NEW YORK – NKGen Biotech on Monday said it plans to kick off the Phase II portion of a clinical trial of its cell therapy for moderate Alzheimer's disease, SNK01.
Santa Ana, California-based NKGen is advancing the autologous cell therapy into the Phase II portion of a Phase I/IIa clinical trial after its safety review committee reviewed Phase I clinical trial data, in which three patients received a high dose of the investigational candidate. Investigators found that it was well tolerated without drug-related adverse events.
In an earlier open-label, dose-escalation proof-of-concept Phase I study, investigators found that after four intravenous doses, SNK01 was safe and 90 percent of patients demonstrated improvement or maintained stable cognitive function on the Alzheimer's disease composite score, or ADCOMS. The therapy also reduced levels of various biomarkers, including beta-amyloid, tau, and alpha-synuclein proteins.
In the randomized-controlled Phase II clinical trial, investigators will continue to assess efficacy and safety in a larger group of 30 patients for a year.
NKGen expects to enroll the first patient into the Phase II clinical trial in Q2.
"We are excited to announce another important clinical milestone in our mission to advance SNK01 as the first potential disease modifying treatment of its kind for patients with more advanced Alzheimer's disease," NKGen CEO and Chairman Paul Song said in a statement. Other disease modifying treatments in Alzheimer's have focused on an earlier stage of disease.