NEWS

Bukwang receives US FDA approval for JM-010 phase 2 clinical study IND

- Contera Pharma is preparing for public offering in KOSDAQ -

Bukwang has recently received the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with phase 2 clinical study of JM-010.

JM-010, originating from a Danish bioventure company Contera Pharma, is currently under development for treating dyskinesia which emerges in up to 90% of Parkinson's disease patients following long term treatment of levodopa. Following acquisition of Contera Pharma by Bukwang in 2014, the clinical development activity has been continuously progressing with the completion of clinical proof of concept study in 2016, completion of phase 1 clinical study in 2017, approval of Clinical Trial Application (CTD) for phase 2 European study in 2018 followed by enrollment of patient in the study and then finally recent IND clearance for phase 2 US study from the FDA.

The phase 2 US clinical study will enroll 190 dyskinetic Parkinson's disease patients receiving levodopa-based therapy from approximately 30 sites across the country. The clinical study will assess antidyskinetic efficacy as well as safety and tolerability of JM-010.

Another phase 2 clinical study with different protocol is currently ongoing in Europe, including Germany, France, and Spain. The results from these two phase 2 clinical studies (US and EU) will be a basis for determining safe and effective dosing regimen for future phase 3 clinical study.

Bukwang's representative mentioned "based on consultation with the FDA through pre-IND meeting, the study design and the dosing regimens have been carefully determined and the protocol has been carefully written to make sure the agency' recommendations and Bukwang's strategy are inline. With the FDA IND clearance, JM-010 clinical development will be accelerated to provide effective treatment for patients suffering from debilitating Parkinson's disease dyskinesia.

Additionally, Contera Pharma is currently preparing to go public, with Mirae Asset Daewoo as the underwriter for the planned 2021 initial public offering (IPO) in KOSDAQ. Provided the IPO is successful, Contera Pharma is expected to be the first European company listed in the domestic market. With its good performance and the lead candidate now in the late clinical stage, Contera Pharma plans to go public through ‘technology growth company’ track with KOSDAQ.

Having the global clinical development activities and IPO process now in place, boost confidence that Bukwang’s open innovation approach is on the right track.

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