The U.S. Food and Drug Administration has recently approved the phase 2 clinical trial of Bukwang Pharmaceutical's dyskinesia treatment, JM-010.
JM-010 is a candidate substance for a new drug developed by the bio-venture company, Contera Pharma, a subsidiary of Bugwang in Denmark. The medicine can cure dyskinesia, resulting from the long-term use of Levodopa to treat Parkinson's disease in more than nine out of 10 cases.
Contera Pharma will conduct the clinical trials in 190 patients at about 30 institutions in the U.S., who showed side effects of dyskinesia caused by the intake of Levodopa, to evaluate the safety and effectiveness of JM-010.
Bukwang completed pre-clinical phase 2 trials to prove concepts in 2016 and phase 1 clinical in 2017 after acquiring Contera Pharma in 2014. It obtained European approval for clinical trials and enrolled the first patient in 2018.
The clinical trial phase 2 in the U.S. is a separate protocol from phase 2 clinical trials currently underway in Europe, including Germany, France and Spain. A safe and proper dosage of JM-010 for the clinical trial phase 3 will be determined based on the results of the trials in the U.S. and Europe.
Bukwang said it has also been consulting with FDA for pre-investigational new drug applications about the clinical trial design and dosage and prepared a clinical trial protocol to reflect the FDA's recommendation and its strategy fully.
"We will step up the development of JM-010 as the FDA approved the clinical trials to bring hope to patients who have no suitable treatment for dyskinesia," the company said in a press release.
Contera Pharma is preparing for IPR at the Kosdaq market and has chosen Mirae Asset Daewoo as its lead manager. If the listing succeeds, Contera Pharma will be the first European company listed in the Korean stock market, making the most of the market rule that recognizes foreign companies that have excellent technology, Bukwang added.
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