Allon Therapeutics Inc. announced this week it has received a major grant from the Michael J. Fox Foundation (MJFF) for Parkinson's Research to conduct pre-clinical research that will help determine the potential of the Company's lead neuroprotective drug, davunetide, as a treatment for Parkinson's disease (PD).
The newly funded research project will focus on the impact of davunetide on a key pathology in PD, namely alpha-synuclein. In collaboration with Prof. Marie-Françoise Chesselet of the University of California, Los Angeles (UCLA), the Charles Markham Professor of Neurology and Chairman of the Department of Neurobiology, a mouse model of PD will be administered various intranasal doses of davunetide and the impact on brain pathology and improvement in motor function will be measured. A previous preclinical project, also sponsored by MJFF, found that davunetide had a positive effect in both in vitro and in vivo models of PD. This grant will total $625,000.
"Because davunetide is already in clinical trials for progressive supranuclear palsy, a rare progressive movement disorder, the potential exists to rapidly bridge to a clinical trial in PD," said Todd Sherer, PhD, Chief Program Officer, The Michael J. Fox Foundation. "Our Foundation is dedicated to supporting groups like Allon who have promising PD therapies in development with a clear path forward toward practical relevance in patients' lives."
Additional collaborators on the project include Dr. Sheila Fleming, Assistant Professor, Departments of Psychology and Neurology at the University of Cincinnati, and Prof. Illana Gozes, a discoverer of davunetide, who is Professor of Clinical Biochemistry and The Lily and Avraham Gildor Chair for the Investigation of Growth Factors at Tel Aviv University.
This MJFF funding initiative is focused on developing treatments that target alpha-synuclein, a protein central to generation of Parkinson's pathology. To this end, mice that have high levels of alpha-synuclein were chosen because they progressively develop both the motor function problems and the neuropathology seen in Parkinson's disease, including a 40% decrease in dopamine neurotransmitter levels in the brain by 14 months of age. This serves as an excellent model system for testing of novel drug candidates like davunetide.
Allon's current clinical development focus is a pivotal Phase 2/3 clinical trial to evaluate davunetide as a treatment for progressive supranuclear palsy (PSP), a movement disorder with tau pathology that is often misdiagnosed as PD.
The Company has already completed Phase 2 clinical trials in which the efficacy of davunetide has been demonstrated in patients with amnestic mild cognitive impairment, a precursor to Alzheimer's disease, and cognitive impairment associated with schizophrenia. A pilot study of frontotemporal dementia patients also found davunetide to be safe and well-tolerated. The path forward in PSP represents a faster route to commercialization and to helping patients.
An estimated 1.5 million people in North America suffer from Parkinson's disease, a progressive neurodegenerative disease, and its incidence is expected to increase significantly over the next 25 years as the population ages. There is currently no cure for Parkinson's disease, and although drugs have been developed that can help patients manage many of the symptoms, these drugs do not stop the disease from progressing. Current therapies also have significant long-term side effects and often stop working. According to Datamonitor, sales of Parkinson's disease drugs in the seven major pharmaceutical markets was approximately $2.1 billion in 2008.
About the Michael J. Fox Foundation for Parkinson's Research
MJFF is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today. The Foundation has funded more than $213 million in research to date. For additional information please visit here.
About davunetide
Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon's laboratory and animal studies have shown that davunetide improves cognition in a number of disease models through a mechanism believed to involve effects on microtubules, structures in the brain critical to communication between cells.
About Allon's neuroprotective platforms
Allon's two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF).
Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer's disease, cognitive impairment associated with schizophrenia, and progressive supranuclear palsy (PSP). AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.
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Allon Therapeutics Inc.