Bukwang Pharma halts JM-010 clinical trials after setback

Bukwang Pharmaceuticals announced Thursday the termination of its U.S. clinical trials for JM-010, a drug intended to treat dyskinesia in Parkinson's disease patients. This follows Contera Pharma's failure to meet primary efficacy endpoints in a phase 2b trial in Europe.

n Wednesday, Contera Pharma, a Copenhagen-based subsidiary of Bukwang, announced that the phase 2b trial for JM-010, a treatment candidate for levodopa-induced dyskinesia (LID) in Parkinson's disease, did not meet its primary endpoint.

In an online briefing, Bukwang CEO Lee Jae-young explained that the company has decided to halt the U.S. clinical trials as well due to the failed European phase 2 b trial.

"We are deeply sorry for not delivering the expected results to those waiting," Lee said. "While we observed a statistical difference in the pre-and post-treatment results of JM-010, it did not show a significant difference compared to the placebo group."

Lee noted that the initial strategy was to expedite the U.S. trials based on positive results from Europe. However, the failure to meet the primary endpoint necessitated a plan change. "Considering the extended timeline for clinical development in the U.S. and its impact on our business viability, we have decided to terminate the U.S. trials."

Despite the setback, Lee stressed that the company remains committed to new drug development and plans to continue exploring promising projects within its pipeline. "Bukwang will shift its focus to another promising drug, CP-012, which is in phase 1 trials in the U.K.," Lee said.

According to Lee, CP-012 targets morning akinesia, a condition experienced by 70 percent of Parkinson's patients, potentially offering a larger market opportunity than JM-010.

"We are not giving up on new drug development," Lee emphasized. We will proceed cautiously with our existing projects and future investments, leveraging partnerships for open innovation." He added that the company's commitment to research and development in the field of neurodegenerative diseases remains unwavering.

During the online briefing, Lee also addressed questions about Contera Pharma's future, especially about its initial public offering.

At Bukwang's March shareholder meeting, OCI Holdings Chairman Lee Woo-hyun indicated that the company will seek an IPO for Contera Pharma in international markets like Hong Kong or Singapore instead of Korea.

Bukwang CEO Lee reiterated that Contera Pharma's direction remains the same despite the recent clinical trial results and assured stakeholders that the company has no plans to sell Contera.

Lee also noted that OCI Holdings' investment strategy in Bukwang, the partner company of Bukwang, would remain steady.

"While we had high hopes for JM-010, OCI Holdings is still committed to exploring the pharmaceutical and biotech sectors as part of its new business ventures," Lee said. "This setback will not alter our overall policy towards Bukwang."