Aramchol

Galmed Announces Grant of New Patent for the Combination of Aramchol with Resmetirom (MGL-3196, REZDIFFRA) for the Treatment of NASH and Liver Fibrosis

Retrieved on: 
Friday, March 15, 2024
Cirrhosis, BID, Aramchol, SCD1, Fibrosis, Patent, NASH, Liver, TEL

With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until September 2039.

Key Points: 
  • With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until September 2039.
  • Previously, Galmed reported results from the Open-Label part of its Phase 3 NASH study, which demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with fibrosis improvement.
  • Mr. Baharaff continued "It is clear today that NASH is a chronic condition with multiple liver pathologies.
  • By combining Aramchol and Resmetirom, two distinct and selective compounds with complementary mechanisms, we believe this will provide a perfect treatment for NASH."

Galmed Announces Issuance of New Composition of Matter Patent for Aramchol meglumine Salt

Retrieved on: 
Wednesday, February 8, 2023
NASH, Danny Galm, Patent, United States Patent and Trademark Office, Hebrew University of Jerusalem, Liver, Absorption, Liver disease, Fibrosis, Solubility, IP, Al-Quds, Meglumine, Pharmaceutical industry, Fine chemical, Aramchol

With the latest patent, Galmed is fortifying the IP protection of its lead compound, Aramchol, extending Aramchol's IP protection until end of 2038 (for its longest-term patent in US).

Key Points: 
  • With the latest patent, Galmed is fortifying the IP protection of its lead compound, Aramchol, extending Aramchol's IP protection until end of 2038 (for its longest-term patent in US).
  • Similar composition of matter patents have been granted in Canada, Europe, Australia, China, Hong-Kong, Korea, Israel, Japan and other territories for Aramchol salts.
  • Specifically, the invention provides the Aramchol amine salts and use thereof in medical treatment having advantageous physicochemical properties.
  • "This new patent which covers critical compositions of matter enhances our already robust patent portfolio, further strengthening and extending the potential commercial horizon for Aramchol," said Allen Baharaff, President and Chief Executive Officer of Galmed Pharmaceuticals.

Galmed Pharmaceuticals to Report Fourth Quarter and Year End 2021 Financial Results and Provide Business Update on Monday May 2

Retrieved on: 
Tuesday, April 26, 2022
Drug development, Fibrosis, Obesity, Population, NASH, Inflammation, Steatosis, Fast Track, Cirrhosis, FDA, Liver, Liver cancer, Cardiovascular disease, Non-alcoholic fatty liver disease, Dietary supplement, Aramchol

The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells.

Key Points: 
  • The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells.
  • Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.
  • NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.

Galmed Continues to Drive Innovation with Three New US Patents Granted for Aramchol and its Meglumine Salt

Retrieved on: 
Tuesday, January 11, 2022
Forward-looking statement, IP, Patient, Dysbiosis, United States Patent and Trademark Office, Cirrhosis, Liver, Clinical trial, EMA, SEC, TEL, COVID-19, Perception, ARMOR, Risk, CEO, NASH, Salt, Hebrew University of Jerusalem, USPTO, Patent, Drug development, Pathology, Fibrosis, NAFLD, Open-label trial, Annual report, FDA, Eleazar Sukenik, Physician, Terminology, Pharmaceutical industry, Galm, Aramchol

An additional patent grant protects the low dose composition of Aramchol salt until June 8, 2036.

Key Points: 
  • An additional patent grant protects the low dose composition of Aramchol salt until June 8, 2036.
  • With these latest patents, Galmed is strengthening and extending the IP protection of its lead compound, Aramchol, until December 2038.
  • The three new patents relate to:
    The grant of a US patent (US 11,197,870 B2, expiring October 20, 2037) claims the use of Aramchol or salts thereof (e.g.
  • As such, we are delighted that these newly granted patents help secure broad IP rights underpinning Aramchol and its salts.

