KainosMed "Global Clinical Trials for Parkinson's Disease Treatment Begin in Earnest"

[Asia Economy Reporter Yoo Hyun-seok] Lee Gi-seop, CEO of Kainosmed, said on the 15th, "Receiving approval for the Phase 1b clinical trial of the Parkinson's disease treatment is significant because it means Kainosmed has officially started global clinical trials for the Parkinson's disease treatment (KM-819)."

At the extraordinary general meeting held that day, CEO Lee stated, "We submitted the Investigational New Drug (IND) application for the Phase 1b clinical trial of the Parkinson's disease treatment to the U.S. FDA at the end of October and received approval at the end of November."

He added, "Kainosmed succeeded in developing and introducing a new formulation that significantly improves drug absorption compared to the previous formulation used in the earlier Phase 1 trial. Although there have been criticisms that the schedule was delayed due to the Phase 1b trial, we take pride in having increased the likelihood of success in new drug development through the new formulation."

Kainosmed plans to conduct participant screening until the end of the year and carry out the Phase 1b clinical trial throughout January 2021. It is expected that the IND for the Phase 2 clinical trial can be submitted to the FDA in the first half of next year. For multiple system atrophy, which is an expanded indication from Parkinson's disease, the company plans to submit the Phase 2 clinical trial IND to the Korean Ministry of Food and Drug Safety early next year and expects to start the clinical trial in the first half of the year.

The AIDS treatment being developed by China's Changsu ID is also expected to be available on the market next year. CEO Lee said, "Changsu ID expects NDA approval by early 2021 if no unforeseen major issues arise," and forecasted, "If Changsu ID's sales increase in the future, Kainosmed will also earn royalty revenues of several billion won annually."

Kainosmed plans to enter the global market through a joint venture with Changsu ID. Both companies are focusing on entering emerging markets with the AIDS treatment. In addition to the AIDS treatment, the cytotoxic anticancer agent and epigenetic anticancer agent, which Kainosmed has already licensed to Changsu ID, will also be introduced to the market.

He said, "Kainosmed is striving to increase shareholder value through the clinical development of KM-819, development and sales of the AIDS treatment in emerging markets such as China, and securing additional pipelines. We ask for your continued support even if there are some shortcomings."

Meanwhile, at the extraordinary general meeting held that day, Kainosmed approved as originally proposed the partial amendment of the articles of incorporation, the appointment of directors, and the appointment of auditors.