NKMAX, a Korean natural killer (NK) cell-based immunotherapy company, said Tuesday that its U.S. affiliate, NKGen Biotech, has completed dosing the first patient in its phase 1/2a Alzheimer's disease clinical trial of SNK01, an NK cell therapy for Alzheimer’s disease, in the U.S.

In October last year, NKGen Biotech received FDA approval for the phase 1/2a Alzheimer's clinical trial of SNK01.

The first patient enrolled in the U.S. trial, who was suffering from moderate Alzheimer's, was dosed at a maximum dose of 6 billion SNK01, 50 percent higher than the previous maximum dose of 4 billion in the Mexican phase 1 study.

The company did not disclose detailed information of the patient such as age or sex.  

The study will explore the safety and efficacy of up to 6 billion doses of SNK01 in a total of 17 times in 36 patients with moderate Alzheimer’s disease.

The trial is expected to last more than a year, NKMAX said.

In October last year, NKGen announced the final results of its phase 1 Alzheimer's clinical trial on patients with mild symptoms in Mexico at the Clinical Trials on Alzheimer's Disease conference (CTAD) in Boston, MA. 

Based on the results of the phase 1 study in Mexico, the FDA allowed NKGen to continue the phase 1/2a study without preclinical studies in the U.S.

"We are pleased to have dosed the first patient in the U.S. phase 1/2a Alzheimer's clinical trial with SNK01," said Paul Song, CEO of NKGen Biotech. "Our current therapies can be used in mild Alzheimer's disease, so we are focusing on moderate disease for which there is no treatment."

With a total of 17 doses at a high dose of up to 6 billion, the company expects SNK01's long-term immunomodulatory effect in the brain to produce positive results in Alzheimer's disease, he added.