RAMAT GAN, Israel - Can-Fite BioPharma (NYSE:CANF) Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company focused on developing proprietary small molecule drugs for cancer and inflammatory diseases, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA).
The submission is for the inclusion of U.S. patients in a Phase IIb clinical study of its drug candidate, Namodenoson, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH).
Namodenoson has shown promise in a former Phase IIa clinical study, demonstrating potential therapeutic effects such as reducing hepatic steatosis, inflammation, and fibrosis, along with body weight reduction. The findings from this study have been published in a peer-reviewed scientific journal.
The ongoing Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study, aiming to enroll 140 subjects with biopsy-confirmed MASH. Participants are randomly assigned to receive either oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for a period of 36 weeks.
Motti Farbstein, CEO of Can-Fite, expressed optimism about the drug's potential, citing previously observed significant anti-MASH effects. With the rates of MASH increasing in the U.S. due to the rise in obesity and diabetes, the addressable pharmaceutical market for MASH is anticipated to grow substantially, reaching an estimated $21.9 billion by 2028.
The recent FDA approval of Rezdiffra (resmetirom) by Madrigal Pharmaceuticals (NASDAQ:MDGL) for MASH treatment is seen as a positive development for the market.
Namodenoson is an orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells. This selectivity is believed to contribute to the drug's safety profile. Can-Fite's pipeline also includes Piclidenoson for psoriasis, which is expected to enter a pivotal Phase III trial, and CF602 for erectile dysfunction.
This press release includes forward-looking statements regarding Can-Fite's product development and business prospects. However, these statements are subject to various risks and uncertainties that could affect the company's future results.
The information in this article is based on a press release statement from Can-Fite BioPharma Ltd.
InvestingPro Insights
As Can-Fite BioPharma Ltd. (NYSE American: CANF) progresses with its clinical trials for Namodenoson, potential investors and industry stakeholders are closely monitoring the company's financial health and stock performance. The latest data from InvestingPro provides a mixed picture of the company's current financial status.
According to InvestingPro Data, Can-Fite's Price / Book ratio stands at 1.7 as of the last twelve months ending Q4 2023, which can be an indicator of how the market values the company relative to its book value.
Despite challenges in profitability, as evidenced by a negative P/E Ratio of -1.39 and a negative PEG Ratio of -0.03, the company holds a strong liquidity position. This is reflected in the fact that Can-Fite holds more cash than debt on its balance sheet, an InvestingPro Tip that suggests financial resilience.
Moreover, another InvestingPro Tip highlights that Can-Fite's liquid assets exceed its short-term obligations, indicating a solid capability to meet its immediate financial liabilities. This could be reassuring for investors considering the company's ability to sustain operations during its extensive research and development phase.
Still, it is important to note that analysts do not anticipate the company to be profitable this year, and the stock's Relative Strength Index (RSI) suggests it is currently in overbought territory. These factors may influence investment decisions, especially in light of the company's non-profitability over the last twelve months and its price performance, which has been poor over the last decade.
For those interested in a deeper dive into Can-Fite's financials and stock performance, InvestingPro offers additional insights. There are 6 more InvestingPro Tips available for Can-Fite, which can be accessed by visiting https://www.investing.com/pro/CANF. To enhance your investing strategy, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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