A Proof of Concept, Prospective, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients With Primary Sclerosing Cholangitis

The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis

Start Date01 Jun 2025

Sponsor / Collaborator

Galmed Pharmaceuticals Ltd.

[+1]

NCT06502561 / Not yet recruitingPhase 1

A Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers

This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers

Start Date01 Oct 2024

Sponsor / Collaborator

Galmed Pharmaceuticals Ltd.

NCT05874336 / CompletedPhase 1

An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability of Aramchol and to Determine the Mass Balance Recovery, Metabolite Profile and Metabolite Identification to Healthy Male Subjects

A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects

Start Date17 Jun 2020

Sponsor / Collaborator

Galmed Pharmaceuticals Ltd.

[+1]

100 Clinical Results associated with Icomidocholic acid

100 Translational Medicine associated with Icomidocholic acid

100 Patents (Medical) associated with Icomidocholic acid

Literatures (Medical) associated with Icomidocholic acid

01 Mar 2021·Pharmacotherapy: The Journal of Human Pharmacology and Drug TherapyQ3 · MEDICINE

Emerging therapies for the treatment of nonalcoholic steatohepatitis: A systematic review

Q3 · MEDICINE

Review

Author: DellaVecchia, Matthew J. ; Ruble, Melissa ; Bolson, Anthony ; Guirguis, Erenie ; Grace, Yasmin

AbstractTo describe the mechanism, efficacy, and safety of novel agents that have reached phase 3 clinical trials for the treatment of biopsy‐proven nonalcoholic steatohepatitis (NASH). A literature search was conducted using the PRISMA guidelines of MEDLINE databases (1990 to October 2020) with the following MeSH terms: NASH, nonalcoholic liver disease, fatty liver, liver diseases, steatohepatitis, liver fibrosis; combined with obeticholic acid, FXR agonist, cenicriviroc, CCR5 receptor antagonist, elafibranor, PPAR, selonsertib, ASK‐1 inhibitor, resmetirom, THR‐β receptor, arachidyl amido cholanoic acid (Aramchol™), and SCD‐1 modulator. Results were verified via clinicaltrials.gov, Google Scholar, and Google. Articles were included if the medications of interest had ongoing or completed phase 3 trials in biopsy‐proven NASH with outcomes directly related to NASH resolution. Eleven studies were identified involving obeticholic acid (OCA), elafibranor, cenicriviroc, Aramchol, and resmetirom. Two agents have reported data from phase 3 trials: OCA and elafibranor. OCA demonstrated safety and efficacy in NASH with a primary end point of improvement or NASH resolution; a new drug approval has been submitted. Elafibranor failed to show efficacy in NASH in the preliminary report from the RESOLVE‐IT trial; however, the study is being extended to reassess outcomes. The remaining agents demonstrated positive results in phase 2b studies and have initiated phase 3 trials. With projections for increased prevalence of patients with NASH and the current lack of treatment options, novel agents with targeted mechanisms could potentially change the treatment landscape. The manufacturer of OCA is first to submit a new drug application for the treatment of NASH. These novel agents may fill a pharmacotherapy gap in patients with NASH and possibly prevent progression to advanced liver disease.

14 Sep 2020·World Journal of GastroenterologyQ3 · MEDICINE

Arachidyl amido cholanoic acid improves liver glucose and lipid homeostasis in nonalcoholic steatohepatitis via AMPK and mTOR regulation

Q3 · MEDICINE

Article

Author: Lopitz-Otsoa, Fernando ; Fernández-Ramos, David ; Mato, José M ; Tsvirkun, Darya ; Goni, Felix M ; Lu, Shelly C ; Serrano-Macia, Marina ; Iruarrizaga-Lejarreta, Marta ; Pagano, Martina ; Hayardeny, Liat ; Azkargorta, Mikel ; Alonso, Cristina ; Elortza, Felix ; Bilbao, Jon ; Martínez-Chantar, María Luz ; Mosca, Laura ; van Liempd, Sebastiaan Martijn ; Delacruz-Villar, Laura ; Sot, Jesús ; Bizkarguenaga, Maider

