Titan Pharmaceuticals (NSDQ:TTNP) has treated the first patient in a Phase I/II trial of its ropinirole implant designed to treat the signs and symptoms of idiopathic Parkinson’s disease.
Ropinirole is a dopamine agonist traditionally given orally to patients with Parkinson’s disease or restless leg syndrome. Titan’s ropinirole implant uses the company’s ProNeura drug delivery tech to continuously deliver ropinirole HCl.
The company hypothesizes that continuous delivery of ropinirole could potentially lessen the serious motor complications that some patients experience taking daily doses of oral ropinirole.
“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,” principal investigator Dr. Aaron Ellenbogen said in prepared remarks.
“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 trial is slated to enroll 20 patients with idiopathic Parkinson’s disease. Researchers plan to characterize the pharmacokinetic profile of the ropinirole implants and to evaluate their safety and tolerability over three months.
Titan said it expects the study to finish by the end of next year.
“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,” Kate Beebe, Titan’s EVP & chief development officer, added.
“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 enroll subjects in this study.”
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