NASH

Inventiva announces the randomization of the first patient in China in the NATiV3 clinical trial and provides an update on its clinical development program

Retrieved on: 
Wednesday, December 20, 2023
Phase, Marketing, GLP1, Food, MRI, Risk, NASH, Euronext Paris, FDA, Breakthrough therapy, DMC, Disease, European, Diabetes, Clinical trial, Glycated hemoglobin, LEGEND, Lipid, Fatty liver disease, NMPA, EIB, Data monitoring committee, Type 2 diabetes, SGLT2, European Investment Bank, BofA Securities, Patient, T2D, Safety, Fibrosis, Data collection, Magnetic resonance imaging, F4, Scan (company), Pharmaceutical industry

The first patient was randomized in China in the NATiV3 Phase III clinical trial, triggering a milestone payment of $3 million from CTTQ to Inventiva.

Key Points: 
  • The first patient was randomized in China in the NATiV3 Phase III clinical trial, triggering a milestone payment of $3 million from CTTQ to Inventiva.
  • Analysis of the baseline characteristics of all patients randomized in the main cohort suggests a patient profile aligned with those of patients randomized in the NATIVE Phase II clinical trial.
  • Lanifibranor continues to show a favorable tolerability profile as confirmed by the third Data Monitoring Committee2 of November 2023.
  • Topline results of the proof-of-concept Phase II clinical trial, LEGEND, evaluating lanifibranor in combination with empagliflozin are expected in the first quarter of 2024.

EVerZom: Therapeutic Ambition in Exosome Biotherapies

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Wednesday, December 13, 2023
Urine, RNA, Liver, Quality of life, Dicarboxylic acid, Protein, Partnership, NASH, IND, Big Pharma, Acute liver failure, Saliva, Crohn's disease, Regenerative medicine, Lung cancer, Diffusion, Blood, Doctor of Philosophy, Cirrhosis, Fistula, Accelerator, Exosome, Lipid, FedEx, CNRS, Engineering, EIC, Cell, Patient, Publication, Safety, Therapy, Pharmaceutical industry

Paris, December 13, 2023 - EverZom, a CNRS/University Paris Cité spin-off specializing in exosomes, today unveils its proprietary pipeline of exosome biotherapies developed thanks to its proprietary innovation platform.

Key Points: 
  • Paris, December 13, 2023 - EverZom, a CNRS/University Paris Cité spin-off specializing in exosomes, today unveils its proprietary pipeline of exosome biotherapies developed thanks to its proprietary innovation platform.
  • This revolutionary drug modality constitutes a new therapeutic era for acellular off the shelf therapeutics, opening up new opportunities in cell and gene therapy.
  • This platform addresses the entire technological value chain, from cell to patient: cell sourcing, exosome generation, engineering and formulation.
  • Leveraging its innovation platform, EVerZom’s ambition is to develop its pipeline of proprietary biotherapies in regenerative medicine, while building partnerships in several other indications.

Hepion Pharmaceuticals Announces Restructuring Plan to Enhance Shareholder Value and Management Changes

Retrieved on: 
Thursday, December 7, 2023
HEPA, NASH, Sale, Drug development, Acquisition, Conditional sentence, Disclosure, Clinical trial, Artificial intelligence, Fatty liver disease, Investment, Patient, Pharmaceutical industry

EDISON, N.J., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that its Board of Directors has approved a strategic restructuring plan with the objective of preserving capital by initially reducing operating costs by approximately 60% going forward. As a result, Hepion will incur a one-time restructuring charge of approximately $400 – $800 thousand that will be recorded in the fourth quarter of 2023.

Key Points: 
  • As a result, Hepion will incur a one-time restructuring charge of approximately $400 – $800 thousand that will be recorded in the fourth quarter of 2023.
  • Additionally, the Company has initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape.
  • Currently 131 patients are being treated in our Phase 2b (“ASCEND-NASH”) clinical trial.
  • Robert is leaving for personal reasons, and we wish him all the best,” commented Gary S. Jacob, Ph.D., Chairman of the Hepion Board.

Aligos Therapeutics Presents Positive Clinical Data at Hep-DART 2023 from Phase 1 Studies in HBV (ALG-000184) and NASH (ALG-055009)

Retrieved on: 
Thursday, December 7, 2023
Liver, AASLD, Multiple, NASH, SHBG, HBV, MBA, SAN, Therapy, Thyroid, THR, Doctor of Philosophy, HBeAg, CccDNA, Safety, Patient, Pharmacology, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, delivered oral presentations of clinical data for its capsid assembly modulator-empty (CAM-E), ALG-000184, and its thyroid hormone receptor-beta (THR-β) drug candidate, ALG-055009, at the Hep-DART 2023 meeting, held in Cabo San Lucas, Mexico, from December 3 – 7, 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, delivered oral presentations of clinical data for its capsid assembly modulator-empty (CAM-E), ALG-000184, and its thyroid hormone receptor-beta (THR-β) drug candidate, ALG-055009, at the Hep-DART 2023 meeting, held in Cabo San Lucas, Mexico, from December 3 – 7, 2023.
  • The presentations can be found on the “Scientific Presentations & Conferences” section of the Aligos website ( www.aligos.com ).
  • “We’re greatly encouraged by the substantial and consistent reductions in HBV viral markers observed during prolonged dosing of ALG-000184 and are grateful for the opportunity to share these results with the scientific community at the Hep-DART 2023 meeting,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics.
  • As presented at AASLD, ALG-055009 appears to have best-in-class potential.

