Prothena Corporation plc
May 4, 2015

The Michael J. Fox Foundation and Prothena Partner to Accelerate Discovery of Novel Biomarkers for Parkinson's Disease

 

NEW YORK and DUBLIN, Ireland, May 4, 2015 (GLOBE NEWSWIRE) -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) and Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced an agreement under which they will seek to accelerate the discovery of novel biomarkers and development of assays to measure Parkinson's disease progression. The joint initiative will focus on biomarkers that may facilitate therapeutic approaches targeting alpha-synuclein, a protein potentially involved in the onset and progression of Parkinson's disease.

"As more potential therapies come closer to and cross the line to clinical testing — and, in parallel, the number of people with Parkinson's grows as the population ages — the need for Parkinson's biomarkers grows more urgent," said Todd Sherer, PhD, CEO of MJFF. "Prothena is a leader in the development of potential treatments against our highest priority target, alpha-synuclein, and we are pleased to collaborate with them toward these tools to speed research."

As part of the initiative, Prothena and MJFF will support scientific research studies directed toward biomarkers of disease progression and drug efficacy. In addition, Prothena and MJFF will work to identify opportunities where novel endpoints or assays may be incorporated into ongoing or future studies.

"We are committed to identifying new insights about the underlying cause and progression of Parkinson's disease and believe that biomarkers clearly defining disease progression may both enhance this understanding and enable more effective, efficient clinical development of disease-modifying therapeutics for patients and families impacted by Parkinson's disease," said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "In addition, we believe this collaboration with MJFF will help inform the clinical development strategy for PRX002, a monoclonal antibody for the potential treatment of Parkinson's disease. We look forward to reporting results from our ongoing Phase 1 multiple ascending dose study of PRX002 in patients with Parkinson's disease during the first half of 2016."

The Michael J. Fox Foundation has supported research in Parkinson's biomarkers from its earliest days and leads the landmark observational Parkinson's Progression Markers Initiative, a $60 million study taking place at 33 clinical sites around the world that aims to validate biomarkers of Parkinson's disease. Biological markers that point to risk, onset or progression of Parkinson's disease would allow researchers to more accurately diagnose and monitor Parkinson's, stratify subjects for clinical studies, and efficiently evaluate impact of disease-modifying therapies, informing critical go/no-go decisions.

About Alpha-Synuclein

Alpha-synuclein is a protein found in neurons and is a major component of pathology that characterizes several neurodegenerative disorders including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, which collectively are termed synucleinopathies. While the normal function of synuclein is not well understood, the protein generally occurs in a soluble form. In synucleinopathies, the synuclein protein can misfold and aggregate to form soluble aggregates and insoluble fibrils that contribute to the pathology of the disease. There is also increasing evidence that this disease-causing synuclein can be propagated and transmitted from neuron to neuron, resulting in an infection-like spread of neuronal death. Recent studies in pre-clinical models suggest that the spread of synuclein-associated neurodegeneration can be disrupted by targeting aberrant forms of synuclein.

About Parkinson's Disease

Parkinson's disease is a degenerative disorder of the central nervous system that affects one in 100 people over age 60, and after Alzheimer's disease is the second most common neurodegenerative disorder. There are an estimated seven to ten million patients living with Parkinson's disease worldwide. Current treatments for Parkinson's disease are only effective in managing symptoms of the disease, mainly through the use of levodopa and dopamine agonists. As the disease progresses and dopaminergic neurons continue to be lost, these drugs eventually become less effective at treating the symptoms. In contrast, therapies that target alpha-synuclein may slow or reduce the neurodegeneration associated with aberrant forms of alpha-synuclein.

About The Michael J. Fox Foundation for Parkinson's Research

As the world's largest nonprofit funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $450 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.

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About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs for the potential treatment of diseases that involve amyloid or cell adhesion. The Company is developing antibody-based product candidates that target a number of potential indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002), and psoriasis and other inflammatory diseases (PRX003).

For more information, please visit the Company's web site at www.prothena.com.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the potential of the announced collaboration to accelerate the discovery and development of novel biomarkers to measure Parkinson's disease progression, speed research, enable clinical development and inform the development strategy of disease-modifying therapeutics; the timing of reporting data from Prothena's Phase 1 multiple ascending dose study for PRX002; the potential benefits of biological markers in Parkinson's disease; and the potential of PRX002 to slow or reduce neurodegeneration. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks, uncertainties and other factors described in the "Risk Factors" sections of Prothena's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 13, 2015, and Prothena's subsequent Quarterly Reports on Form 10-Q filed with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena's expectations.

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