FXR

Organovo Presents FXR314 3D Human Tissue Model Findings That Show Improved Epithelial Barrier Function and Fibrosis Reduction at Crohn’s and Colitis Congress

Retrieved on: 
Thursday, January 25, 2024
Probability, Biology, Fibrosis, Organovo, SAN, Tissue, IBD, Inflammatory bowel disease, Cirrhosis, Research and development, Disease, 3D, NASH, Colitis, Ulcerative colitis, FXR, Pharmaceutical industry

FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD.

Key Points: 
  • FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD.
  • FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn’s disease donors.
  • In ulcerative colitis, FXR314 improved epithelial barrier function and fibrotic activity in all donors.
  • Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 2024, with targeted completion in 2025.

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

Retrieved on: 
Wednesday, January 17, 2024
Obesity, Merck & Co., MRI, LAS, Weight loss, Fatty liver disease, Type 2 diabetes, Magnetic resonance imaging, Insulin resistance, NASH, FFAR4, Liver, Liver disease, Diabetes, Alcoholic liver disease, Therapy, Hypertension, PPAR, Eli Lilly and Company, Gilead Sciences, Chronic pain, Disease, Inflammation, FASN, AstraZeneca, Novo Nordisk, FXR, Prevalence, CCR5, FGF, Physical examination, Weakness, Bronchial thermoplasty, Cilofexor, Metabolic syndrome, Mitsubishi Tanabe Pharma, Development, NAFLD, Risk, Fibrosis, Fatigue, Dyslipidemia, USD, Non-alcoholic fatty liver disease, Merck, Pharmaceutical industry

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
Obesity, Merck & Co., MRI, LAS, Weight loss, Fatty liver disease, Type 2 diabetes, Magnetic resonance imaging, Insulin resistance, NASH, FFAR4, Liver, Liver disease, Diabetes, Alcoholic liver disease, Therapy, Hypertension, PPAR, Eli Lilly and Company, Gilead Sciences, Chronic pain, Disease, Inflammation, FASN, AstraZeneca, Novo Nordisk, FXR, Prevalence, CCR5, FGF, Physical examination, Weakness, Bronchial thermoplasty, Cilofexor, Metabolic syndrome, Mitsubishi Tanabe Pharma, Development, NAFLD, Risk, Fibrosis, Fatigue, Dyslipidemia, USD, Non-alcoholic fatty liver disease, Merck, Pharmaceutical industry

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.

Organovo To Present FXR314 IBD 3D Model Findings at Upcoming Crohn’s and Colitis Congress

Retrieved on: 
Tuesday, January 9, 2024
Biology, Fibrosis, Organovo, UC, SAN, Partnership, Tissue, IBD, Inflammatory bowel disease, Executive, Cirrhosis, Research and development, Disease, 3D, NASH, Colitis, Ulcerative colitis, FXR, Ulcer

The invited oral presentation, entitled “Evaluation of the clinical stage FXR agonist FXR314 in human primary cell 3D models of Crohn’s disease and ulcerative colitis”, will be made on Friday, January 26, 2024 at 3:00 PM PST by Dr. Fabrice Piu, Vice President, Research & Development.

Key Points: 
  • The invited oral presentation, entitled “Evaluation of the clinical stage FXR agonist FXR314 in human primary cell 3D models of Crohn’s disease and ulcerative colitis”, will be made on Friday, January 26, 2024 at 3:00 PM PST by Dr. Fabrice Piu, Vice President, Research & Development.
  • “We initially identified a strong benefit of FXR agonism in IBD using our internal 3D models, then moved towards development of what we believe to be a best-in-class FXR agonist, FXR314, to treat IBD,” said Keith Murphy, Organovo's 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.

