Amarantus Announces First Clinical Trial Site and Patient Enrollment in Phase 2b Study for Eltoprazine in Parkinson’s Disease Levodopa-Induced Dyskinesia
Amarantus BioScience Holdings, Inc, a company that develops diagnostics and treatments for syndromes in the fields of neurology, psychiatry, ophthalmology and regenerative medicine, recently announced the opening of the first clinical site in its Phase 2b trial that will assess the efficacy of eltoprazine in treating patients with Parkinson’s disease levodopa-induced dyskinesia (PD-LID).
Eltoprazine is a small molecule 5HT1A/1B partial agonist in clinical development as treatment for Parkinson’s disease levodopa-induced dyskinesia (PD-LID). Parkinson’s disease (PD) is a chronic, progressive neurodegenerative disorder that causes motor symptoms such as rigidity, tremors, slowed movements and non-motor symptoms such as mood disorders, cognitive impairment and autonomic dysfunction. Parkinson’s disease levodopa-induced dyskinesia (PD-LID) is an involuntary movement condition caused by levodopa-based therapy, the most commonly prescribed medicine for Parkinson’s disease. About 60-80% of patients with PD patients have PD-LID, a dyskinesia that can be severely disabling and impact quality of life as it disturbs patients’ ability to perform routine daily tasks.
The first study site will be the Parkinson’s Disease and Movement Disorders Center of Boca Raton, a clinical research institution well-known for its cutting-edge treatments to improve PD symptoms and decelerating the disease’s progression.
“We are pleased that the first Parkinson’s disease center of excellence is now available for enrollment in our PD-LID clinical study with eltoprazine,” said Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc., in a recent press release. “Advancing eltoprazine in this Phase 2 program represents an important milestone for the Company and a critical step in building momentum with our therapeutic pipeline where we expect to make significant progress over the course of 2015.”
“I look forward to commencing dosing in this important Phase 2b trial, especially given the data from the earlier eltoprazine Phase 2a study demonstrating such encouraging tolerability and significantly reduced peak dose dyskinesia,” commented Dr. Isaacson. “I believe eltoprazine has tremendous potential as a meaningful therapy to address a significant unmet need and improve the quality of life for individuals with Parkinson’s disease.”
The Phase 2b study will be a placebo-controlled, multicenter, double-blind, crossover, range finding, clinical study that will assess the dose response effect, efficacy, safety, tolerability pharmacodynamics, pharmacokinetics and dyskinesia severity of eltoprazine 60 PD patients.
The Company expects to have trial results in 2016. Additional study sites throughout the Europe and the US will be forthcoming for the Phase 2b clinical study with eltoprazine for the treatment of PD-LID.
Glossary of Terms:
[wikibox lang=”en”]Levodopa-induced dyskinesia[/wikibox]