BACKGROUNDArachidyl amido cholanoic acid (Aramchol) is a potent downregulator of hepatic stearoyl-CoA desaturase 1 (SCD1) protein expression that reduces liver triglycerides and fibrosis in animal models of steatohepatitis. In a phase IIb clinical trial in patients with nonalcoholic steatohepatitis (NASH), 52 wk of treatment with Aramchol reduced blood levels of glycated hemoglobin A1c, an indicator of glycemic control.AIMTo assess lipid and glucose metabolism in mouse hepatocytes and in a NASH mouse model [induced with a 0.1% methionine and choline deficient diet (0.1MCD)] after treatment with Aramchol.METHODSIsolated primary mouse hepatocytes were incubated with 20 μmol/L Aramchol or vehicle for 48 h. Subsequently, analyses were performed including Western blot, proteomics by mass spectrometry, and fluxomic analysis with ¹³C-uniformly labeled glucose. For the in vivo part of the study, male C57BL/6J mice were randomly fed a control or 0.1MCD for 4 wk and received 1 or 5 mg/kg/d Aramchol or vehicle by intragastric gavage for the last 2 wk. Liver metabolomics were assessed using ultra-high-performance liquid chromatography-time of flight-MS for the determination of glucose metabolism-related metabolites.RESULTSCombination of proteomics and Western blot analyses showed increased AMPK activity while the activity of nutrient sensor mTORC1 was decreased by Aramchol in hepatocytes. This translated into changes in the content of their downstream targets including proteins involved in fatty acid (FA) synthesis and oxidation [P-ACCα/β(S79), SCD1, CPT1A/B, HADHA, and HADHB], oxidative phosphorylation (NDUFA9, NDUFB11, NDUFS1, NDUFV1, ETFDH, and UQCRC2), tricarboxylic acid (TCA) cycle (MDH2, SUCLA2, and SUCLG2), and ribosome (P-p70S6K[T389] and P-S6[S235/S236]). Flux experiments with ¹³C-uniformely labeled glucose showed that TCA cycle cataplerosis was reduced by Aramchol in hepatocytes, as indicated by the increase in the number of rounds that malate remained in the TCA cycle. Finally, liver metabolomic analysis showed that glucose homeostasis was improved by Aramchol in 0.1MCD fed mice in a dose-dependent manner, showing normalization of glucose, G6P, F6P, UDP-glucose, and Rbl5P/Xyl5P.CONCLUSIONAramchol exerts its effect on glucose and lipid metabolism in NASH through activation of AMPK and inhibition of mTORC1, which in turn activate FA β-oxidation and oxidative phosphorylation.

01 Jan 2020·Zeitschrift für GastroenterologieQ4 · MEDICINE

Welches (ist das richtige) Target bei nichtalkoholischer Fettleber (NAFLD)

Q4 · MEDICINE

Review

Author: Galle, Peter R. ; Schattenberg, Jörn M. ; Huber, Yvonne

News (Medical) associated with Icomidocholic acid

19 Sep 2024

·www.prnewswire.com

Galmed Announces an Expansion of its Activities to Cancer and major Cardiometabolic Diseases

Aramchol is the most clinically advanced, first-in-class, Stearoyl-CoA desaturase1 (SCD1) oral inhibitor, demonstrating in Ph2 and Ph3 (open label part) an excellent safety profile with metabolic and anti-fibrotic effects. Galmed raised an aggregate of $7.5 million in warrant exercises and drawdowns on its recently adopted equity line TEL AVIV, Israel, Sept. 19, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for fibroinflammatory indications announced today that based on the recently published results from the Open-Label part of its Phase 3 NASH study, new scientific publications on the role of SCD1 as a critical metabolic signaling hub as well as an extended cash runway, it plans to broaden its drug development activities. The planned expansion consists of two additional programs over the next two years. One program aims to identify novel Aramchol-based drug combinations to overcome resistance to standard-of-care oncological treatments for patients with advanced colorectal and hepatic cancers. Another program aims to unravel new mechanisms of action that will allow the development of a novel Aramchol-based drug combination targeting cardiac fibrosis, or scarring of the heart, which occurs in many cardiovascular diseases that can lead to heart dysfunction and failure. The Company plans on releasing new data from in-vitro and ex-vivo studies in these programs during the fourth quarter of 2024. Recent scientific publications reveal that: SCD1 inhibition emerges as a novel therapeutic strategy for clinically important cardiometabolic diseases which affect more than 60 million people in the United States alone. The combination of SCD1 inhibitor with standard-of-care oncology agents has the potential of the prevention of drug resistance thus ameliorating the prognosis of patients with hepatoma (hepatocellular carcinoma, HCC), colorectal cancer and glioma (GBM). The newly discovered link between lipid metabolism and synucleinopathies (Parkinson disease and some forms of dementia) provides validation of SCD inhibition as a neuroprotective treatment. Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "The conditions Galmed plans to focus upon in the coming years are major public health problems impacting millions of people worldwide and posing huge financial burden on health providers. SCD1 is a key enzyme that critically regulates many physiological processes, thereby promoting the progression of cardiovascular, cancer and neurodegenerative diseases. We are leveraging on two decades of development of the most clinically advanced SCD1 inhibitor (Aramchol) to date as we broaden our drug development activities. Recent scientific breakthroughs identifying the role of SCD1 as a "master-switch" in lipid metabolism together with our recent infusion of cash, encourage us to expand from liver diseases to major cardiometabolic and cancer indications in dire need of new therapies. In this research, Galmed is collaborating with both leading academia and industry, employing cutting-edge drug development methodologies like AI data mining and proprietary "organ-on-a-chip" systems to accelerate our development processes." About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused on developing Aramchol for the treatment of liver disease and have been developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibroinflammatory and oncological indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo5MER, a 5 amino acid synthetic peptide. Forward-Looking Statements: Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believes or anticipate will or may occur in the future. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the timing and cost of any pre-clinical or clinical trial, for our product candidates; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol or any other product candidate; our expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH, in patients or any other targeted indication; third-party payor reimbursement for Aramchol or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; our ability to maintain the listing of our ordinary share on The Nasdaq Capital Market; and our expectations regarding licensing, acquisitions and strategic operations. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 4, 2024 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. Logo: SOURCE Galmed Pharmaceuticals Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2

