The domestic biotechnology company Ensol Biosciences announced on the 1st that it has confirmed the protective effect of the blood-brain barrier on its developing Alzheimer's disease treatment candidate 'M1K (Moriah 1000)' in animal experiments. Based on this, the company plans to enter clinical trials involving humans next year.
The blood-brain barrier (BBB) serves as a barrier to filter out bacteria and foreign substances contained in the blood in the process of supplying nutrients and oxygen to the brain. However, in the case of Alzheimer's patients, this barrier is compromised, causing toxic substances to invade and accelerating cognitive decline.
According to Ensol Biosciences, the company confirmed the increase of the BBB-related biomarker 'ZO-1' through long-term administration of M1K in experiments using the Tg2576 mouse model, an Alzheimer's animal model.
The company explained that the results show the potential for M1K to slow disease progression in the early stages of Alzheimer's. M1K is a peptide-based treatment candidate that can be delivered to the brain. It works by blocking the RAGE receptor pathway, which is highly expressed in the brains of Alzheimer's patients, thereby inhibiting oxidative stress and inflammatory responses due to amyloid beta accumulation.
Earlier, it was said that M1K showed improvements in cognitive function and memory retention in other animal models, and its effects on BBB stabilization and inhibition of neuroinflammation were confirmed.
Ensol Biosciences plans to conduct early clinical trials targeting patients in the mild cognitive impairment (MCI) stage. The company stated, "We are currently finalizing the clinical trial design based on the research results and toxicology data accumulated over the past eight years," and added, "We expect to submit the clinical trial application (IND) to the Ministry of Food and Drug Safety as early as early next year, but at the latest by mid-year."
Kim Hae-jin, CEO of Ensol Biosciences, said, "M1K is the core new drug candidate that the company has been researching for a long time to overcome Alzheimer's disease," and noted, "We will prove the cognitive recovery effect confirmed in animal experiments in human clinical trials and pave the way for curing the root of Alzheimer's disease."