Titan Pharmaceuticals has announced that the first patient has been treated in a Phase I/II trial of its ropinirole subdermal implant for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
Parkinson's
The subdermal implant was developed using the company’s ProNeura drug delivery technology and is designed for the long-term continuous delivery of ropinirole — a dopamine agonist for the treatment of Parkinson’s symptoms and restless leg syndrome, which is currently available in daily or more frequently dosed oral formulations.
“Patients on oral formulations of dopamine and dopamine agonists will often develop serious motor complications and dyskinesias. These complications are due to the daily pattern of peak-trough levels of medication in the blood, duration and severity of disease, and the requirement of higher doses of levodopa. Providing a long-acting dopamine agonist with a flat pharmacokinetic profile can aid in reducing these complications,” added Dr Aaron Ellenbogen of the Michigan Institute of Neurological Disorders, and the principal investigator at the first trial site, near Detroit, Michigan. “With more than 10 million people worldwide suffering from Parkinson's disease, new and better treatments are needed and we look forward to further evaluating the potential of a ropinirole implant in this study.”
The open-label, sequential, dose escalation Phase I/II study is being conducted in three clinical research sites in the US that specialise in Parkinson’s. Approximately 20 patients with idiopathic Parkinson’s will be enrolled and the primary objectives of the study will be to characterise the pharmacokinetic profile of the implant, evaluate the safety and tolerability as well as to explore potential signals of efficacy. Patients who are currently on a stable dose of L-dopa plus oral ropinirole will have the oral ropinirole switched with the implant for three months. Data is anticipated from the first cohort of patients early next year with completion expected at the end of 2018.
“We are pleased to begin treating the first patient in this important study to evaluate the pharmacokinetic profile, safety and tolerability of our ropinirole implant, which is designed to deliver continuous, non-fluctuating levels of this dopamine agonist for up to three months,” said Kate Beebe, PhD, Titan's executive vice president and chief development officer. “We believe our ropinirole implant has the potential to offer patients substantial benefits over existing daily and more frequently dosed oral formulations of ropinirole, and we look forward to continuing to enrol subjects in this study.”