(FINANCIALPRESS) — Non-alcoholic steatohepatitis, or NASH as it is more frequently called, is an advanced form of non-alcoholic fatty liver disease (NAFLD) characterized by buildup of fat in the liver and related inflammation and damage not caused by alcohol use. In some biotech circles, NASH is understandably called the next great untapped market due to the fact that there is a dearth of treatments for the disease that affects up to 30 million Americans. With contributing factors known to be obesity and diabetes, it should be expected that NASH diagnoses will continue to rise in the future. Silent and potentially deadly, most people don’t even know they have NAFLD or NASH until latter stages. Even more serious is the pathogenesis of related diseases, considering that NASH can lead to cirrhosis, which leads to liver failure, and liver cancer, not to mention increased risk for cardiovascular disease, a leading killer of Americans year-in and year-out.
It’s expected that NASH will be the leading cause of liver transplants by 2020. Sad fact is that only about 6,000 hepatic transplants happen annually, meaning there is a desperate need for new therapies to treat the gamut of liver diseases. Currently, there are no FDA-approved drugs for NASH and only a handful in late-stage clinical studies.
There are reasons that companies like Gilead, Dicerna and Galectin have seen big swings upward in value on data from their drugs in NASH trials. Intercept Pharma, once thought to have the top experimental NASH drug had its stock skyrocket from under $20 to nearly $500 in 2013-2014.
Can-Fite BioPharma Ltd. (CANF) (CFBI) has a pipeline of advanced drugs for an array of diseases, including CF101 (Piclidenoson), which is in a phase 3 for rheumatoid arthritis with a phase 3 for psoriasis expected early this year, and mid-stage studies for liver cancer, NAFLD/NASH and glaucoma. Amongst other things, the company is differentiated from peers due to all its drug candidates being orally bioavailable (the preferred dosing method of patients) and acting upon the A3 adenosine receptor (A3AR).
With usage in over 1,000 patients, Can-Fite’s pipeline has repeatedly demonstrated a robust safety profile.
The Israel-based company’s lead experimental drug for liver disease is Namodenoson, also called CF102. CF102 is being developed as a second-line treatment for hepatocellular carcinoma under Orphan Drug designations in the U.S. and Europe and a Fast Track designation from the FDA.
On Wednesday, Can-Fite said it struck a new collaboration research agreement with the acclaimed Hadassah Medical School in Jerusalem, Israel. The teams will work together to support the research of Dr. Rifaat Safadi with the goal of better understanding the Namodenoson mechanism of action (MOA)through lab tests in models of NASH. Dr. Safadi, a venerable expert in NASH, is the Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center and Professor of Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at Hadassah University.
The new work is underscored by recent pre-clinical studies showing CF102 checked three key boxes in NASH by improving steatosis, inflammation and ballooning, the leading parameters defining NAFLD Activity Scores.
“Can-Fite’s Namodenoson drug is unique among today’s NASH drugs under development due to its excellent safety profile and the positive effect on steatosis, inflammation and fibrosis. We are very happy to initiate this collaboration,” said Dr. Safadi in a statement on the new partnership.
The pre-clinical data to date is proving invaluable with setting protocol for the Phase 2 study in NAFLD/NASH patients, for which enrollment was recently initiated. Can-Fite changed the primary endpoint to a reduction in inflammation as measured by blood alanine aminotransferase (ALT) levels and the top secondary endpoint to a percentage of liver fat as determined via proton density fat fraction (PDFF). These changes were made based upon the evolving understanding of CF102’s MOA and should better position the company to meet the key endpoints in the study.
With no drugs available to reduce liver fat, stop and/or reverse liver scarring, pharmas are seeing the multi-billion-dollar opportunity with NAFLD and NASH, an area that is basically a blue sky away from the fierce competition in most other indications. This explains why Gilead didn’t give up after its lead anti-fibrosis drug failed, instead acquiring two new candidates from smaller biotechs and why Allergan became a leading player by buying Tobira Therapeutics and striking a pact with privately-held Akarna Therapeutics. Given the environment and fervor, investors would be wise to keep an eye out for ongoing deal activity as companies race to get the first mover advantage.
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