RAMAT GAN, Israel, May 9, 2024–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a portfolio of proprietary small molecule drugs that treat oncology and inflammatory diseases, today announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) authorization for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s Phase IIb. clinical study
Namodenoson is an orally bioavailable small molecule drug that targets the A3 adenosine receptor, overexpressed on the surface of pathological liver cells in MASH, but not on normal cells. This may make Namodenoson an ideal specific candidate for the treatment of MASH. In fact, in a Phase IIa clinical study, Namodenoson has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Can-Fite is currently enrolling patients for a Phase IIb clinical study in Europe and Israel and approval of the IND by the FDA will allow patient recruitment in the US.
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 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 matching placebo for 36 weeks.
“The activation of the IND for the treatment of MASH patients with Namodenoson, opens the door for the enrollment of patients in the United States and will contribute to the heterogeneity of the population of this study,” said Motti Farbstein, director general of Can-Fite. “As we are already enrolling patients for this study, we expect to complete recruitment in the coming months. We are committed to improving the lives of patients with MASH and depending on the drug’s effectiveness in the Phase IIa study, we are proud to develop a potential new treatment to address this disease.”
Rates of MASH are increasing in the United States in line with rising rates of obesity and diabetes and are estimated to affect 2-5% of American adults. By 2028, Vantage Market Research estimates that the addressable pharmaceutical market for MASH will reach $21.9 billion. 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 targeting this huge market.
About Namodenoson
Namodenoson is a small, orally bioavailable drug that binds with high affinity and selectivity to the adenosine A3 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, while low expression is found in normal cells. This differential effect explains the drug’s excellent safety profile.
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 designed to address multibillion-dollar markets in the treatment of cancer, liver and inflammatory disease. . The Company’s lead drug candidate, Piclidenoson, recently reported first-line results in a Phase III trial for psoriasis and is expected to initiate a pivotal Phase III. Can-Fites’ cancer and liver drug, Namodenoson, is being evaluated in a phase IIb trial for the treatment of steatotic liver disease (SLD), a pivotal phase III trial for hepatocellular carcinoma (HCC ) and the company is planning a phase IIa study. in pancreatic cancer. Namodenoson has received orphan drug designation in the US and Europe and fast-track designation as a second-line treatment for HCC by the US Food and Drug Administration. Namodenoson has also demonstrated proof of concept to potentially treat other cancers, including colon, prostate and melanoma. CF602, the Company’s third drug candidate, has demonstrated efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in more than 1,600 patients in clinical studies to date. For more information, visit: www.canfite.com.
Forward-looking statements
This press release may contain forward-looking statements about Can-Fites’ 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 release, other than those relating to historical facts, are “forward-looking statements.” Forward-looking statements may be identified by the use of forward-looking words such as “believe,” “expect,” “attempt,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations . of these words or other comparable words or because these statements do not relate strictly to historical or current matters. Forward-looking statements refer 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, such statements are inherently subject to known and unknown risks, uncertainties and other factors that could cause actual results, performance or achievements of Can-Fites to differ materially different from future results. performance or achievements expressed or implied by 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 our need for additional capital to finance our operations and our inability to obtain additional capital on acceptable terms, or at all; cash flow uncertainties 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 successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory applications 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 extent of protection we can establish and maintain for the 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 failure to satisfy NYSE American’s continued listing requirements; and statements about the impact of the political and security situation in Israel on our business. More information about these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fites’ Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports submitted to the SEC and in its periodic statements to the TASE. Current and potential 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 revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by any applicable securities laws.
View the source version at businesswire.com: https://www.businesswire.com/news/home/20240509103593/ca/
contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
#CanFite #FDA #Grants #IND #Clearance #Namodenoson #Treat #Patients #MASH #Phase #IIb #Study
Image Source : finance.yahoo.com