21 Mar 2024

·www.prnewswire.com

MIRA Pharmaceuticals Welcomes Dr. Itzchak Angel, former Head of Pharmacology at Synthelabo, as Chief Scientific Advisor

A seasoned pharmaceutical industry executive with over 40 years at the forefront of innovation, including at Synthelabo (acquired by Sanofi-Aventis), Dr. Angel aims to propel MIRA Pharmaceuticals' mission to tackle unmet needs in neurologic and neuropsychiatric disorders MIAMI, March 21, 2024 /PRNewswire/ -- MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on the development of novel treatments for neurologic and neuropsychiatric disorders, proudly announces the appointment of distinguished pharmaceutical executive Dr. Itzchak Angel as its new Chief Scientific Advisor. Dr. Angel brings over 40 years of preclinical, clinical and regulatory acumen to MIRA. He has significantly contributed to the research, development and regulatory approval of groundbreaking medications over his remarkable career. Notably, at Synthelabo (later acquired by Sanofi-Aventis), Dr. Angel played a pivotal role in advancing several drugs, including Litoxetine for depression and Deriglidole for Type-II diabetes, from conception to Investigational New Drug (IND) applications and clinical trials. Additionally, his activities contributed to the development and marketing of Mizollen (mizolastine), Xatral (alfuzosin) and Ambien (zolpidem). Beyond his tenure at Synthelabo, Dr. Angel has made significant advancements in the pharmaceutical industry, including impactful work at several companies, such as Teva, where he was an external consultant in strategic drug development and innovation. He has also founded and served as an officer and director of several pharma start-ups. He was Vice President for Research and Development at D-Pharm Biopharmaceuticals, where he advanced DP-VPA into the human trials for epilepsy and bi-polar disorders (later licensed to Shire Pharmaceuticals) and the chelator DP-b99 for stroke (which advanced to phase-III clinical trials). Dr Angel also served as President and Chief Executive Officer of stem-cell company Accellta; Vice President for Research and Development at Proteologics Ltd and at Galmed Pharmaceuticals (where he advanced Aramchol through an IND to phase-II clinical trials); Head of Discovery and Research and Development Concenter Biopharma (where he advanced Zygosid-50 towards clinical trials) and others. His experience extends through various therapeutic areas and has led to the successful research and development of several drugs, highlighting his vast expertise and ability to bring critical treatments through the regulatory process and ultimately to market. Dr. Angel's extensive background in drug development, from preclinical research through clinical trials and market introduction, positions him well to contribute to MIRA's scientific endeavors. His leadership is expected to accelerate MIRA's research and development pipeline, particularly in advancing its flagship compounds, including the innovative Ketamir-2 for treatment-resistant depression. "We are truly honored to have Dr. Angel on our team," stated Erez Aminov, Chairman & CEO of MIRA. "His distinguished career across the pharmaceutical industry, from start-ups to big pharma, his exceptional scientific skills and his dedication to pharmaceutical innovation will help propel our promising pre-clinical drug candidates forward. His expertise will be invaluable as we move our product candidates towards INDs and through the clinical trial and regulatory approval process and also as we seek to expand our product candidate portfolio." Dr. Angel stated, "I am thrilled to contribute to MIRA's pioneering efforts in addressing the challenges in neurologic and neuropsychiatric disorders. I look forward to applying my experience and insights to help advance MIRA." About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. The Company's novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. MIRA also holds the exclusive U.S., Canadian and Mexican rights for Ketamir-2, a novel, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about the Company is available at: . Cautionary Note Regarding Forward-Looking Statements This press release and the statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "Aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding Ketamir-2's potential in treating certain mental health conditions. Any forward-looking statements in this press release are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results (including the anticipated benefits Dr. Angel's services to the Company) to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in its registration statement on Form S-1 and other SEC filings, which are on file with the SEC at and the Company's website at . The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. SOURCE MIRA Pharmaceuticals, Inc.

