Korean drugmakers step up development of Alzheimer‘s disease treatment

[Image source: Gettyimagesbank]

South Korean pharmaceutical companies are expected to actively engage in the development of Alzheimer’s disease treatment following the U.S. Food and Drug Administration’s recent approval of Leqembi (lecanemab-irmb), a novel drug developed jointly by the U.S. Biogen Inc. and Japan’s Eisai Co.

According to Korea’s Ministry of Food and Drug Safety on Monday, Eisai submitted an application for the approval of Leqembi last month. Leqembi is an antibody directed against aggregated soluble and insoluble forms of amyloid beta, an abnormal protein, in the brains of Alzheimer’s patients and is administered intravenously once every two weeks.

Local companies are also speeding up the development of Alzheimer’s disease treatment.

Cell therapy developer NKMAX Co. will present interim results of its Phase I clinical trial of SNK01, an intravenously administered cell therapy for Alzheimer’s disease, at the Alzheimer’s Association International Conference (AAIC 2023) in Amsterdam, the Netherlands, from July 16 to 20.

“While Leqembi is a drug that delays Alzheimer’s symptoms, SNK01 improves Alzheimer’s symptoms by activating the brain’s immune function,” said an unnamed official from NKMAX. “We are conducting research to treat solid cancers such as stage IV non-small cell lung cancer and tyrosine kinase inhibitor-refractory NSCLC in addition to Alzheimer’s.”

Samsung Biologics Co. recently announced that it will supply new blockbuster drugs including Alzheimer’s treatments from its fifth plant in Songdo District, Incheon, which is scheduled to start operations in April 2025.

Alzheimer’s treatment is a blockbuster product that will require mass production once the first treatment is available as the number of Alzheimer’s patients is expected to grow, according to Kevin Sharp, vice president and head of Samsung Biologics America–Sales, at the 2023 BIO International Convention held in Boston last month.

In 2020, Samsung Biologics signed a contract development organization (CDO) partnership with Aprinoia Therapeutics Inc., a Taiwanese biotech venture engaged in the development of Alzheimer’s treatments.

AriBio Co., a company developing new drugs for degenerative brain diseases, began Phase 3 clinical trials of its oral dementia treatment candidate AR1001 in the U.S. in November last year and filed a global Phase 3 clinical trial plan for AR1001 with the Korean drug ministry in June.

“AR1001 is a multi-mechanism oral treatment that focuses not only on removing the toxic protein amyloid beta but also on activating brain cognitive functions, including synapse activation and enhancing cerebral blood flow,” said an official from AriBio. “It was recently designated as a project eligible for public interest clinical trial support by the Korea National Enterprise for Clinical Trials under the Ministry of Health and Welfare.”

Celltrion Inc. launched Donerion Patch, a skin-applied donepezil treatment for Alzheimer’s disease, in Korea in August last year. It is a patch-type treatment to be applied twice a week and offers convenient and stable administration as it is absorbed gradually through the skin.

GemVax & KAEL Co. recently signed a technology transfer agreement with Samsung Pharm Co. for the domestic clinical development and commercialization rights of Alzheimer’s treatment GV1001 and is conducting global Phase 2 clinical trials in the U.S. and seven European countries.

The government is also providing increased support for treatments of dementia including Alzheimer’s.

The Ministry of Science and ICT finalized its fourth basic plan for promoting brain research last month, revealing a goal of creating 10 specialized companies with a corporate value of 1 trillion won ($769.2 million) in the brain industry by 2027 and securing two domestic drugs for major brain diseases such as autism and dementia.