7/8/2014 6:12:19 AM
Biotie Therapies has signed a USD 2 million research contract with The Michael J. Fox Foundation (MJFF) to investigate SYN120 in Parkinson's disease patients with dementia. SYN120 is a dual antagonist of 5-HT6 and 5-HT2a receptors and these two distinct modes of action could result in a unique therapeutic profile for SYN120 combining pro-cognitive and antipsychotic activities.
"There is an urgent need to find safe and effective treatments for Parkinson's patients suffering from impaired cognition," said Timo Veromaa, Chief Executive Officer at Biotie. "We look forward to collaborating with MJFF and the Parkinson Study Group to advance SYN120 into a Phase 2 trial later this year. This grant provides a great opportunity to further characterize the potential of this drug candidate".
MJFF will fund an 80 patient, Phase 2a, randomized, double-blind, placebo-controlled trial of 16 weeks duration in patients with Parkinson's disease dementia. In addition to assessing safety and tolerability, the main focus of the trial will be to establish efficacy of SYN120 on cognition using the Cognitive Drug Research (CDR) Computerized Cognition Battery as the primary efficacy endpoint. This trial, which is expected to begin in H2 2014, will be conducted by the Parkinson Study Group (PSG) at approximately 10 US sites specializing in cognitive dysfunction in Parkinson's disease. Biotie and the PSG will share responsibility to design and execute this study. Further details, including study design and goals, can be found at https://www.michaeljfox.org/foundation/grant-detail.php?grant_id=1342.
"A substantial number of Parkinson patients will develop dementia. While patients and doctors may not openly discuss dementia during clinic visits, its presence may be the single most important factor limiting the use of standard pharmacotherapy for the motor impairments in Parkinson's disease," says Hubert H. Fernandez, MD, the Co-Chair of the Parkinson Study Group Executive Committee and the study's Principal Investigator.
Biotie retains the rights to SYN120 and will be able to use data from the MJFF-funded study for any future regulatory submission.
Turku, 8 July 2014
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SYN120 is an oral, potent, dual antagonist of the 5-HT6 and 5-HT2a receptors. These two distinct properties could result in a unique therapeutic profile for SYN120 combining pro-cognitive and antipsychotic activities. SYN120 has completed single and multiple ascending dose Phase 1 clinical studies and a Phase 1 positron emission tomography imaging study to determine therapeutic dose for subsequent Phase 2 studies.
Having considered partnerships for the further development of SYN120, the Company has concluded that it will be better served by progressing SYN120 internally to the next stage of development. Preparations are underway for a Phase 2 MJFF-funded Parkinson's disease dementia study, which is expected to begin recruitment by the end of 2014, and a Phase 2 study in Alzheimer's disease.
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private 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 $300 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.
For more information, visit:
Web site: michaeljfox.org
About the Parkinson Study Group
The not-for-profit PSG is the largest and oldest network of Parkinson's disease clinical trial sites and their credentialed investigators (movement disorders physicians) and clinical coordinators, with 132 clinical sites across the United States, Canada and the Caribbean. Since 1986, the PSG has partnered with industry, government and philanthropic institutions to conduct over 40 PD clinical studies, enrolling over 7,000 subjects and contributing to regulatory approval of 4 antiparkinsonian therapeutics. The PSG is based at the Massachusetts General Hospital in Boston, Massachusetts.
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. For the past years, Biotie has successfully operated a strategy built around search, profile and partner. This has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in February 2013 and is currently being rolled out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a antagonist which is transitioning into Phase 3 development for Parkinson's disease and for which Biotie holds exclusive, global rights. Biotie is actively developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a dual antagonist for which Biotie initially expects to conduct a Phase 2 study in Parkinson's disease dementia that is largely funded by the Michael J Fox Foundation; nepicastat, a selective inhibitor of dopamine beta hydroxylase which is currently in a Phase 2 study, fully funded by NIDA, for treatment seeking cocaine addicts; and BTT-1023, a monoclonal antibody targeting Vascular Adhesion Protein 1 for which Biotie intends to conduct a Phase 2 study in primary sclerosing cholangitis, a rare fibrotic disease of the liver. Biotie's shares are listed on NASDAQ OMX Helsinki.
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