Liver disease, including cirrhosis, viral hepatitis, and liver cancers, cause an estimated 2 million deaths per year worldwide. Accounting for 3.5% of deaths worldwide every year, the cost of comorbidity, disability, and health care utilization exacerbate the global burden of liver disease. With over 100 diseases affecting the liver and an ever-increasing patient population, the liver disease treatment market is estimated to reach approximately $19.5 billion by 2022.
Autoimmune hepatitis (AIH) is a rare Autoimmune disease causing inflammation of the liver. If left untreated, AIH can cause serious liver damage leading to liver fibrosis, cirrhosis, or organ failure requiring a liver transplant. The global prevalence of AIH is estimated at 1-7 patients per 100,000 population and is the underlying cause in an estimated 6% of liver transplants. The frequency of AIH among chronic liver disease sufferers is between 11-16%.
The current treatment options available for liver disease sufferers in general and AIH sufferers, in particular, are largely steroid-based. AIH treatment frequently combines steroids with immunosuppressive medication azathioprine. This standard of care for AIH is associated with severe side effects that lead to non-adherence and relapse in up to 86% of patients. The negative outcomes associated with steroid treatment present an unmet need for improved, alternative AIH treatment strategies to lower the dosage and duration of steroid administration.
Researchers focusing on improved treatment options for liver disease have found evidence that cannabidiol (CBD), a non-psychotropic component of cannabis sativa, possesses immunomodulatory and anti-inflammatory properties that are effective in improving outcomes in patients. Numerous recent studies have contributed to a mounting body of evidence demonstrating CBD’s therapeutic potential for liver disease application. For example, CBD was shown to improve brain and liver function in animal trials investigating neuropsychiatric abnormalities resulting from acute or chronic liver failure. The restoration of neurological, cognitive, and motor functions indicates that CBD may be a promising tool for treating complications associated with end-stage liver disease. Similar benefits were found in studies exploring the efficacy of CBD in treating alcohol-induced liver injury, including a recent study demonstrating the striking evidence that cannabis use reduces the prevalence of progressive alcohol-related liver disease in alcoholics. The powerful anti-inflammatory and antioxidant effects of CBD were found to have great potential in mitigating ethanol liver damage. Additional studies examining the efficacy of CBD in cirrhosis of the liver have likewise concluded that this is a beneficial addition to liver disease treatment.
STERO Biotechs Ltd. is an Israeli clinical-stage company dedicated to the research and development of cannabidiol-based treatment solutions to reduce the side-effects and need for steroid therapy. The basis for Stero’s research is preliminary evidence from a phase II trial, conducted under Talent Biotechs. The trial demonstrated that CBD administration reduced the need for steroid intervention and lowered risk of graft-versus-host-disease (GVHD) following allogeneic hematopoietic cell transplantation (alloHCT). CBD administration was further shown to maintain or improve the therapeutic effects of steroids, leading to lower rates of negative side-effects and improved adherence. Stero holds an approved patent for using CBD as a steroid-sparing therapy and in February 2019 initiated a phase II clinical trial focusing on AIH. Additional trials are planned for April 2019 and onward.
The U.S. Food and Drug Administration recently granted orphan drug status to CBD for the treatment of autoimmune hepatitis (AIH), presenting an opportunity for STERO’s study for the development of steroid-sparing CBD treatment targeting AIH. Benefits associated with orphan drug status include 7-year market exclusivity, tax credits on US clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees. In August 2018, STERO Biotechs Ltd. received an official U.S. patent covering the use of CBD to reduce, improve, and replace current steroid treatment protocol in over a hundred autoimmune and chronic inflammatory diseases, including AIH. With huge therapeutic potential and market opportunity, STERO Biotechs Ltd. is developing steroid-sparing CBD-based solutions that could potentially benefit millions and generate countless treatment products.