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

/ Active, not 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 Date15 Feb 2025

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 2025·HEPATOLOGY

Aramchol improves hepatic fibrosis in metabolic dysfunction–associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology

Article

Author: Eyal, Eli ; Cummings, Oscar W ; Petitjean, Mathieu ; Chen, Li ; Friedman, Scott L ; Yilmaz, Yusuf ; Lazas, Don ; Kadosh, Shaul ; Sanyal, Arun J ; Behling, Cynthia ; Gilgun-Sherki, Yossi ; Lackner, Caroline ; Ratziu, Vlad ; Gorfine, Tali

Background and Aims::

Antifibrotic trials rely on conventional pathology despite recognized limitations. We compared single-fiber digital image analysis with conventional pathology to quantify the antifibrotic effect of Aramchol, a stearoyl-CoA desaturase 1 inhibitor in development for metabolic dysfunction–associated steatohepatitis.

Approach and Results::

Fifty-one patients with metabolic dysfunction–associated steatohepatitis enrolled in the open-label part of the ARMOR trial received Aramchol 300 mg BID and had paired pre-post treatment liver biopsies scored by consensus among 3 hepatopathologists, and separately assessed by a digital image analysis platform (PharmaNest) that generates a continuous phenotypic Fibrosis Composite Severity (Ph-FCS) score. Fibrosis improvement was defined as: ≥1 NASH Clinical Research Network (NASH-CRN) stage reduction; “improved” by ranked pair assessment; reduction in Ph-FCS (“any” for ≥0.3 absolute reduction and “substantial” for ≥25% relative reduction). Fibrosis improved in 31% of patients (NASH-CRN), 51% (ranked pair assessment), 74.5% (any Ph-FCS reduction), and 41% (substantial Ph-FCS reduction). Most patients with stable fibrosis by NASH-CRN or ranked pair assessment had a Ph-FCS reduction (a third with substantial reduction). Fibrosis improvement increased with treatment duration: 25% for <48 weeks versus 39% for ≥48 weeks by NASH-CRN; 43% versus 61% by ranked pair assessment, mean Ph-FCS reduction −0.54 (SD: 1.22) versus −1.72 (SD: 1.02); Ph-FCS reduction (any in 54% vs. 100%, substantial in 21% vs. 65%). The antifibrotic effect of Aramchol was corroborated by reductions in liver stiffness, Pro-C3, and enhanced liver fibrosis. Changes in Ph-FCS were positively correlated with changes in liver stiffness.

Conclusions::

Continuous fibrosis scores generated in antifibrotic trials by digital image analysis quantify antifibrotic effects with greater sensitivity and a larger dynamic range than conventional pathology.

31 Jul 2024·Journal of Clinical and Translational Hepatology

Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease

Review

Author: Fan, Jian-Gao ; Hu, Ye ; Liu, Yu-Dong ; Sun, Chao ; Chen, Ying

Given the global prevalence and rising incidence of metabolic dysfunction-associated steatotic liver disease (MASLD), the absence of licensed medications is striking. A deeper understanding of the heterogeneous nature of MASLD has recently contributed to the discovery of novel groups of agents and the potential repurposing of currently available medications. MASLD therapies center on four major pathways. Considering the close relationship between MASLD and type 2 diabetes, the first approach involves antidiabetic medications, including incretins, thiazolidinedione insulin sensitizers, and sodium-glucose cotransporter 2 inhibitors. The second approach targets hepatic lipid accumulation and the resultant metabolic stress. Agents in this group include peroxisome proliferator-activated receptor agonists (e.g., pioglitazone, elafibranor, saroglitazar), bile acid-farnesoid X receptor axis regulators (obeticholic acid), de novo lipogenesis inhibitors (aramchol, NDI-010976), and fibroblast growth factor 21/19 analogs. The third approach focuses on targeting oxidative stress, inflammation, and fibrosis. Agents in this group include antioxidants (vitamin E), tumor necrosis factor α pathway regulators (emricasan, pentoxifylline, ZSP1601), and immune modulators (cenicriviroc, belapectin). The final group targets the gut (IMM-124e, solithromycin). Combination therapies targeting different pathogenetic pathways may provide an alternative to MASLD treatment with higher efficacy and fewer side effects. This review aimed to provide an update on these medications.

