- Foundation celebrates first regulatory approval from funded portfolio with FDA decision on Inbrija for "off" episodes
- Unique investment strategy "de-risks" early-stage projects for larger partners
NEW YORK (December 26, 2018) -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) announces the first regulatory approval of a Parkinson's treatment funded by the Foundation. Inbrija from Acorda Therapeutics, Inc. received approval from the U.S. Food and Drug Administration on December 21, 2018, for the treatment of "off" episodes, when Parkinson's symptoms are not well controlled with oral medication.
"Our strategy of funding high-risk, high-reward projects with a focus on patient impact has paid off," said MJFF CEO Todd Sherer, PhD. "Today people with Parkinson's have a new option to manage life with the disease. Because of our Foundation's investments, many more treatments to manage symptoms and to stop progression are moving closer to pharmacy shelves and patient hands."
The Foundation partially funded Phase I and II trials of Inbrija -- an inhaled powder of the gold-standard Parkinson's medication levodopa -- by biotechnology company Civitas Therapeutics in 2011 and 2013 with two grants totaling $1.3 million. After multiple rounds of venture capital investment, Acorda Therapeutics acquired Civitas in 2014 and continued the development of Inbrija.
De-risking Investments for Larger Partners
MJFF provides early-stage therapeutic projects with the capital needed to advance. Grantees use its funding to build evidence of safety and efficacy, which can attract larger partners with resources for later-stage testing, regulatory processes, and commercialization. The Foundation directs its donor-raised funds to the areas of most pressing patient need: from better symptom management to treatments to slow, stop or even prevent Parkinson's progression.
"The way The Michael J. Fox Foundation does it is really best in class. The lack of bureaucracy and obstacles encourages emerging companies to seek funding and engagement and ultimately advance their projects," said Glenn Batchelder, co-founder and former CEO of Civitas Therapeutics and member of the MJFF Board of Directors.
This "de-risking" model has advanced dozens of Parkinson's therapies. Treatments with potential to slow or stop the disease are marching through clinical trials with new partners after early MJFF funding. Therapies targeting individual symptoms are experiencing similar momentum, and the Food and Drug Administration is currently reviewing another MJFF-funded Parkinson's treatment for "off" episodes: APL-130277 from Sunovion Pharmaceuticals.
New Option for Unmet Patient Need
The newly approved Inbrija helps quickly alleviate symptoms of tremor, slowness and stiffness. With long-term oral levodopa use and advancing disease, these aspects of the disease can re-emerge between medication doses. These "off" episodes can greatly impact quality of life, bringing uncertainty to one's days and limiting ability to complete daily tasks.
A 2014 MJFF survey of more than 3,000 people with Parkinson's disease found that more than 60 percent of respondents were in an "off" state for two or more hours per day and nearly 50 percent said their "off" episodes caused them to avoid or stop activities.
Acorda Therapeutics CEO Ron Cohen notes, "It was clear thanks to the work of MJFF that 'off' episodes were a serious symptom for many Parkinson's patients. Acorda committed to addressing this, and the FDA approval means patients will soon have a new treatment option."
Acorda and The Michael J. Fox Foundation are collaborating on a number of projects, including a study of how patients, care partners and doctors discuss "off" episodes to identify gaps in communication and thereby optimum care.
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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 $800 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.
Media Contact:
Allison Boiles
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