A metabolite is produced every time a chemical process occurs in our body. These molecules, in turn, can metabolise again or they can produce another metabolite, thus creating a type of chain. It was long thought that the study of these substances could describe an individual’s state of health; however, it wasn’t until the 1960s and ‘70s when the first quantitative studies started to be carried out.
During these decades, metabolomics led to significant progress in the fields of organic chemistry, biotechnology and analytical instrumentation, and it is expected to offer much more in the future with the aid of technological and computational innovations.
In Spain, one of the leading researchers in this field is Dr José María Mato, and his work has been recognised with the Gregorio Marañón National Research Award in Medicine, the most prestigious scientific award granted in the country. The results of his findings and scientific developments led to One Way Liver, a biotechnology company based in the Basque Country, and the company that its Scientific Director, Pablo Ortiz, talks to us about in this interview.
One Way Liver and non-alcoholic fatty liver disease
How did One Way Liver start?
One Way Liver was founded by Dr. José María Mato in 2002 with the aim of developing diagnostic products for complex diseases initially found in the liver. Since 2004, focus has been placed on metabolomics and the company started to develop a non-invasive diagnosis for fatty liver, while also offering metabolomics services to the academic world and to the pharmaceutical and biotechnology industry.
What is the current status of the project?
At present, the company has started to market its first product for diagnosing fatty liver and its progression to NASH (non-alcoholic steatohepatitis), a disease associated with obesity and diabetes that affects 20-30% of the world’s population. Moreover, One Way Liver is an established provider of metabolomics for the academic, pharmaceutical and biotechnological sectors.
One Way Liver specialises in non-alcoholic fatty liver disease. What does this disease entail?
Fatty liver is the accumulation of triglycerides and cholesterol esters in the liver. In fact, it comprises a spectrum of diseases ranging from the most benign phase, such as steatosis (fatty liver), to the most severe phases, such as non-alcoholic steatohepatitis (NASH) or NASH with advanced fibrosis, which is a pre-cirrhotic phase. Fatty liver is considered to be the most common hepatic disease in Western countries, with a prevalence of 20-30% and which increases due to its link to obesity and type 2 diabetes mellitus (DM2).
Therefore, the quick and early detection of fatty liver is important to stop the disease from progressing.
Diagnostic test for the early detection and monitoring of patients
One of the main business lines are diagnostic tests. How important are these tests for controlling the disease?
One Way Liver has developed OWLiver®, which makes it possible to stage the disease in all of its phases (normal liver, simple steatosis, NASH and NASH with fibrosis) with a simple blood analysis. This makes it ideal for use in screening the at-risk population, such as those who suffer from type 2 diabetes and are overweight. It is a very useful method for monitoring patients when they have to follow a diet and exercise regimen or when they undergo bariatric surgery, both of which are the currently accepted treatments for this disease.
Why is early detection important?
Identifying the disease in its early phases with the test makes it possible to select patients suffering from NASH who are at a greater risk for developing cirrhosis. This allows proper treatment to be provided before the disease progresses and becomes irreversible.
These tests are already available to doctors and patients under certain circumstances. Where? What controls and certifications were needed to obtain them?
OWLiver® has the CE marking and it is available in Spain, marketed by Laboratorios Rubió.
It was positively assessed by Osakidetza in 2018 and it is funded and available in the Basque Country. Another 20 public healthcare hospitals regularly request the test to monitor patients with fatty liver.
Patents as a guarantee and international recognition
What role has the protection of Industrial Property had on the company’s success?
In 2012, we were granted the first metabolomics patents for diagnosing NASH in the United States and this gave us a major boost to ensure a significant period of use and make investors trust that they have enough time to recover their investment.
Later, upon completing the patents to protect OWLiver® key markers, we were internationally recognised for our innovation in a highly competitive field.
What factors determined its strategy to protect international industrial property?
In addition to using patents to protect the markers found and the algorithms developed, we noticed that in this field trade secrets must also be used for the final optimised product, which is the product that is validated most intensively.
Our IP attorney highlights: