Bukwang Pharma 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 Pharma stated: The start of this important study is a significant milestone for Bukwang Pharma and underlines a successful acquisition of Contera Pharma.
The co-founder and inventor of Contera Pharma and the JM-010 product, Mikael Thomsen, CSO stated: 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.
About Bukwang
Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange [KRX:003000]. The company has been in business for over 50 years, and achieved US$140 million in sales in 2014. Sales are primarily derived from products licensed from Europe, the United States, and Japan. The company is currently investing significant resources in R&D to create a robust pipeline of preclinical and clinical agents for the treatment of antiviral diseases, gastrointestinal disorders, CNS disorders and metabolic disease.
About Contera Pharma
Contera Pharma (www.conterapharma.com) is a Danish clinical stage biotech company focusing on discovery and development of new innovative drugs for treatment of movement disorders for which there is a high unmet medical need.
Contera Pharma was founded in 2010 is now fully owned subsidiary of Bukwang Pharm. Co., Ltd acquired in November 2014.
For more information contact John Bondo Hansen, CEO (jbha@conterapharma.com) or Mikael Thomsen, CSO (mst@conterapharma.com).
About JM-010
JM-010 holds a novel mechanism-of-action as a fixed dose combination of two safe marketed products in a proprietary formulation for treatment of L-DOPA induced dyskinesia (LID) in Parkinson’s disease (PD). The novel mechanism-of-action combines effects of different serotonergic receptor agonists. The combination exploits the mechanism of actions and the synergistic effects of the two drugs, neither of which is approved for treatment of PD or LID. Strong preclinical data in a validated model of LID is supported by experimental clinical studies.