By acquiring a 100% stake in Contera Pharma, a Denmark-based biotech specializing in the central nervous system (CNS) in 2014, Bukwang Pharmaceutical secured the development and commercialization rights outside of Europe for JM-010, an innovative new drug candidate for Parkinson's disease-related dyskinesia.
Parkinson's disease patients generally undergo long-term treatment with
levodopa (L-dopa), the standard therapy for symptom relief. However, as the
disease progresses over time, patients lose the ability to regulate the dopamine
generated by levodopa. Consequently, approximately 40 to 50% of patients
experience dyskinesia after five years of standard treatment, and nearly all
patients develop these involuntary movements after ten years.¹ Currently, there
are no widely approved treatments specifically for Parkinson's disease-related
dyskinesia, with the exception of extended-release amantadine, which is only
available in the United States.
JM-010 successfully completed an early Phase 2 clinical trial in South Africa
and a Phase 1 trial in Germany, followed by the completion of a late-stage
Phase 2 clinical trial in Europe (including Germany, France, Spain, Italy, and
Slovakia) and South Korea. Additionally, it was designated as an "Orphan Drug
in the Development Stage" by the South Korean Ministry of Food and Drug
Safety (MFDS) in 2017.
As a drug repositioning strategy utilizing a combination of substances with
already proven safety profiles, JM-010 acts on both presynaptic dorsal raphe
nucleus (DRN) neurons and postsynaptic medium spiny neurons (MSNs),
demonstrating therapeutic potential for Parkinson's disease-related dyskinesia.²
Although the top-line results from the European Phase 2 clinical trial
announced in May 2024 did not meet the primary endpoints, the company is
currently evaluating potential utilization strategies for the clinical data moving
forward.