01 Mar 2024·Journal of crop science and biotechnology

Comparison of metabolites between brown rice and germinated brown rice in a Korean weedy rice germplasm

Author: Cho, Ei Ei ; Chung, Nam-Jin

Weedy rice is a semi-wild species that has survived for a very long time in rice fields, so its seeds could contain more functional substances than cultivated rice.Addnl., during the process of seed germination, some physiol. active substances that were not present in the seed are newly synthesized, so the functional compounds of germinated seeds could be improved over those of untreated raw seeds.From this perspective, we evaluated metabolite compounds of the brown rice (BR) and germinated brown rice (GBR) of WD3 compared with a cultivated rice, Sindongjin (SDJ).WD3 is a weedy rice selected for antioxidant activity from 199 accessions of Korea-native weedy rice germplasm (Cho et al., J Crop Sci 63:219-228, 2018).Metabolites were measured by using UPLC coupled with tandem mass spectrometry.Pareto scaling method prior to statistical and chemometric anal. were used for data acquisition and processing for metabolize compoundsOPLS-DA was conducted to develop discriminatory models.To support the potential biomarkers identification and further understanding of this study, the information on compounds was queried on the Chemspider web page.The obvious separation of metabolites between WD3 and SDJ in both BR and GBR were observed, in which a total of 103 compounds were detected.Among them, 52 compounds were known and 51 compounds were unknown.In the known compounds, long aliphatic chains were commonly found and the others were steroids, alkaloids, polyols, peptide and aromatic acid.Some metabolites such as 3 alkaloid compounds, 2 steroids, 1 aromatic acid and 15 long aliphatic chains were significantly increased after germination in WD3 seeds.Among them, the content of C45H84NO7P was increased by more than 1,000,000 times after germination.These compounds found in the GBR of WD3 might also be correlated to the nutritionally qualities claimed to be responsible for the advantageous properties of GBR.

News (Medical) associated with Icomidocholic acid

10 Apr 2025

·www.prnewswire.com

Galmed Announces Positive Part 1 Results from the AM-001 Study of Aramchol Meglumine, an Enhanced Formulation of the Most Clinically Advanced SCD1 Inhibitor

– AM-001 Study represents a pivotal milestone in Galmed's transition to Aramchol Meglumine, an improved formulation of its lead compound in advanced clinical development – Aramchol Meglumine, a New Chemical Entity (NCE) protected by patents until 2035, is being developed both as a standalone agent and in novel drug combinations for multiple indications influenced by fatty acid metabolism – Initial findings suggest that the new Aramchol Meglumine formulation offers higher bioavailability than Aramchol free acid and that a once-daily, oral 200 mg dose is likely to be optimal for future trials, supporting improved patient compliance and potentially lowering manufacturing costs TEL AVIV, Israel, April 10, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, today announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study of Aramchol Meglumine. Galmed has successfully advanced Aramchol acid through six clinical trials (up to Ph3) enrolling 661 subjects, establishing both its overall safety and its efficacy in treating NASH (MASH). The N-methylglucamine (meglumine) salt of Aramchol exhibits notable advantages over Aramchol acid, including enhanced solubility, absorption, and systemic exposure, translating to higher bioavailability. In recognition of these benefits, Aramchol Meglumine received NCE patent protection extending until 2035. Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumine under a new IND, leveraging cross-reference to the substantial preclinical and clinical data amassed in recent years for Aramchol. The only requirement for this transition was a bioavailability study to compare the two formulations. The AM-001 study was conducted in response to that FDA request and is also designed to help identify the doses best suited for advancing Aramchol Meglumine into Phase 2 studies. It consists of two parts, comparing single doses of Aramchol acid and Aramchol Meglumine in healthy volunteers. Part 2 of the study is anticipated to conclude in the second half of 2025. In Part 1 of AM-001, preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets. Based on these outcomes, 200 mg once daily appears to be the optimal dose for subsequent clinical trials. This once-daily regimen not only simplifies patient adherence (moving from twice-daily to once-daily) but is also expected to reduce the overall cost of goods. "Aramchol is the most advanced down regulator of SCD-1 (Stearoyl – CoA desaturase) in clinical development. Inhibition of SCD-1 has been recently investigated in multiple indications, re-emphasizing its metabolic master switch potential and importance in multiple organs and functions. We expect that the long patent runway of Aramchol Meglumine will allow us to develop the full therapeutical potential of the drug in the planned expansion in cardiometabolic diseases and gastrointestinal cancers we recently announced," said Allen Baharaff, President and CEO of Galmed Pharmaceuticals. These latest Part 1 data reinforce Galmed's commitment to accelerating Aramchol Meglumine's clinical program. As seen with other biopharmaceutical companies that have successfully introduced improved formulations—often resulting in increased market interest—Galmed believes that Aramchol Meglumine's enhanced bioavailability, once-daily dosing, and robust patent protection position the Company favorably for continued growth. By building on its strong clinical foundation, Galmed aims to deliver innovative therapies for patients with significant unmet medical needs, while responsibly driving value for stakeholders. About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development. 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 product development efforts, business, financial condition, results of operations, strategies or prospects, including the timing of completion of the AM 001 study, 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 development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; 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; 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; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. 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, 2024 filed with the SEC on April 2, 2025 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

