TEL AVIV - Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD), a clinical-stage biopharmaceutical company, has announced the publication of one-year results from the Open-Label part of its Phase 3 trial (ARCON) for Aramchol, a drug candidate targeting metabolic dysfunction associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). The findings were published in the medical journal Hepatology.
The trial, which involved 150 patients, aimed to evaluate the anti-fibrotic effects of Aramchol 300mg taken twice daily. The results confirmed earlier data showing a high rate of histological fibrosis improvement among subjects. The study utilized three objective measurements: NASH CRN, paired ranked reading, and Artificial Intelligence (AI) quantitative digital analysis to assess the drug's efficacy.
Aramchol is noted for its inhibition of Stearoyl-CoA desaturase-1 (SCD-1), a key enzyme in metabolic regulation. By targeting SCD-1, Aramchol is believed to enhance fatty acid oxidation in hepatocytes and influence AMPK, leading to reduced glycemic parameters. Additionally, it reportedly affects hepatic stellate cells, directly impacting fibrogenesis.
Galmed's strategy is to position Aramchol as a potential component in combination therapies for treating MASH. The company's research also extends to other fibroinflammatory and oncological indications beyond liver disease, including collaboration with the Hebrew University on developing Amilo5MER, a synthetic peptide.
The scientific community has shown interest in Aramchol's innovative mode of action, as highlighted by the publication in Hepatology. Prof. Vlad Ratziu, lead author of the paper and ARMOR study co-principal investigator, expressed that the rigorous multimodality histology assessment substantiates the drug's effectiveness.
Galmed's CEO, Allen Baharaff, expressed gratitude to the patients, clinical sites, and scientific advisors involved in the study. He also acknowledged the role of digital pathology and AI in advancing MASH clinical trials.
The company cautions that forward-looking statements about Aramchol's potential are subject to risks and uncertainties. Factors such as clinical trial outcomes, regulatory actions, and market acceptance could materially affect actual results.
This news article is based on a press release statement from Galmed Pharmaceuticals Ltd.
In other recent news, Galmed Pharmaceuticals Ltd. is broadening its drug development activities to include cancer and cardiometabolic diseases. This expansion follows positive results from its Phase 3 NASH study and recent scientific publications that underscore the role of Stearoyl-CoA desaturase1 (SCD1), the target of Galmed's drug Aramchol, in various diseases. The company's new programs aim to develop Aramchol-based drug combinations for advanced colorectal and hepatic cancers, and to investigate treatments for cardiac fibrosis.
Galmed is set to release new data from in-vitro and ex-vivo studies related to these programs in the fourth quarter of 2024. The company's recent funding activities, which raised $7.5 million through warrant exercises and drawdowns on an equity line, have extended its cash runway, enabling its strategic expansion.
These recent developments are part of Galmed's forward-looking plans and are subject to the usual risks and uncertainties associated with clinical trials and regulatory approvals. The company is leveraging its two decades of development of Aramchol, in collaborations with academia and industry, to address major health challenges affecting millions of people in the United States.
InvestingPro Insights
As Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) continues to make strides in the biopharmaceutical industry with its recent publication of Phase 3 trial results for Aramchol, investors are closely monitoring the company's financial health and stock performance. An InvestingPro analysis reveals a few key insights that could be of interest to stakeholders following the company's progress.
Firstly, GLMD has demonstrated a significant return over the last week, with a 16.67% price total return. This short-term uptick is part of a larger trend, as the stock has also seen a strong return over the last three months, boasting a 116.33% price total return. This momentum is reflective of the market's response to the company's recent developments and may indicate investor confidence in Galmed's ongoing clinical trials and research endeavors.
On the financial front, Galmed holds more cash than debt on its balance sheet, which is a positive sign for investors looking for companies with a solid financial footing. Additionally, the company's liquid assets exceed its short-term obligations, suggesting a degree of financial stability and the ability to meet its immediate financial responsibilities.
Despite these positive indicators, it's important to note that analysts do not anticipate the company will be profitable this year, and net income is expected to drop. Moreover, Galmed is not profitable over the last twelve months, which is a critical consideration for investors seeking long-term growth and profitability. It's also worth mentioning that the company does not pay a dividend to shareholders, which could influence the investment decisions of those looking for regular income streams.
The current market capitalization of GLMD stands at a modest $5.22 million USD, and the stock trades with high price volatility, which may appeal to certain investors looking for speculative opportunities but could deter those with a lower risk tolerance.
For those interested in a deeper dive into Galmed's financials and stock performance, InvestingPro offers additional tips and metrics. There are currently 12 more InvestingPro Tips available, providing a comprehensive analysis for informed decision-making. To explore these insights, visit: https://www.investing.com/pro/GLMD.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.