Executive ChangeAcquisition

15 Mar 2024

·www.prnewswire.com

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

TEL AVIV, Israel, March 15, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases announced today the grant of a European patent related to the use of a combination of Aramchol and Resmetirom (MGL-3196, REZDIFFRA) for the treatment of NASH/MASH and liver fibrosis. The patent was granted in France, Germany, Italy, the Netherlands and the United Kingdom and the approval of the patent in the United States and other countries is pending. 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. Galmed has long believed that the optimum treatment for NASH/MASH will be combination therapy. Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD1) in hepatic stellate cells, resulting in a direct effect on fibrogenesis. Aramchol's unique mechanism of action differs from others in its competitive landscape, positioning it to work as a potent anti-fibrotic compound alongside effective treatments in both approved and pre-approval stages. Allen Baharaff, CEO and President of Galmed Pharmaceuticals mentioned that "this new patent for the combination of Aramchol and Resmetirom reflects the same spirit of earlier patents which were granted to Galmed by the United States Patent and Trademark Office (USPTO) for the treatment for hepatic fibrosis." Mr. Baharaff continued "It is clear today that NASH is a chronic condition with multiple liver pathologies. Among all pathologies, excessive liver fat, high glycemic index and fibrosis are major treatment challenges. By combining Aramchol and Resmetirom, two distinct and selective compounds with complementary mechanisms, we believe this will provide a perfect treatment for NASH." About Galmed Pharmaceuticals Ltd. We are a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. We have focused almost exclusively on developing Aramchol for the treatment of NASH and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide. Forward-Looking Statements: Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believesor anticipate will or may occur in the future. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the timing and cost of any pre-clinical or clinical trial, for our product candidates; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol or any other product candidate; our expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH, in patients or any other targeted indication; third-party payor reimbursement for Aramchol or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; our ability to maintain the listing of our ordinary share on The Nasdaq Capital Market; and our expectations regarding licensing, acquisitions and strategic operations. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. SOURCE Galmed Pharmaceuticals Ltd.

Clinical ResultPhase 3

100 Deals associated with Icomidocholic acid

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis	Phase 3	IL	Galmed Pharmaceuticals Ltd.	26 Feb 2024
Nonalcoholic Steatohepatitis	Phase 3	US	SAMIL PHARMACEUTICAL Co., Ltd.	-
Cholangitis, Sclerosing	Phase 2	US	Galmed Pharmaceuticals Ltd.	01 Jun 2025
HIV Infections	Phase 1	US	University of California San Diego	01 Jan 2016
Lipodystrophy	Phase 1	US	University of California San Diego	01 Jan 2016
Metabolic dysfunction-associated steatotic liver disease	Phase 1	US	University of California San Diego	01 Jan 2016
Metabolic Syndrome	Phase 1	IL	Galmed Medical Research Ltd.	01 Nov 2010
Gallstones	Discovery	IL	Galmed Pharmaceuticals Ltd.	01 Oct 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02279524 (ARREST, Pubmed \| Nat Med) Manual	Phase 2	Nonalcoholic Steatohepatitis	247	Aramchol 600mg	(xibbjokbwl) = xjmokhxhzs gkgmpdnogy (fafdkwmiww, -6.4 to 0.2) View more	Positive	01 Oct 2021
				Placebo	(ddpfhkvnzg) = bdrfjpxhyd feciqrlbdw (asdyctqmoa ) View more
NCT02279524 (ARREST \| Aramchol_005, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	247	Aramchol (Aramchol 600mg)	nkmaghccnl(ciqnmrwhti) = vtucmmmvxw degkyqysdl (epyzfegidd, sprydxgsky - kuggvqwxpq) View more	-	14 Jul 2021
				Aramchol (Aramchol 400mg)	nkmaghccnl(ciqnmrwhti) = mfgovrrhye degkyqysdl (epyzfegidd, kjvejqmijc - ipoxgwefoz) View more
NCT02684591 (ARRIVE, Pubmed \| Hepatology) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	50	Aramchol	(vfpqnhtasl) = lmwmpkmzvn qiwupodlam (mjoekeukra ) View more	Negative	01 Nov 2019
				Placebo	(vfpqnhtasl) = eoazvosmqk qiwupodlam (mjoekeukra ) View more
NCT02684591 (ARRIVE \| ARRIVE Trial, CTgov)	Phase 2	Lipodystrophy \| HIV Infections \| Metabolic dysfunction-associated steatotic liver disease	50	Aramchol (Aramchol 600 mg Orally Daily)	hbntowahnl(uyxkwhlmav) = rpmyzpsroo qzlkmbrcfx (qwsbhbuwps, lozgbjehik - dvjpseomlh) View more	-	21 Aug 2019
				Placebo (Placebo)	hbntowahnl(uyxkwhlmav) = mgxsrguqwj qzlkmbrcfx (qwsbhbuwps, oefswsfngg - cmhlyzways) View more

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