Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients

Rhea-AI Summary

Can-Fite BioPharma submits IND application to FDA for Phase IIb study of Namodenoson in treating MASH, demonstrating positive effects in reducing hepatic steatosis, inflammation, and fibrosis.

Insights

Medical Research Analyst

The submission of an IND application for Namodenoson by Can-Fite BioPharma is a significant step towards expanding the clinical trial for the treatment of MASH, a condition with a growing patient population due to rising obesity and diabetes rates. The successful completion of the Phase IIa study and the progression to a Phase IIb study underscore the potential of Namodenoson in addressing a substantial unmet medical need. The fact that Namodenoson has already demonstrated anti-fibrotic, anti-steatotic and anti-inflammatory effects is promising, as these are key therapeutic targets for MASH treatment.

From a research perspective, the design of the Phase IIb study being multicenter, randomized, double-blind and placebo-controlled is critical for validating the efficacy of Namodenoson. The use of a histological endpoint for the primary efficacy objective is also noteworthy, as it provides a direct measure of the drug's impact on liver pathology. The potential market for MASH treatments is substantial, with estimates reaching $21.9 billion by 2028, indicating a significant opportunity for Can-Fite BioPharma if Namodenoson is successful in clinical trials and gains FDA approval.

Market Research Analyst

Can-Fite BioPharma's progression in the clinical trial stages for Namodenoson could have a notable impact on the company's valuation and investor interest, particularly in light of the recent FDA approval of Madrigal Pharmaceuticals' Rezdiffra for MASH. This approval not only validates the market but also sets a precedent for future treatments. The addressable market size for MASH treatments, which is expected to grow to nearly $22 billion, suggests that there is a substantial commercial opportunity for effective therapies.

Investors will be closely monitoring the IND approval process, as inclusion of US patients could enhance the diversity and robustness of the study's data. Furthermore, the successful development of Namodenoson could position Can-Fite BioPharma as a key player in a lucrative market, potentially leading to strategic partnerships or buyout opportunities. However, the competitive landscape is also a factor, with other pharmaceutical companies likely advancing their own MASH treatments, which could impact Can-Fite's market share and pricing strategies in the future.

Financial Analyst

The financial implications of Can-Fite BioPharma's IND submission extend beyond the immediate costs associated with the clinical trial. If Namodenoson proves to be effective and gains regulatory approval, the future revenue streams could be significant. Given the biopsy-confirmed MASH requirement for trial participants, the selection criteria suggest a focus on patients with a definitive diagnosis, which could streamline the trial and potentially improve the drug's efficacy profile.

It is important to note that clinical trials are inherently risky and the capital required to fund them is substantial. The outcome of the Phase IIb study will be a pivotal moment for Can-Fite, with success likely leading to a surge in stock value, while failure could have the opposite effect. Long-term investors will be considering the potential return on investment against the risks of drug development, including the possibility of delayed or denied FDA approval, or less than expected clinical efficacy.

• Namodenoson demonstrated anti-fibrosis, anti-steatosis and anti-inflammatory effects in former Phase IIa study
• Patient enrolment for Phase IIb study is ongoing in Europe and Israel

RAMAT GAN, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study.

Can-Fite’s drug candidate, Namodenoson, has been shown to reduce hepatic steatosis, inflammation, and fibrosis, as well as body weight reduction, in a Phase IIa clinical study where data have been already published in a peer scientific journal (Link to Manuscript). Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.

The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.

"We are eager to look at the therapeutic effect of Namodenoson in patients with MASH," said Motti Farbstein, chief executive officer of Can-Fite. "Prior human data showed that treatment with Namodenoson leads to significant anti-MASH effects. Namodenoson’s novel liver-protective mechanism of action provides a unique opportunity to potentially improve inflammation and reduce hepatic steatosis and fibrosis which may provide important therapeutic benefits for patients."

Rates of MASH are increasing in the United States in concert with increasing rates of obesity and diabetes and is estimated to affect 2-5% of adult Americans. By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis, potentially paving the way for more drugs that target this huge market.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. 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 known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240403043294/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What is Can-Fite BioPharma submitting to the FDA for Phase IIb study?

Can-Fite BioPharma is submitting an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) for the Company’s ongoing Phase IIb clinical study.

What positive effects did Namodenoson demonstrate in the Phase IIa study?

Namodenoson demonstrated anti-fibrosis, anti-steatosis, and anti-inflammatory effects in the Phase IIa study, along with body weight reduction.

What is the primary efficacy objective of the Phase IIb trial for Namodenoson?

The primary efficacy objective of the Phase IIb trial is to evaluate the efficacy of Namodenoson compared to placebo in 140 subjects with MASH, as determined by a histological endpoint.

What is the estimated addressable pharmaceutical market size for MASH by 2028?

By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size.

What did Madrigal Pharmaceuticals announce in March 2024 related to MASH treatment?

In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis.