FDA Formally Supports the aSyn-SAA as a Tool for Clinical Trials
Fall / Winter 2024 | Research 9
Multiomics Effort Aims to Uncover PD ’ s Earliest Biological Changes
Investigators at Alkahest are using a cutting-edge approach to analyze plasma from individuals who donated while healthy but then went on to develop PD later in life . Their “ multiomics ” approach integrates data from genomics , transcriptomics , epigenetics , proteomics , metabolomics and other areas to shed light on the molecular changes underlying the earliest stages of PD , before outward symptoms develop . Findings from the study , called the Chronos-PD Pilot , could lead to diagnostic tests for Parkinson ’ s and reveal novel targets for therapeutics capable of preventing the disease and slowing its progression . MJFF provided Alkahest with funding needed to conduct this innovative research .
FDA Formally Supports the aSyn-SAA as a Tool for Clinical Trials
In a development announced as this issue went to press , the U . S . Food and Drug Administration ( FDA ) published a letter detailing the importance of the alpha-synuclein seeding amplification assay ( SAA ), the new biomarker validated last year in MJFF ’ s Parkinson ’ s Progression Markers Initiative ( PPMI ), to PD drug development . The agency acknowledged MJFF and PPMI ’ s role in advancing the SAA as a tool for disease staging and drug development and cited the important role of similar biomarkers in recent approvals of the first disease-modifying therapies for Alzheimer ’ s disease and ALS . This public signal of support from the FDA is expected to significantly increase the tool ’ s use in clinical trials .