Multi-arm international trial evaluates investigational therapies to slow or halt Parkinson’s disease progression in prodromal patients

Zeist, the Netherlands, and Atlanta, GA — July 7, 2026 — P95 Julius Clinical, a global, science-led contract research organization (CRO), today announced its submission of the first regimen-specific protocol to the U.S. Food and Drug Administration (FDA) for the Path to Prevention (P2P) platform trial, sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF). The submission comes just five months after the company was engaged as the trial’s clinical operations partner in December 2025. Building on the expertise of Peachtree BioResearch Solutions (Peachtree), which joined the company through a 2025 merger, P95 Julius Clinical has since contributed to protocol development across all planned investigational regimens and will oversee trial operations at approximately 35 sites across the United States, United Kingdom, Germany, and the Netherlands.

“To reach a regulatory milestone like this so soon after joining the program is a real testament to the dedication and expertise of our global team,” said Kristy Nichols, Global Head of Neuroscience at P95 Julius Clinical and former Founder and President of Peachtree. “I am deeply proud of the team behind it whose scientific depth and operational excellence is matched by a genuine commitment to patients, exactly what this work demands.”

Drawing on more than 15 years of longitudinal data from the Parkinson’s Precision Medicine Initiative (PPMI), the trial uses a perpetual multi-arm platform design, allowing multiple investigational therapies to be evaluated simultaneously under a single Master Protocol. P2P capitalizes on PPMI’s study infrastructure, expertise, and ongoing clinical and biomarker data collection to de-risk industry investment in pioneering therapies for individuals at risk of a Parkinson’s diagnosis.

Despite being the world’s fastest-growing neurological disorder, existing treatments for Parkinson’s disease only manage symptoms, leaving patients without an approved therapy that slows, stops, or prevents its progression. The consequences of that gap are mounting faster than anticipated with Parkinson’s costs in the U.S. reaching $82.2 billion in 2024, more than a decade ahead of prior projections. By identifying individuals who carry confirmed biological markers of Parkinson’s before any clinical diagnosis, the P2P trial could help determine whether early intervention can alter the course of the disease.

“It is a privilege to support MJFF’s bold vision for a trial that could change what is possible for people living with Parkinson’s,” said Bassem Saleh, M.D., CEO of P95 Julius Clinical. “Supporting a study of this magnitude reflects exactly what we are built to do: bring scientific rigor and operational discipline to the most complex trials in medicine.”

P95 Julius Clinical’s depth in neuroscience and complex trial operations positions the company to support trials of this scale and ambition. Together with MJFF and the trial’s collaborators, P95 Julius Clinical aims to bring the field closer to the first therapies capable of changing the course of Parkinson’s.

About AKEURA

AKEURA is a specialist contract research organization (CRO) with dual expertise in clinical and real-world settings, from early- through late-phase clinical development to real-world evidence (RWE). With more than 25 years of experience and more than 500 researchers, clinicians, and scientists across five continents, AKEURA helps sponsors advance medicines across their full lifecycle, with an exclusive focus on three therapeutic areas: neuroscience, infectious diseases and vaccines, and cardiometabolic diseases. In each, it brings the experience, reach, and hands-on expertise to give every promising medicine the study it deserves. Formerly P95 Julius Clinical, AKEURA is headquartered in Zeist, the Netherlands, and backed by Ampersand Capital Partners. Learn more at akeura.com.