KainosMed "Full-Scale Development of Brain Disease Treatment Through US Subsidiary"

[Asia Economy Reporter Jang Hyowon] Kainosmed announced on the 8th that after listing on the KOSDAQ market, it will intensify the development of 'CNS drugs' through its U.S. subsidiary.

Lee Gisub, CEO of Kainosmed, stated in a shareholder letter posted on the company’s website that "we will accelerate the development of CNS drugs, including a Parkinson's disease treatment, through our U.S. subsidiary Fascinate Therapeutics."

First, the company plans to make every effort to become the first domestic company to enter Phase 2 clinical trials in the U.S. for a Parkinson's disease treatment. Kainosmed’s KM-819, being developed as a Parkinson's disease treatment, inhibits FAF1, a protein that promotes cell death, thereby preventing neuronal cell death. It also activates autophagy functions to promote the degradation of alpha-synuclein and inhibit its aggregation, thus acting as a disease-modifying therapy that halts the progression of Parkinson's disease. Currently, Parkinson's disease treatments only provide temporary symptom relief, which often comes with side effects such as resistance and depression caused by drug exhaustion.

Kainosmed plans to conduct Phase 2 clinical trials in the U.S. for the Parkinson's disease treatment through its U.S. subsidiary, which has received a $25 million investment from a U.S. biotech-focused venture capital firm. The company is collaborating with Dr. Carolyn Ballow, a world-renowned expert in Parkinson's clinical development and a member of Kainosmed’s Scientific Advisory Board (SAB), the U.S. Parkinson’s Institute (PICC), a leading Parkinson's research institution, and the CNS team of the contract research organization (CRO) Parexel to reduce uncertainties and increase the success potential of KM-819’s Phase 2 trials.

CEO Lee expressed confidence, saying, "We will continue to expand indications for KM-819 to synucleinopathies, neurodegenerative diseases caused by abnormal accumulation of alpha-synuclein, such as multiple system atrophy (MSA), thereby increasing the drug’s value." The company plans to conduct Phase 2 clinical trials for MSA at Asan Medical Center in Korea in the second half of this year.

MSA is a movement disorder similar to Parkinson's disease but progresses rapidly and is considered an incurable disease for which Parkinson's treatments are almost ineffective. The life expectancy is only about 5 to 7 years. The number of MSA patients is estimated to be about 5 to 10% of Parkinson's disease patients.

He added, "Since MSA is a rare disease, the overall clinical development period is expected to be shorter than that for Parkinson's disease. We anticipate that the results will serve as a predictive basis for the success of Parkinson's disease treatment development. Conditional approval after Phase 2 completion may also be possible."

The AIDS treatment drug KM-023, currently in Phase 3 trials in China, recently completed the final dosing for the 48-week double-blind patient group. Kainosmed’s Chinese partner, Jiangsu Idea, has started preparations for the new drug application (NDA) this summer, aiming to begin sales in 2021?2022. Once sales commence, Kainosmed will receive royalty revenues.

CEO Lee stated, "With the listing on the KOSDAQ market, Kainosmed will strive with the determination of a 're-start.' We plan to pursue stable profits not only through new drug development but also by entering the healthcare business via mergers and acquisitions (M&A)." He added, "We will do our best to reduce uncertainties in the business one by one and grow to share the fruits with our shareholders."

This content was produced with the assistance of AI translation services.