New PET Tracer with Potential to Diagnose Parkinson’s to Be Tested in First-in-Human Study

An innovative Positron Emission Tomography (PET) tracer that has the potential to diagnose Parkinson’s disease will soon be tested in humans for the first time.

Led by Switzerland-based AC Immune, which developed the technology, the study is expected to begin in the second half of 2018. The company recently presented the data on its new product at the AAT-AD/PDTM Focus Meeting 2018 in Turin, Italy.

“We are excited about this significant step in our development of potentially the first ever PET tracer for earlier and more accurate diagnosis of Parkinson’s,” Andrea Pfeifer, CEO of AC Immune, said in a press release. “This important milestone underlines our vision to become a global leader in precision medicine of neurodegenerative diseases, leveraging our proprietary technology platform.”

The company used its Morphomer platform, designed to interact with misfolded and aggregated proteins, to develop the PET tracer, which is highly selective for alpha-synuclein, enabling an earlier and more accurate Parkinson’s diagnosis.

AC Immune’s technology is aimed at not only detecting alpha-synuclein in patients, but also monitoring the effects of treatments targeting protein clumps. The research program has been spotting small molecules selective for alpha-synuclein and suitable for development as PET tracers.

Upon entering the brain, the new imaging agent, called a PET tracer, binds to abnormal or misfolded alpha-synuclein. Its radioactive label enables the imaging device to detect bound alpha-synuclein, informing clinicians on the amount and distribution of pathological brain alpha-synuclein.

If successful, the new PET tracer would be the first alpha-synuclein tracer to receive regulatory approval for commercial distribution. Its specificity would be important not only for Parkinson’s patients, but also for other disorders characterized by aggregated alpha-synuclein, collectively called synucleinopathies.

AC Immune has been collaborating with Biogen on this program since April 2016. The companies will proceed with the development and seek clinical validation for the use of the PET tracer as an imaging biomarker for Parkinson’s.

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is supporting this project. “We are very pleased about this next important step in the development of an alpha-synuclein imaging agent,” Jamie Eberling, PhD, director of research programs at MJFF, said.

“Having a PET tracer to detect and track Parkinson’s disease would be transformative for Parkinson’s research and patient care,” she said.