ENYO Pharma Announces a €39 Million Series C Financing and FDA Clearance to Advance Vonafexor in a Phase 2 Clinical Trial for Patients With Alport Syndrome

Retrieved on: 
Wednesday, January 3, 2024
Research, Finance, FDA, Clinical Trials, Professional Services, Other Health, Biotechnology, Pharmaceutical, Health, Science, Food, FXR, Multimedia, IND, Kidney, Chronic kidney disease, OrbiMed, EMA, Trial of the century, ODD, Clinical trial, ADPKD, Kidney disease, European Medicines Agency, Patient, EGFR, Fibrosis, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240103067331/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240103067331/en/
    Furthermore, ENYO announced the first closing of a 39 million € Series C equity financing, positioning ENYO as an emerging biotechnology company in the field of renal diseases.
  • The financing will support the Phase 2 Alpestria-1 study and further profiling of Vonafexor in other kidney diseases, such as Autosomal Dominant Polycystic Kidney Disease (ADPKD).
  • The clearance of ENYO’s IND represents a significant milestone for the company as it embarks on its first clinical trial focusing on renal disease.
  • ENYO’s lead candidate Vonafexor, as well as fast follower EYP651, are highly specific FXR agonists given as once-daily oral treatments.

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.

Terns Pharmaceuticals Reports Third Quarter 2023 Financial Results and Corporate Updates

Retrieved on: 
Tuesday, November 14, 2023
JD, THR, Research, Safety, Chemistry, Acute leukemia, IND, PD, FXR, Clinical trial, SAD, Overweight, Fatty liver disease, Administration, Patient, DSM-IV codes, Tern, Week, Part, FDA, Obesity, Pharmacokinetics, BCR, Bangladesh Technical Education Board, Houston Methodist Hospital, Investigational New Drug, Non-alcoholic fatty liver disease, BCR-ABL, MD, CML, R, Research and development, NASH, DUET, Pharmaceutical industry, Medical imaging, Cryptocurrency

FOSTER CITY, Calif., Nov. 14, 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 reported financial results for the quarter ended September 30, 2023 and provided corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $14.8 million for the quarter ended September 30, 2023, as compared with $12.2 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $18.4 million for the quarter ended September 30, 2023, as compared with $5.1 million for the quarter ended September 30, 2022.
  • Net Loss: Net loss was $29.8 million for the quarter ended September 30, 2023, as compared with $16.8 million for the quarter ended September 30, 2022.

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.

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
UDCA, Primary biliary cholangitis, Hypertension, ALP, Research and development, OCA, Obeticholic acid, Hepatology, ALT, Intercept Pharmaceuticals, Aes, Ursodeoxycholic acid, PBC, AASLD, Intercept, PPAR, FXR, Serum, Data analysis, Alanine transaminase, FDA, Liver, Alkaline phosphatase, Bezafibrate, GGT, Therapy, University, Development, Biomarker, Itch, Magnetic resonance, Safety, Pharmaceutical industry, Fused quartz, Medicine, Boston, Patient

These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).

Key Points: 
  • These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).
  • One severe TEAE (pruritus, OCA5/B100 IR) occurred in Study 214; no TEAEs led to study discontinuation in Study 214.
  • The Company expects to have the necessary data from the OCA-bezafibrate combination program to submit a request in 2023 for an End-of-Phase 2 meeting with the FDA.
  • These data include analyses from both Phase 2 studies, in addition to Phase 1 and preclinical data.

Novotech Releases In-Depth 2023 Global Clinical Trial Landscape Reports on Hemophilia and Primary Biliary Cholangitis

Retrieved on: 
Thursday, November 2, 2023
Female, Haemophilia B, United Kingdom, AAV, III, RNA, Cirrhosis, Ascending cholangitis, Health, Global Jurist of the Year Award, Research, PBC, Bile, FXR, Liver failure, NOX, Woman, Primary biliary cholangitis, Haemophilia A, Patient, Small RNA, Fine chemical, Pharmaceutical industry, Medical imaging, Haemophilia

BOSTON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities, today released the latest 2023 global clinical trial landscape reports on Primary Biliary Cholangitis (PBC) and Hemophilia .

Key Points: 
  • BOSTON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities, today released the latest 2023 global clinical trial landscape reports on Primary Biliary Cholangitis (PBC) and Hemophilia .
  • These reports provide up-to-date information on global clinical trial activity, shedding light on the regions that are witnessing the highest trial numbers and the reasons behind it.
  • As per the findings in the Primary Biliary Cholangitis – Global Clinical Trial Landscape report there have been approximately 140 active clinical trials focused on PBC since 2018.
  • In the Hemophilia Global Clinical Trial Landscape report, there has been a substantial increase in global clinical trials aimed at advancing hemophilia treatment since 2018.