Galmed announces positive results of Phase 1 study of Amilo-5MER

Retrieved on: 
Monday, January 10, 2022
Clinical trial, SEC, Safety, Plasma, TNBS, Drug development, Terminology, Polymerization, Risk, Cytokine release syndrome, DSS, Pharmacokinetics, TEL, Serum amyloid A, Liver, Fibrosis, Patient, Physician, Multiple sclerosis, Medication, Hebrew University of Jerusalem, Organic acid, IND, ARMOR, Ulcerative colitis, SAA, Serum, Female, Eleazar Sukenik, Part Two, Annual report, Forward-looking statement, Male, List of life sciences, Rheumatoid arthritis, CEO, Company, King's College London, NASH, IBD, COVID-19, FDA, School, BID, EMA, Perception, Imperial College London, Inflammation, Aramchol, Pharmaceutical industry, Galm

The safety, tolerability, and pharmacokinetics of single and multiple doses of Amilo-5MER were assessed in a first-in-human study in healthy subjects.The Phase I study was conducted in a single-center, using a double-blind, randomized, placebo-controlled design.

Key Points: 
  • The safety, tolerability, and pharmacokinetics of single and multiple doses of Amilo-5MER were assessed in a first-in-human study in healthy subjects.The Phase I study was conducted in a single-center, using a double-blind, randomized, placebo-controlled design.
  • Cohorts of 8 subjects were randomized to receive Amilo-5MER or placebo by subcutaneous injection in a ratio of 6:2.
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.
  • Our lead compound, Aramchol, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.

Galmed Pharmaceuticals Announces Publication in "The Journal of Autoimmunity" for its IND ready, Amilo-5MER, a specific anti-inflammatory compound

Retrieved on: 
Thursday, August 19, 2021
Hebrew University of Jerusalem, SAA, Liver, Fibroblast, Terminology, Journal, MS, EMA, Medical school, Inflammation, Monocyte, Fibrosis, TNF, ARMOR, Rheumatoid arthritis, SEC, Physician, Research, Journal of Autoimmunity, Risk, TEL, IBD, Perception, Polymerization, IL-6, RA, Forward-looking statement, Clinical trial, Pathology, Immunology, IND, Mall of America, Patient, CEO, Synovial fluid, Multiple sclerosis, Cytokine, NASH, FDA, Aramchol, Annual report, COVID-19, Drug development, Inflammatory bowel disease, Vaccine, Pharmaceutical industry

Amilo-5MER, is a five amino acid in a specific sequence that was originally isolated from synovial fluid of rheumatoid arthritis (RA) patients.

Key Points: 
  • Amilo-5MER, is a five amino acid in a specific sequence that was originally isolated from synovial fluid of rheumatoid arthritis (RA) patients.
  • The presumed MoA by which Amilo-5MER affects chronic inflammation is binding to SAA and preventing its ability to activate immune cells for pro inflammatory cytokine secretion.
  • Amilo-5MER suppresses the pro-inflammatory IL-6 release from SAA-activated cells, but not from non-activated cells providing selective anti inflammatory properties.
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.

Madrigal Pharmaceuticals Announces Participation at Two Upcoming Virtual Investor Conferences

Retrieved on: 
Tuesday, June 8, 2021
Medical specialties, Hepatitis, Anatomy, Clinical medicine, Steatohepatitis, Fatty liver disease, Non-alcoholic fatty liver disease, Liver disease, Aramchol, NNMT

WEST CONSHOHOCKEN, Pa., June 08, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical- stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today its management team will participate in two upcoming virtual investor conferences:

Key Points: 
  • WEST CONSHOHOCKEN, Pa., June 08, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical- stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today its management team will participate in two upcoming virtual investor conferences:
    Fireside chat at 9:40 a.m.
  • ET on Thursday, June 10, 2021
    Fireside chat at 3:30 pm ET on Wednesday, June 16, 2021
    The presentation will be webcast live and can be accessed in the Investor Relations section of the Madrigal website and will be available for replay for 90 days.
  • https://www.madrigalpharma.com/newsroom/presentations/
    Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need.
  • Madrigals lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)- selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients.

