NAFLD

Akero Therapeutics Announces First Patients Dosed in Efruxifermin Phase 3 SYNCHRONY Program

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Lunedì, Dicembre 18, 2023
NAFLD, Marketing, Histology, FDA, Injection, Liver injury, EFX, SAN, Cirrhosis, Therapy, Lipid, DSM-IV codes, Patient, Safety, Diabetes, Fibrosis

SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported patients have received their first doses of efruxifermin (EFX) in the SYNCHRONY Phase 3 program. Two parallel, randomized, placebo-controlled trials have commenced: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic nonalcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis (NASH/MASH), and SYNCHRONY Real-World assessing safety and tolerability of EFX in patients with non-invasively diagnosed NASH/MASH or non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease (NAFLD/MASLD).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported patients have received their first doses of efruxifermin (EFX) in the SYNCHRONY Phase 3 program.
  • “We are thrilled to have dosed the first patients in our Phase 3 program and are delighted with the current level of engagement by clinicians and patients,” said Kitty Yale, chief development officer of Akero.
  • After 52 weeks, patients will continue treatment as randomized in SYNCHRONY Histology to be followed for long-term clinical outcomes, such as progression to cirrhosis.
  • SYNCHRONY Real-World is expected to enroll approximately 600 patients with NASH/MASH or NAFLD/MASLD diagnosed by non-invasive tests to receive weekly injections of EFX 50mg or placebo.

Skye Announces Clinical Development Plan in Obesity for Differentiated Peripheral CB1 Inhibitor, Nimacimab

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Lunedì, Dicembre 11, 2023
GIP, NAFLD, Traffic barrier, Cholesterol, Food, Șaeș, IND, Non-alcoholic fatty liver disease, Drug discovery, FDA, Kidney disease, Weight loss, Syringe, Trial of the century, Half-life, Obesity, Investigational New Drug, Chronic kidney disease, OTCQB, CNS, CB1, Biomarker, Prediabetes, Central nervous system, Patient, Safety, Albuminuria, Pharmaceutical industry

SAN DIEGO, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye"), a pharmaceutical company developing drugs targeting the endocannabinoid system, announced today that it plans to develop nimacimab, the Company’s monoclonal antibody recently acquired from Bird Rock Bio, for weight loss and the treatment of obesity. The Company has filed an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase 2 clinical study of nimacimab in patients with obesity and chronic kidney disease.

Key Points: 
  • Nimacimab is a negative-allosteric modulating antibody targeting the cannabinoid 1 receptor ("CB1"), which has been implicated as an important target in multiple cardiometabolic diseases including obesity and renal complications.
  • Obesity and kidney disease are highly correlated: 80% of patients who have kidney disease are also obese; 30% of obese patients have kidney disease.
  • Nimacimab effectively inhibits CB1 signaling and, based on preclinical and early clinical studies, is devoid of the CNS liabilities typically seen by small molecule drugs that target the CB1 receptor because it does not cross the blood-brain barrier.
  • Skye owns the worldwide rights to nimacimab, with patents issued in the U.S. and other territories including claims to cannabinoid 1 receptor antibodies with inverse agonist function.

BullFrog AI Launches Preclinical Study to Investigate BF-114’s Potential in Battling Obesity

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Mercoledì, Dicembre 6, 2023
NAFLD, Risk, NASH, MOA, Non-alcoholic fatty liver disease, Small RNA, Michigan Medicine, Diabetes, Bullfrog, Obesity, University, Fatty liver disease, University of Michigan, DSM-IV codes, Artificial intelligence, Machine learning, SPTBN1, Medical device

GAITHERSBURG, Md., Dec. 06, 2023 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced the launch of a preclinical study to evaluate the efficacy of its drug candidate BF-114 in obesity. The study, which will be conducted in collaboration with Randy Seeley, Ph.D., the Henry King Ransom Endowed Professor of Surgery at Michigan Medicine, the academic medical center of University of Michigan, and Director of the Michigan Nutrition Obesity Research Center, is designed to evaluate the ability of BF-114 to modulate obesity in an established animal model and to elucidate the mechanism of action (MOA). The study is expected to be completed in the second quarter of 2024 and will complement internal activities that leverage the Company’s AI platform to identify and address new pathways for targeting obesity and metabolic diseases.

