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NKGen Expands Alzheimer’s Research Scope with Health Canada’s Nod

NextEdge Admin

01 Dec 2023

2 min 7 sec

Biotech firm NKGen has received approval from Health Canada to commence a Phase I/IIa clinical trial of its Alzheimer’s disease cell therapy, SNK01. This autologous cell therapy will be evaluated for safety, tolerability, and preliminary efficacy in patients with moderate Alzheimer’s. The company is concurrently conducting clinical trials for SNK01 in Mexico and the US, having recently enrolled its first US patient. In the Canadian trial, the Phase I open-label segment will focus on assessing safety and determining the maximum tolerated dose. Following this, Phase II will be a randomized, placebo-controlled study evaluating both safety and efficacy in patients with moderate Alzheimer’s.

NKGen’s CEO, Paul Song, expressed gratitude for Health Canada’s permission, emphasizing the unique focus on individuals with more advanced Alzheimer’s who lack approved disease-modifying therapies. SNK01 has shown promising results in previous trials, demonstrating good tolerance and a reduction in neuroinflammation. Notably, nine out of 10 patients in a Phase I trial earlier this year exhibited improved or stable cognitive function one week after baseline assessments. The Canadian trial aims to enroll around 36 patients with moderate Alzheimer’s, testing higher SNK01 doses and prolonged dosing schedules compared to the Phase I study in Mexico. NKGen anticipates releasing the first interim data from the Phase I/IIa trial in Q3 2024.