FXR

Organovo Data Presented at Digestive Disease Week (DDW2024) Demonstrating Potential for FXR314 as Combination Therapy with Tofacitinib for Inflammatory Bowel Disease

Retrieved on: 
tisdag, maj 21, 2024
3D, IBD, Patient, Colitis, Research and development, SAN, FXR, JAK, Ulcerative colitis, Poster, Fibrosis, D.C, Inflammation, Inflammatory bowel disease, Pharmaceutical industry

The poster, titled, “Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease” was presented on Saturday May 18, 2024, in the session “Translational application of intestinal stem cells and organoid models”.

Key Points: 
  • The poster, titled, “Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease” was presented on Saturday May 18, 2024, in the session “Translational application of intestinal stem cells and organoid models”.
  • Key findings showed that FXR314 and tofacitinib improved various measures of intestinal barrier function, inflammation, and fibrosis at optimal concentrations.
  • In addition, FXR314 alone improved measures of colon health and colon histopathology similarly to approved IBD therapies tofacitinib and IL-12/23 antagonist.
  • “These results further bolster our belief in the potential of FXR314 in combination therapy, and such data will be beneficial both in terms of potential combination development and also when used in monotherapy.

Organovo to Present Data on FXR314 at Digestive Diseases Week (DDW2024)

Retrieved on: 
tisdag, maj 14, 2024
IBD, FXR, D.C, SAN, Inflammatory bowel disease, Ulcerative colitis, Poster, Pharmaceutical industry

SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces it will be presenting data on the Company’s lead clinical-stage drug, FXR314 during DDW2024, which is being held in Washington, D.C. May 18-21, 2024.

Key Points: 
  • SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces it will be presenting data on the Company’s lead clinical-stage drug, FXR314 during DDW2024, which is being held in Washington, D.C. May 18-21, 2024.
  • The poster, titled, “Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease,” will be presented on Saturday May 18, 2024 at 12:30 EDT in the session “Translational application of intestinal stem cells and organoid models.”
    “We look forward to connecting with prescribers and potential partners during DDW2024, which is one of the largest gatherings of gastrointestinal physicians in the United States.
  • We look forward to sharing our first set of findings on the combination therapy potential of FXR314, which, complementing its monotherapy promise, adds to its attractiveness for partnering,” stated Keith Murphy, Organovo’s Executive Chairman.

Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to Placebo

Retrieved on: 
måndag, april 15, 2024
Itch, TE, MASH, MRE, Clinical trial, Incidence, Patient, Clinical, Apolipoprotein, Safety, FXR, Biopsy, Dietary supplement

Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo.

Key Points: 
  • Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo.
  • “The key findings of this study are that once daily oral FXR314 demonstrated statistically significant liver fat reduction and excellent tolerability.
  • A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo.
  • The Company expects that detailed findings of this study (Clinical trial registry NCT047773964) will be presented at an upcoming conference.

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: 
torsdag, januari 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: 
onsdag, januari 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: 
onsdag, januari 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: 
tisdag, januari 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: 
onsdag, januari 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: 
onsdag, 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: 
tisdag, 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.