Key Points: 
  • The study is expected to be completed in the second quarter of 2024 and will complement internal activities that leverage the Company’s AI platform to identify and address new pathways for targeting obesity and metabolic diseases.
  • Obesity affects over 40% of the US population and is associated with increased risk of heart disease and diabetes.
  • Medical care costs for obesity-related health problems were estimated to be in excess of $170 billion in 2019.
  • “The market for obesity drugs is projected to exceed $77 billion by 2030 , and pharmaceutical companies around the world have recognized the importance of targeting multiple pathways to treat this condition,” said Vin Singh, CEO of BullFrog AI.

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

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Giovedì, Novembre 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.

Akero Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

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Lunedì, Novembre 13, 2023
NAFLD, Safety, SAN, Therapy, Cirrhosis, Clinical trial, Patient, DSM-IV codes, Diabetes, Lipid, Lipoprotein, Research, Liver injury, FDA, Extrapyramidal system, EFX, CMO, Biomarker, Fibrosis, AND, Histology, NASH, F4, Biopsy, Pharmaceutical industry, Medical imaging, Cryptocurrency, Åkerö

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period ending September 30, 2023 and provided business updates.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period ending September 30, 2023 and provided business updates.
  • Key secondary endpoints will include changes in biomarkers of liver fibrosis as well as measures of glycemic control and lipids.
  • Akero's cash, cash equivalents and short-term and long-term marketable securities for the period ended September 30, 2023 were $613.0 million.
  • Total operating expenses were $46.6 million for the three-month period ended September 30, 2023, compared to $36.1 million for the comparable period in 2022.

Sagimet Biosciences Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

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Lunedì, Novembre 13, 2023
Diet, NAFLD, Three Months, Progression-free survival, Glioblastoma, Bevacizumab, AASLD, GBM, Clinical trial, Patient, Research, Liver, IPO, Abstract, R, Congress, FASN, Human, NASH, Acne, Fibrosis, Pharmaceutical industry, Medical imaging, Cryptocurrency, Boston, G&A, Venereology, Dermatology

SAN MATEO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways, today reported financial results for the third quarter ended September 30, 2023, and provided recent corporate updates.

Key Points: 
  • Revenues for the third quarter ended September 30, 2023 were $2.0 million compared to no revenues for the third quarter of 2022.
  • Research and development (R&D) expense for the third quarter ended September 30, 2023 was $5.0 million compared to $6.8 million for the third quarter of 2022.
  • Net loss for the third quarter ended September 30, 2023 was $6.4 million compared to a net loss of $7.5 million for the third quarter of 2022.
  • The net loss for the nine months ended September 30, 2023 totaled $19.7 million compared to $23.3 million for the same period in 2022.

Sagimet Biosciences Presents Preclinical Results Supporting the Therapeutic Potential of its FASN inhibitor in Combination with Semaglutide and a Comprehensive Lipidomic Analysis of Interim FASCINATE-2 Data at AASLD - The Liver Meeting® 2023

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Venerdì, Novembre 10, 2023
Hepatology, NAFLD, SAN, NAS, ALT, Cirrhosis, AASLD, Mouse, Patient, Research and development, Lipid, Week, Doctor of Philosophy, Artificial intelligence, Liver, Semaglutide, Biopsy, Fatty liver disease, Biomarker, FASN, NASH, Fibrosis, Pharmaceutical industry, Research, Boston

SAN MATEO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways, today announced the presentation of preclinical results detailing artificial intelligence (AI) based digital pathology of Sagimet’s FASN inhibitor alone or in combination with semaglutide in a preclinical mouse model of nonalcoholic steatohepatitis (NASH). A comprehensive lipidomic analysis from the interim analysis of the FASCINATE-2 Phase 2b clinical trial will also be presented in a late-breaking poster session at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 held November 10-14, 2023 in Boston.

