GSK, Sanofi, Denali take part in FNIH Parkinson’s biomarker project

A $21 million public-private project led by the Foundation for the National Institutes of Health (FNIH) will see government agencies, nonprofits and industry giants hunt for biomarkers that distinguish Parkinson’s diseases from similar conditions. 

The Accelerating Medicines Partnership in Parkinson’s Disease and Related Disorders, or AMP PDRD, was announced by the FNIH on July 17. It builds on an earlier effort, AMP PD, to identify biomarkers associated with the condition.

Two biopharma companies involved in the first project—GSK and Sanofi—are involved in AMP PDRD, along with Denali Therapeutics.

There is no cure for Parkinson’s disease, a neurodegenerative condition believed to be caused by the breakdown of brain cells that produce the neurotransmitter dopamine. That process is linked to the aggregation of a protein called alpha-synuclein within those neurons. In April 2023, researchers showed that a seed amplification assay (SAA) called SYNTap, commercialized by Amprion, can detect alpha-synuclein proteins in skin and spinal tap samples before the hallmark movement symptoms are apparent. This could pave the way for early interventions. 

There’s just one problem. Parkinson’s isn’t the only disease in which alpha-synuclein plays a role—dementia with Lewy bodies, multiple system atrophy, and progressive supranuclear palsy (PSP) all have similar etiologies, presenting a risk of misdiagnosis that could undermine clinical trials. 

AMP PDRD aims to solve this issue by validating SAAs for Parkinson’s; identifying unique biomarkers that distinguish it from other conditions; and learning how these markers change over time, enabling drugmakers to come up with precision medicines.

Collaborators will also look for markers that can differentiate subtypes of Parkinson’s from one another, as well as develop noninvasive platforms and tools that can detect signatures of all the conditions in blood or saliva. 

In addition to pharmas, C2N Diagnostics, a company that is commercializing tests for Alzheimer’s disease and other neurodegenerative conditions is also involved in AMP PDRD. The nonprofits the Michael J. Fox Foundation and CurePSP are partners as well, as is the research initiative ASAP. 

Working alongside the nonprofit and industry partners are the National Institute of Neurological Disorders and Stroke, the National Institute on Aging and the FDA. The FNIH has launched 11 partnerships under its AMP program so far, including one in May that’s focused on ALS.

Editor's note: After this article published on July 17, FNIH reached out to clarify that BMS and Pfizer are not involved in the new partnership, as an earlier version stated. The previous version also included information about separate design and execution phases; FNIH said that they are now in the execution phase. Information about the design phase was removed.