Radioactive tracer to measure effect of drug towards Crohn’s disease
Through a collaboration with the Karolinska Institutet, AstraZeneca has developed a radioactive tracer that, with the help of positron emission tomography (PET), can measure how a drug candidate, which the company has under development, affects the body. The marker binds to the protein CCR9, which is a chemokine receptor that plays a role in inflammation in the small intestine in Crohn's disease.
"There is currently no treatment that is highly effective for small intestine inflammation in Crohn's disease, so there is a great need", says Maria Belvisi, Senior Vice President and Head of Early research and development, Respiratory & Immunology, Biopharmaceuticals R&D at AstraZeneca, to Life Science Sweden.
The drug candidate that AstraZeneca is developing targets CCR9 and is intended to reduce the number of CCR9 positive cells in the small intestine, leading to a reduction in inflammation. The number of CCR9 positive cells can be measured in the blood of patients or through tissue samples, but AstraZeneca wanted to find a patient-friendly way to measure the effect directly in the small intestine over time in the patient group.
Traditionally, patients would have to take a biopsy, which is unpleasant and is neither time- or cost-effective and it cannot be done as often, Maria Belvisi explains.
Together with the Karolinska Institutet, they came up with the idea of developing a PET tracer based on a molecular inhibitor of CCR9 called vercirnon.
"We have now completed a phase I study with healthy volunteers using PET imaging, and it has shown really good identification of where CCR9 is in the intestine."
AstraZeneca has validated the marker and the idea is to use the CCR9 PET tracer to determine dosing in a phase II study with the drug candidate that is under development for the treatment of Crohn's disease. The plan is to start a phase II study with patients with Crohn's disease this year.
"We will be able to look at when we see depletion from the blood and when we see depletion from the small intestine, and how long the effect lasts. With this, we will then be able to determine dosing."
The results with the CCR9 PET tracer have not yet been published, but an abstract was presented at the ECCO (European Crohn's and Colitis Organization) scientific congress held in Stockholm at the end of February. And the results from the first clinical study with the drug candidate for the treatment of Crohn's disease will be presented at a scientific congress in May.
What does these kind of collaborations with academia mean to you as a pharmaceutical company?
"We publish and collaborate as much as we can because it is the only way we will be able to develop the best therapies for patients."
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