Bilatzailea
[Metabolomics in the development of new drugs]
The occurrence of unexpected side effects is usually a reason for the withdrawal of drugs from the market. Unexpected side effects can sometimes be very serious, leading to the death of the affected person. Liver damage is one of the most serious possible side effects and is the main reason for the withdrawal of drugs from the market.
The CIC bioGUNE research centre has developed a new method for the effective and rapid detection of liver damage caused by drugs, which can be used by pharmaceutical companies in the process of developing new drugs.
Zamudioko CIC bioGUNE Ikerkuntza kooperatiboko zentroko metabolomika-departamentua da honako hau. Metabolite recognition is the goal of those who work in this laboratory, that is, they strive to identify the molecules that the human body produces in biological processes.
Juan Manuel Falcón; CIC bioGUNE:
“Metabolomics is a new technology. Thanks to it, we can study small molecules, small molecules that can be in the blood, in the urine, or inside the cell, and acquire information about biological processes.”
Depending on the biological process, the metabolites will be of one form or another, i.e. different metabolites will be produced. When cells are fed, certain metabolites appear, while when they die, others appear. In humans, about 3,000 metabolites have been identified to date, while 30,000 different metabolites are known in plants. That is, 30,000 small molecules have been identified that are produced in the metabolism of plants.
Juan Manuel Falcón; CIC bioGUNE:
“In biological processes, such as the development of cancer, metabolomics have been used to recognize which metabolites, which small molecules appear.”
Considering the possibilities of metabolomics, the Livertox project was launched two years ago. In addition to CiC bioGUNE, the pharmaceutical industry of the Basque Country and two biotechnology companies from the Zamudio technology park have participated in the project. The goal has been to develop a method for rapid and easy detection of liver damage.
Juan Manuel Falcón; CIC bioGUNE:
“The main idea has been to provide drug companies with a tool to decide whether the drugs being developed will cause liver damage to rats.”
Developing a new drug is a long and expensive task. The average time between the discovery of a molecule and its commercialization is ten years, and in the subjects tested, only one in 10,000 comes to the market.
Before being given a marketing authorisation, a new drug has to go through two important stages of research. The first period of the study is called the pre-clinical phase. During this research phase, attempts are made to determine if the substance works as expected. These tests are performed on laboratory animals, preferably rats.
Dizziness, stomach problems, headache, etc. The list of side effects that can be read in the package leaflets of the medicines is usually long. But sometimes, after taking a drug, unexpected problems, unexpected side effects, including severe liver damage, occur. Hepatotoxicity can cause very serious clinical symptoms and is the main reason for the withdrawal of drugs from the market.
Several methods are currently used to detect potential liver damage caused by drugs, but they do not have the desired sensitivity.
Juan Manuel Falcón; CIC bioGUNE:
"Many drugs have to be discarded after marketing because they cause liver damage. Therefore, in order to offer new, fast and more sensitive tools for detecting liver damage, we have used metabolomics technology."
Some known drugs are known to cause hepatotoxicity. They took advantage of these drugs to develop Livertox. First, liver damage was induced in laboratory animals. In the next step, serum or serum extracted from the research animals was analyzed on a mass spectrometer. This allowed us to know which metabolites, which small molecules were present in the serum. A comparison of metabolites found in the serum of animals without liver damage and animals harmed revealed 20 small molecules, 20 metabolites that appear altered when the liver is damaged.
The product has been designed for use by pharmaceutical companies in drug development. For this reason, it is essential to have a mass spectrometer to use Livertox.
Juan Manuel Falcón; CIC bioGUNE:
“Livertox is a software that connects to the mass spectrometer and when it analyzes the serum of a rat, it will tell the machine which peak, which mass, which metabolite to look at to decide whether there is liver damage or not.”
The first phase of Livertox’s development has been completed and a patent has been applied for in Europe. At the beginning of the year, the improvement phase at CIC bioGUNE began. From now on, the twenty metabolites detected so far will be tried in greater depth. The objective is to know the behavior of these metabolites in the presence of liver diseases.
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