Madrigal Pharmaceuticals to Participate in UBS Global Healthcare Virtual Conference

Retrieved on: 
Friday, May 21, 2021
Medical specialties, Hepatitis, Anatomy, Clinical medicine, Steatohepatitis, Non-alcoholic fatty liver disease, Fatty liver disease, Liver disease, Melissa Palmer, Aramchol

b'WEST CONSHOHOCKEN, Pa., May 21, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today that members of its executive team, including Paul Friedman, M.D., Chief Executive Officer, Becky Taub, M.D., Chief Medical Officer and President of Research and Development, Remy Sukhija, Senior Vice President and Chief Commercial Officer and Alex Howarth, Chief Financial Officer, will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 4:00 pm ET.\nThe fireside chat will be webcast live and can be accessed in the Investor Relations section of the Madrigal website and will be available for replay for 90 days.\nMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need.

Key Points: 
  • b'WEST CONSHOHOCKEN, Pa., May 21, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today that members of its executive team, including Paul Friedman, M.D., Chief Executive Officer, Becky Taub, M.D., Chief Medical Officer and President of Research and Development, Remy Sukhija, Senior Vice President and Chief Commercial Officer and Alex Howarth, Chief Financial Officer, will participate in a fireside chat at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 4:00 pm ET.\nThe fireside chat will be webcast live and can be accessed in the Investor Relations section of the Madrigal website and will be available for replay for 90 days.\nMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need.
  • Madrigal\xe2\x80\x99s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-\xce\xb2 selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients.
  • For more information, visit www.madrigalpharma.com .\n'

Madrigal Pharmaceuticals to Present at RBC Capital Markets Virtual 2021 Global Healthcare Conference on Wednesday, May 19, 2021 at 8:00 a.m. ET

Retrieved on: 
Tuesday, May 18, 2021
Medical specialties, Hepatitis, Anatomy, Clinical medicine, Steatohepatitis, Fatty liver disease, Non-alcoholic fatty liver disease, Liver disease, Melissa Palmer, Aramchol

b'WEST CONSHOHOCKEN, Pa., May 18, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today that members of its executive team, including Paul Friedman, M.D., Chief Executive Officer, Becky Taub, M.D., Chief Medical Officer and President of Research and Development, Remy Sukhija, Senior Vice President and Chief Commercial Officer and Alex Howarth, Chief Financial Officer, will present at the RBC Capital Markets Virtual 2021 Global Healthcare Conference on Wednesday, May 19, 2021 at 8:00 a.m. ET.\nThe presentation will be webcast live and can be accessed in the Investor Relations section of the Madrigal website and will be available for replay for 90 days.\nMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need.

Key Points: 
  • b'WEST CONSHOHOCKEN, Pa., May 18, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need such as non-alcoholic steatohepatitis (NASH), announced today that members of its executive team, including Paul Friedman, M.D., Chief Executive Officer, Becky Taub, M.D., Chief Medical Officer and President of Research and Development, Remy Sukhija, Senior Vice President and Chief Commercial Officer and Alex Howarth, Chief Financial Officer, will present at the RBC Capital Markets Virtual 2021 Global Healthcare Conference on Wednesday, May 19, 2021 at 8:00 a.m. ET.\nThe presentation will be webcast live and can be accessed in the Investor Relations section of the Madrigal website and will be available for replay for 90 days.\nMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need.
  • Madrigal\xe2\x80\x99s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-\xce\xb2 selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients.
  • For more information, visit www.madrigalpharma.com .\n'

Galmed Pharmaceuticals Announces Upcoming Publication in JHEP Reports of New Data Supporting Aramchol's Novel Anti-Fibrotic Mechanism of Action

Retrieved on: 
Tuesday, January 26, 2021
Medical specialties, Anatomy, Aramchol, Hepatic stellate cell, Liver, Hepatology, Pirfenidone, Fatty liver disease

The paper is expected to be published in the JHEP Reports on January 28, 2021.

Key Points: 
  • The paper is expected to be published in the JHEP Reports on January 28, 2021.
  • Data further support Aramchol's role in fibrosis reversal, including the potential antifibrotic activity in the ongoing Phase 3 ARMOR study in patients with NASH and fibrosis.
  • "Our findings establish a direct antifibrotic effect of Aramchol on hepatic stellate cells, the principal collagen-producing cell in liver through its inhibition of SCD1.
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.