Can-Fite Enrolls First Patient in Phase II NAFLD/NASH Study with Namodenoson
|·||Data show Namodenoson’s efficacy in reducing liver fat and fibrosis in NASH models|
|·||No FDA approved drug yet for NASH indication, an unmet medical need estimated to reach $35-40 billion by 2025|
PETACH TIKVA, Israel, November 27, 2017 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today that the first patient, of the planned 60 patients, has been enrolled in a Phase II trial of its drug candidate Namodenoson (CF102) in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.
Can-Fite’s 12-week study is being led by Key Opinion Leaders in the area of NASH and liver disease. Clinical trial sites are some of the most prestigious medical institutions in the world including Hadassah Medical Center and Rabin Medical Center.
“By enrolling the first patient in this study, we move forward to evaluate the potential of Namodenoson to help the growing number of people diagnosed with NASH and its precursor, NAFLD,” stated Can-Fite CEO Dr. Pnina Fishman. “We believe that the liver protective effect of Namodenoson in NASH models, together with the drug’s robust safety profile, make it a promising drug candidate for this indication. There is a pressing and unmet need in the medical community for a variety of safe and effective drugs to treat fatty liver disease. We believe our 12-week Phase II study, designed by the world’s leading experts in NAFLD and NASH, can efficiently inform the potential of Namodenoson in this indication.”
The Phase II multicenter, randomized, double-blinded, placebo-controlled, dose-finding study of the efficacy and safety of Namodenoson in the treatment of NAFLD/NASH is enrolling approximately 60 patients with NAFLD, with or without NASH. Patients are being enrolled in three arms, including two different dosages of Namodenoson and a placebo, given via oral tablets twice daily. The study's primary endpoints are percent change from baseline in liver triglyceride (fat) concentration and safety.
The Phase II trial design is based on preclinical studies showing Namodenoson's efficacy in reducing liver fat, ballooning, and fibrosis in NASH models. Can-Fite’s estimated cost for the Phase II trial is under $1 million.
NAFLD is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a study published in Hepatology, an estimated 17%-33% of the population in the U.S. has NAFLD, with a higher prevalence in people with type II diabetes. Incidence is increasing based on rising obesity rates. NAFLD includes a range of liver diseases, with NASH being the more advanced form, manifesting as hepatic injury and inflammation. According to the NIH, the incidence of NASH in the U.S. is believed to affect 2-5% of the population. The spectrum of NAFLDs resembles alcoholic liver disease; however, they occur in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.
About Namodenoson (CF102)
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being 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. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) 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, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in early 2018. Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). 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 in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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