SAN FRANCISCO & GENEVA—Amarantus BioScience Holdings Inc. and Chiltern International, a leading global contract research organization (CRO), have begun a clinical trial agreement, under which Chiltern will manage the clinical research and monitoring program services for the Phase 2b study of Amarantus' eltoprazine in Parkinson's disease levodopa-induced dyskinesia (PD-LID).
The most commonly prescribed treatments for Parkinson's disease tend to be levodopa-based therapies. Once administered, the body converts levodopa into dopamine, to combat the dopamine loss that characterizes Parkinson's disease. However, as dopamine neurons in the brain are lost, levodopa's therapeutic efficacy decreases, and increased use often comes with a side effect of dyskinesias, or involuntary, uncontrollable, exaggerated jerky movements.
Eltoprazine is a small-molecule 5HT1A/1B partial agonist being developed for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID) and adult attention deficit hyperactivity disorder (ADHD). The compound was originally developed by Solvay Pharmaceuticals, and when the company merged with Abbott Pharmaceuticals, the program was out-licensed to PsychoGenics, who licensed it to Amarantus after successful proof-of-concept trials in PD-LID and adult ADHD.
"We selected Chiltern as our CRO partner for PD-LID Phase 2b development because of their proven excellence in quality and reliability in drug development along with their exceptional expertise in the managing the comprehensive and extensive international clinical study regulatory requirements," noted Gerald E. Commissiong, president and CEO of Amarantus. "Now that our investigator meetings have been completed in both the U.S. and the EU, we are ready to commence the eltoprazine dose response, efficacy and safety trial this quarter. The expansion of our team, via our collaboration with Chiltern, will allow us to advance the PD-LID program as efficiently and quickly as possible. The next step is to initiate our first clinical site and begin screening patients for enrollment in the study."
The Phase 2b trial is a double-blind, placebo-controlled, four-way crossover, dose range-finding, clinical study. The goal will be to evaluate dose response effect of repeated eltoprazine dosing on safety, tolerability and dyskinesia severity using rating scales, diaries and motion sensors. The study will also evaluate eltoprazine's pharmacokinetics and pharmacodynamics.
Chiltern will be responsible for managing all clinical activities related to the study, including clinical trial site approval and authorization, investigator and staff training, patient recruitment, timeline and budget monitoring, centralized program tracking systems, regulatory controls and responsibilities, data monitoring committee organization and administration, and trial data quality control and final data lock.
"Our mission is to provide premier CRO services to innovative and forward-thinking biopharmaceutical companies. As such, we are pleased to partner with Amarantus and manage the initiation of their Phase 2b study with eltoprazine,” Dr. Jim Esinhart, CEO of Chiltern, said in a press release. “We recognize that PD-LID can be severely disabling and impact quality of life for Parkinson's patients, and utilizing our award-winning trial management program and over 30 years of industry expertise, we look forward to advancing eltoprazine to its next level of clinical development and one step closer to fulfilling its therapeutic potential for patients with PD."