Clinical ResultPhase 1Drug Approval

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

100 Deals associated with Icomidocholic acid

External Link

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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	Israel	Galmed Pharmaceuticals Ltd.	26 Feb 2024
Nonalcoholic Steatohepatitis	Phase 3	United States	Galmed Research & Development Ltd.	23 Sep 2019
Cholangitis, Sclerosing	Phase 2	United States	Galmed Pharmaceuticals Ltd.	01 Jun 2025
HIV Infections	Phase 2	United States	University of California San Diego	01 Jan 2016
Lipodystrophy	Phase 2	United States	University of California San Diego	01 Jan 2016
Metabolic dysfunction-associated steatotic liver disease	Phase 2	United States	University of California San Diego	01 Jan 2016
Gallstones	Phase 2	Israel	Galmed Pharmaceuticals Ltd.	01 Oct 2014
Metabolic Syndrome	Phase 2	Israel	Galmed Medical Research Ltd.	01 Nov 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AM-001 (PRNewswire) Manual	Phase 1	-	-	Aramchol Meglumine	rtxlfwxdgi(zbybvyedys) = preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets. wigdzsywfu (drdlzokqpo )	Positive	10 Apr 2025
				Aramchol free acid
NCT04104321 (ARMOR, CTgov)	Phase 3	Nonalcoholic Steatohepatitis	157	Aramchol (Aramchol)	ojjoaseehw = jtnhziizuv fqagvvplyx (ssialmxxal, glerwjqwid - bcgjccmmtc) View more	-	16 Dec 2024
				Aramchol (Patients Randomized to the OL Part of the ARMOR Study)	nkohulwqhr(huxcitadsf) = kknkgmirnj nbymsfoiip (qxglvhcwhv, uhutmoxxse - xxmvuqtbfh) View more
NCT04480827 (CTgov)	Phase 1	Hepatic Insufficiency	57	Aramchol free acid tablet 600mg, single dose (Part 1: Mild Hepatic Impairment (Cohort A))	vwrvtlxjtd(axqoclbeio) = whqwdusbby snvpkwyzda (izeftjpokn, 138.29) View more	-	14 Aug 2024
				Aramchol free acid tablet 600mg, single dose (Part 1: Moderate Hepatic Impairment (Cohort B))	vwrvtlxjtd(axqoclbeio) = fxvajwzrwv snvpkwyzda (izeftjpokn, 154.13) View more
NCT04104321 (ARMOR, EASL2022)	Phase 3	Fibrosis ALT \| AST \| Fib-4 ... View more	150	Aramchol 300 mg BID	vupbmwsmfq(tdzbejmjto) = vnxltwuozx zokjkzeskq (jyjvroivwi )	Positive	24 Jun 2022
ARMOR STUDY (NASH_TAG2022)	Phase 3	Fibrosis ALT \| AST \| Fib-4 ... View more	150	Aramchol 300mg BID	jvpmmvtxqh(arzvsamqww) = hjjswnqhjw asgetvolxf (ektqkbxnwd )	Positive	06 Jan 2022
				Placebo	jvpmmvtxqh(arzvsamqww) = vltdgudmtm asgetvolxf (ektqkbxnwd )
NCT02279524 (ARREST, Pubmed \| Nat Med) Manual	Phase 2	Nonalcoholic Steatohepatitis	247	Aramchol 600mg	dysxtcckqz(ouovewnvll) = gjfpakfsjl qybrdggofa (qevymhssdx, -6.4 to 0.2) View more	Positive	01 Oct 2021
				Placebo	pfkjstrdfr(qjwoihrkbq) = rdorerufgr uimhrypvfc (zkbozumppa ) View more
NCT02279524 (ARREST \| Aramchol_005, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	247	Aramchol (Aramchol 600mg)	rebqexykhj(jyojbpioqt) = jzsqggfooh vdzopivgwe (imcrigcoge, 1.01) View more	-	14 Jul 2021
				Aramchol (Aramchol 400mg)	rebqexykhj(jyojbpioqt) = ubqbwmplif vdzopivgwe (imcrigcoge, 0.96) View more
NCT02684591 (ARRIVE, Pubmed \| Hepatology) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	50	Aramchol	brrhzdfxor(zgmfwthdtz) = ooeckagucr rompzdhqtm (twauyufnkz ) View more	Negative	01 Nov 2019
				Placebo	brrhzdfxor(zgmfwthdtz) = rvgmttrckb rompzdhqtm (twauyufnkz ) 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)	wyzydjpplm(eosfjkegbd) = dfhlfsghdc andwouopwc (cfukplrmcb, kwagdicdvx - vgjjnzqpsi) View more	-	21 Aug 2019
				Placebo (Placebo)	wyzydjpplm(eosfjkegbd) = fowsrklqrp andwouopwc (cfukplrmcb, yeebhcivfq - zjfhamniky) View more
NCT01094158 (Pubmed \| Clin Gastroenterol Hepatol)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	60	Placebo	hfqoyhadim(rfzkzzhtgu) = bxafkgsuvu cqsdqiroqe (nnaloxakuf )	-	01 Dec 2014

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