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

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Thursday, December 7, 2023
Liver, UDCA, Chapter Two, Woman, FDA, MAA, Fatigue, Nausea, Primary biliary cholangitis, Inflammation, ADR, Patent, Liver disease, Diagnosis, AMF, CHMP, Ascending cholangitis, UCD, Business, ACLF, PDUFA, Itch, Risk, New Drug Application, OA, Common, EASL, MASH, Liver failure, Safety, Ammonia, Elafibranor, Therapy, Epidemiology, History, Patient, Cholangiocarcinoma, Food, Health care, EMA, Ursodeoxycholic acid, MHRA, Cirrhosis, Medicine, NTZ, EVP, Cholestasis, NASH, Research, Diarrhea, Bile, NDA, PBC, Abdominal pain, Clinical trial, European Medicines Agency, IPN, PPAR, P10, CCA, Fibrosis, Pharmaceutical industry

An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.

Key Points: 
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The trial enrolled 161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo.
  • ELATIVE also investigated the effect of treatment with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC.
  • Findings from the secondary endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.

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

Retrieved on: 
Wednesday, December 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.

Organovo Provides Timing for Release of FXR314 Phase 2 NASH Results

Retrieved on: 
Wednesday, December 6, 2023
Biology, IBD, Partnership, FXR, Aes, NASH, Inflammatory bowel disease, Primary biliary cholangitis, Tissue, SAN, Cirrhosis, Clinical trial, Fatty liver disease, Patient, Safety, Ulcerative colitis, Pharmaceutical industry

The release of this data will be the first public release of the completed clinical trial data.

Key Points: 
  • The release of this data will be the first public release of the completed clinical trial data.
  • “We are enthusiastic about the opportunity for FXR314 to benefit patients with liver fibrosis, including in NASH and primary biliary cholangitis,” said Keith Murphy, Organovo executive chairman.
  • Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 1H 2024, with targeted completion in 1H 2025.
  • The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that area through partnership collaborations with Organovo.

89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024

Retrieved on: 
Monday, December 4, 2023
Patient, Liver, NASH, Histology, FDA, EMA, SAN, Cirrhosis, Safety, Fibrosis, Pharmaceutical industry

SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced a successful end-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), supporting the advancement of pegozafermin into Phase 3 in NASH. The program will include two Phase 3 trials evaluating patients with NASH: ENLIGHTEN-Cirrhosis will enroll patients with compensated cirrhosis (F4) and ENLIGHTEN-Fibrosis will enroll patients with fibrosis stage F2-F3. The F2-F3 and the F4 trials are expected to initiate in the first quarter and the second quarter of 2024, respectively. Initial scientific advice received from EMA was generally aligned with the feedback from the FDA.

Key Points: 
  • The F2-F3 and the F4 trials are expected to initiate in the first quarter and the second quarter of 2024, respectively.
  • Initial scientific advice received from EMA was generally aligned with the feedback from the FDA.
  • ENLIGHTEN-Cirrhosis, in patients with compensated F4 NASH: The trial will evaluate the efficacy and safety of pegozafermin administered 30mg weekly.
  • Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection.

Inventiva announces the positive recommendation of the third DMC of the Phase III clinical trial with lanifibranor in patients with NASH

Retrieved on: 
Monday, December 4, 2023
NASH, Euronext Paris, DMC, Clinical trial, Fatty liver disease, Data monitoring committee, Patient, Safety, Fibrosis, Pharmaceutical industry

The DMC, composed of a group of independent experts, arrived at this recommendation after review of the safety data of patients enrolled in the NATiV3 trial.

Key Points: 
  • The DMC, composed of a group of independent experts, arrived at this recommendation after review of the safety data of patients enrolled in the NATiV3 trial.
  • The DMC review supports the continuation of the NATiV3 clinical trial, in the absence of a  safety signal that would require any modification to the trial protocol.
  • This safety assessment was based on the review of safety data from more than 500 patients, including patients that have been treated with lanifibranor for more than 72 weeks.
  • This positive recommendation confirms the good safety and tolerability profile of lanifibranor.

Polaris Group Announces First Patient Successfully Dosed with ADI-PEG 20/Placebo in Phase 2a Non-Alcoholic Steatohepatitis (NASH) Study

Retrieved on: 
Thursday, November 30, 2023
NASH, Fatty liver disease, Disease, SAN, Metabolic syndrome, DSM-IV codes, Public, Obesity, Patient, Liver disease, Safety, Pharmaceutical industry

TAIPEI, Taiwan and SAN DIEGO, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the first patient was successfully dosed in the Phase 2a clinical study for Non-Alcoholic Steatohepatitis (NASH).

Key Points: 
  • TAIPEI, Taiwan and SAN DIEGO, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the first patient was successfully dosed in the Phase 2a clinical study for Non-Alcoholic Steatohepatitis (NASH).
  • With limited treatment options available, Polaris Group is committed to developing innovative therapies to address this unmet medical need.
  • "We are excited to reach this pivotal moment in our NASH program," said Howard Chen, Chairman and CEO at Polaris Group.
  • Polaris Group is committed to advancing innovative treatments, and this milestone underscores our dedication to improving patient outcomes."