Development of a new treatment for “fatty liver disease”
Quebec City, 14-07-2021—DIEX Research, a world-class Quebec-based company that conducts high-quality clinical research, is currently involved in the development of an experimental treatment for “fatty liver disease,” or non-alcoholic fatty liver disease, which affects as many as one in five Canadians, including a growing number of children.
Thanks to DIEX’s expertise in the Quebec City area and the financial support of the pharmaceutical company Pfizer, sponsor of the study, DIEX has been able to put together a team of specialized professionals who will spend the next few months conducting in-depth research on this disease for which there is still no satisfactory treatment.
“This kind of study will completely change the way we treat the disease in the future,” says Dr. Pascale Chouinard, the study’s principal investigator and a gastroenterologist, FRCPC, with a subspecialty in hepatology.
The study is evaluating the efficacy of two experimental oral medications. A first molecule is either administered alone or the same molecule is co-administered with a second molecule. The efficacy of the drugs is then evaluated, in particular by liver biopsies (samples of the liver). This is the first study of its kind to be conducted. “We are in Phase II, says Dr. Chouinard. Phase I has shown promising preliminary results, which gives us great hope for the future.”
A Difficult Disease to Diagnose
A specific subset of non-alcoholic fatty liver disease, called non-alcoholic steatohepatitis or NASH, results from the accumulation of fat in the liver cells, usually due to overconsumption of sugars and fats. This accumulation of fat causes liver inflammation and liver damage, and eventually leads to cirrhosis, the final stage of the disease. And when the damage becomes too severe, the only solution is to perform a liver transplant.
NASH is also associated with an increased risk of cardiovascular disease and leads to a deterioration in the quality of life of individuals, from fatigue to severe clinical symptoms. This is why it is important to treat it as early as possible.
The problem is that NASH is a silent disease and is most often diagnosed too late. “First of all, it doesn’t cause any specific signs or symptoms,” explains Dr. Chouinard. When the first signs appear, it is often too late, the disease is well established. The first signs are fatigue, jaundice, edema or digestive bleeding. “Blood tests and medical imaging can identify liver abnormalities,” says the gastroenterologist.
But these tests are not enough to make a diagnosis. The only effective way to detect the disease is a liver biopsy.
Canada’s First Clinical Research Study with Pfizer
To conduct the study, Pfizer provided DIEX with a FibroScan®, a device that quantifies liver fibrosis non-invasively, allowing for a painless examination. This device is generally only available in hospitals.
Thus, DIEX is the only clinical research centre in Canada, in collaboration with Pfizer, capable of conducting such research outside the hospital setting. The company relies on the expertise of its team of seasoned professionals, its scientific rigour and its creativity. Well-equipped to meet the challenges of developing new solutions for various diseases, DIEX is also currently conducting several other innovative studies, including the development of a plant-based vaccine against COVID-19 for the pharmaceutical company Medicago.
Opportunity to participate in the clinical study
Anyone with liver disease may be eligible to participate in this study conducted by DIEX.
Interested individuals will be assessed by telephone by a recruitment specialist. If successful, they may then go through a screening process to determine eligibility for the clinical study.
The company is located at 205 Montmagny Street, Suite 102-103, Quebec City. Anyone interested can contact DIEX at 581-477-3439 or toll-free at 1-844-739-3439, or by email at info@diex.ca. For more information about the company: www.diex.ca.