Key Points: 
  • A single treatment of a FASN inhibitor or semaglutide - improved the NAFLD activity score, or NAS, (NAS ≥ 1 point, 47% and 56%, respectively).
  • The combination of a FASN inhibitor and semaglutide showed further improvement of NAS (94%, p
  • Semaglutide reduced body weight by >20% in NASH mice, alone, or in combination with a FASN inhibitor.
  • The digital AI pathology assessment showed that treatment with a FASN inhibitor alone, or in combination with semaglutide significantly reduced liver fibrosis (p

ENDRA Life Sciences Reports Third Quarter 2023 Financial Results and Provides Business Update

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Martedì, Novembre 14, 2023
Radiology, Health, Clinical Trials, Medical Devices, Proton, Sale, Magnetic resonance imaging, Hepatology, NAFLD, NDRA, Research, De novo, Food, Endocrinology, International, Magnetic resonance, PIN, Agency, FDA, Non-alcoholic fatty liver disease, Marketing, Liver, De novo synthesis, ATM, NPV, Fatty liver disease, Medical imaging, Video game

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • Highlights from the third quarter of 2023 and recent weeks include:
    Shared positive TAEUS clinical data at the Steatotic Liver Disease Summit™ 2023 hosted by the European Association for the Study of the Liver.
  • TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.87.
  • During the third quarter of 2023 and recent weeks, ENDRA was issued six additional patents, including two in the U.S., two in Europe and two in China.

Boston Pharmaceuticals Announces Positive Phase 2a Data Supporting Once-monthly Dosing With Investigational BOS-580 in NASH and Treatment Effects in Diabetic Subgroups at AASLD The Liver Meeting® 2023

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Venerdì, Novembre 10, 2023
Health, Diabetes, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hepatitis, Hepatology, NAFLD, Liver disease, Insulin resistance, AASLD, Cirrhosis, Doctor of Pharmacy, Risk, Fatty liver disease, Patient, C-peptide, Metabolism, FGF21, Liver injury, Non-alcoholic fatty liver disease, Liver, Biomarker, Glycated hemoglobin, Medication, NASH, Fibrosis, Pharmaceutical industry, Boston

Results support a once-monthly dosing schedule for BOS-580 and the positive effects of treatment for people living with NASH who are at risk for or have type 2 diabetes.

Key Points: 
  • Results support a once-monthly dosing schedule for BOS-580 and the positive effects of treatment for people living with NASH who are at risk for or have type 2 diabetes.
  • These data are being presented on Saturday, Nov. 11, 2023, at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in Boston.
  • The normal, pre-diabetic and diabetic sub-populations showed very similar reductions (57-66%) in hepatic fat fraction (HFF) after 12 weeks of BOS-580 treatment.
  • “BOS-580 treatment appears promising in maintaining healthy HbA1c levels among patients with phenotypic NASH, irrespective of their concurrent type 2 diabetes status.

NAD-based Anti-Aging Market to Record an Exponential CAGR by 2031 - Exclusive Report by InsightAce Analytic

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Giovedì, Dicembre 14, 2023
Elysium, NAFLD, Research, NAD, Prevalence, Incidence, Antioxidant, Clinical trial, Skin, NMN, Non-alcoholic fatty liver disease, Blood, Elasticity, Ageing, Growth, Patent, Pharmaceutical industry, Renewable energy, Beauty salon

Moreover, the growing demand for different anti-aging skincare products due to the surging geriatric population worldwide is estimated to bloom the market growth during the projected period.

Key Points: 
  • Moreover, the growing demand for different anti-aging skincare products due to the surging geriatric population worldwide is estimated to bloom the market growth during the projected period.
  • Also, the high cost of anti-aging products is limiting the growth of the NAD-based anti-aging market.
  • The NAD-based Anti-Aging Market in North America is expected to hold the largest market share in revenue over the forecast period.
  • Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type