation to specific ultrasound applications to democratize their use to non-expert users.
  • The platform provides ultra-low power ultrasound and ultrafast imaging capability, which can support premium ultrasound modalities in an ultra-portable form factor.
  • “Following our clinical evaluation of Hepatoscope, it becomes clear to me that the device is ideally positioned for screening of MASLD-MASH.

Algernon Pharmaceuticals Receives Japanese Patent Notice of Allowance for Treatment of NASH with Repirinast

Retrieved on: 
Wednesday, November 8, 2023
Standard of care, Patent, Obesity, Laboratory, Fibrosis, Inflammation, CSE, Fatty liver disease, Type, Steatosis, NASH, Risk, UUO, Telmisartan, AGN, NAFLD, CKD, Insulin resistance, Patient, Pharmaceutical industry, Repirinast

VANCOUVER, British Columbia, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that it has received a Notice of Allowance from the Japanese Patent Office for patent application No.

Key Points: 
  • VANCOUVER, British Columbia, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that it has received a Notice of Allowance from the Japanese Patent Office for patent application No.
  • The invention claims treating nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast.
  • The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection.
  • The Company was recently issued a patent from the US patent office for Repirinast in NASH and has also filed corresponding patent applications in Canada, Europe, and China.

Inventiva announces a late breaker abstract and two additional abstracts on its lead compound, lanifibranor, at the AASLD The Liver Meeting® 2023  

Retrieved on: 
Monday, November 6, 2023
Adiponectin, Arm, University, American Association for the Study of Liver Diseases, Hepatology, Diabetes, II, Liver, C-reactive protein, CAP, Genotype, Lipid metabolism, Fibrosis, Metabolic syndrome, PNPLA3, Inflammation, Type 2 diabetes, HOMA-IR, Euronext Paris, Scan (company), Steatosis, NASH, Risk, Insulin, T2D, Abstract, Histology, Serum, MM, Insulin resistance, Adipose tissue, Patient, Fatty liver disease, Metabolism, Glucose, Medical device, Medical imaging, Pharmaceutical industry

The phase II study led by Dr. Kenneth Cusi evaluating lanifibranor in patients with T2D and MASLD was selected as late breaker.

Key Points: 
  • The phase II study led by Dr. Kenneth Cusi evaluating lanifibranor in patients with T2D and MASLD was selected as late breaker.
  • Two additional scientific abstracts from the NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH have been selected  for presentation.
  • The two abstracts show:
    the correlation between the increase of adiponectin under lanifibranor and the improvement of histological and serum markers of NASH severity both in terms of activity and fibrosis.
  • the improvement of liver histology and markers of cardiometabolic health in patients with NASH treated with lanifibranor, independent of PNPLA3 genotype.