EMA issues positive opinion on biomarker for Parkinson’s trials

30th July 2018 (Last Updated July 30th, 2018 00:00)

Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), along with Parkinson’s UK, has announced that the European Medicines Agency (EMA) issued a positive qualification opinion on biomarker as a tool to boost clinical trials on Parkinson’s.

EMA issues positive opinion on biomarker for Parkinson’s trials
Parkin crystal structure. Credit: Jftrempe

Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), along with Parkinson’s UK, has announced that the European Medicines Agency (EMA) issued a positive qualification opinion on biomarker as a tool to boost clinical trials on Parkinson’s.

The aim of this biomarker is to act as a measurement that can be used to choose people with Parkinson’s who are most suitable for clinical trials.

This biomarker helps to determine the presence of dopamine transport deficiency in the brain.

Qualified as an enrichment biomarker for clinical trials targeting early stages of Parkinson’s soon after diagnosis, it involves the intravenous injection of a small amount of a radioactive tracer before the brain images are acquired and can be done at any one of many specialist imaging centres.

The imaging agent binds particularly to dopamine transporter sites on the neurons that are lost in Parkinson’s disease.

With the use of this biomarker, patients can be better identified that are more likely to exhibit significant progression in their motor signs and symptoms, thereby helping in the selection of patients for clinical trials.

The CPP consortium is a global public-private partnership comprising industry, academics, advocacy organisations, and government agencies collaborating to develop solutions to optimise drug development for Parkinson’s.

"These brain scans in themselves are not new, but until now there has not been a clear consensus that they can and should be used to select participants for clinical trials."

This qualification is considered to be a major milestone as it is claimed to be the first biomarker for Parkinson’s to receive such a regulatory designation.

In 2015, the US Food and Drug Administration issued a letter of support for the use of this imaging biomarker for use in Parkinson’s clinical trials.

CPP executive director Dr. Diane Stephenson said: “This endorsement from the European Medicines Agency represents many years of hard work and incredible collaboration among companies, universities, and charities facilitated by the Critical Path Institute.

“These brain scans in themselves are not new, but until now there has not been a clear consensus that they can and should be used to select participants for clinical trials.

“Through our global project, we’ve been able to bring all the data and expertise together to make a powerful case, so we’re delighted that this endorsement from the EMA will improve the quality and chances of success for future trials of Parkinson’s treatments. This success is just the first in a suite of new tools that we hope to deliver for Parkinson’s.”

According to studies, up to 15% of individuals taking part in clinical trials for new Parkinson’s treatments may not show a measurable progression in motor signs and symptoms over the course of such trials.

Furthermore, the level of uncertainty in predicting disease progression is higher at initial earlier stages of the condition.