Bukwang Pharm. and its fully owned subsidiary Contera Pharma are pleased to announce that the investigational medical product, JM-010 has been dosed to the first patients with Parkinson’s disease suffering from moderate to severe levodopa-induced dyskinesia. The Phase IIa/Proof-of-Concept study is a randomized, double-blind, placebo-controlled, 2-way crossover study, which will assess the efficacy, safety/tolerability and pharmacokinetics of JM-010. It is planned to complete the dosing of at least 25 patients by first quarter 2016 followed by reporting later in H1 2016.
Hee-Won Yoo, President and co-CEO of Bukwang stated that “The start of this important study is a significant milestone for Bukwang Pharm. and underlines a successful acquisition of Contera Pharma.”
The co-founder and inventor of Contera Pharma and the JM-010 product, Mikael Thomsen, CSO said “The start of this study is a significant milestone for all the patients suffering from levodopa-induced dyskinesia as there is no approved treatment and JM-010 could be the first new approved effective and safe treatment paradigm.”
If the Phase IIa clinical trial is successfully completed, Bukwang is planning to carry out the Phase IIb trial in Europe.