Bukwang Pharm Subsidiary Fails Clinical Trial for Parkinson's Disease Aftereffect Treatment Drug

Conterapharma, a Danish subsidiary of Bukwang Pharmaceutical, has failed to demonstrate efficacy in the Phase 2b clinical trial of JM-010, a drug developed to treat side effects of Parkinson's disease. Although the parent company OCI Holdings Chairman Lee Woo-hyun had emphasized it as a key pipeline, the failure in the clinical trial has put the future development of the drug at risk of being discontinued.

Researchers at the Contera Pharma Institute located in Copenhagen, Denmark, are conducting new drug development research.
Photo by Lee Chunhee

On the 21st (local time), Conterapharma announced that JM-010 failed to meet the primary endpoint in the Phase 2b 'ASTORIA' trial. JM-010 was developed as a treatment for dyskinesia, a side effect that can occur when taking levodopa, a Parkinson's disease medication. Dyskinesia affects approximately 900,000 patients across the seven major countries including the United States and the United Kingdom, and the number of patients is expected to continue increasing due to aging populations. However, the only approved treatment in the U.S. also has side effects such as visual hallucinations, and no approved drugs exist in Europe, indicating a high unmet medical need.

The ASTORIA trial was conducted on 81 Parkinson's disease patients experiencing dyskinesia. However, the Phase 2b topline results showed that after 12 weeks of treatment with two doses of JM-010, the change in the total score of the Unified Dyskinesia Rating Scale (UDysRS), set as the primary efficacy endpoint, decreased by only 0.3 points and 4.2 points compared to placebo in the two experimental groups, failing to achieve statistical significance. In terms of safety, both experimental groups showed similar safety and tolerability data, and no serious adverse reactions were reported.

Conterapharma is expected to focus on the development of other pipelines such as CP-012, which is being developed as a treatment for early morning akinesia, another Parkinson's disease-related disorder, rather than continuing the development of JM-010. Thomas Seager, CEO of Conterapharma, said, "Although the ASTORIA trial results are disappointing, Conterapharma will continue research on Parkinson's disease," and added, "We will accelerate the development of CP-012."

However, Bukwang Pharmaceutical plans to monitor the results of the ongoing Phase 2a clinical trial of JM-010 in the U.S., as patient recruitment was completed in January. This trial is designed in two parts: Part 1 to confirm dose optimization and Part 2 to evaluate safety and efficacy. The topline results of Part 1 are expected to be available within the first half of the year.