Gemvax & KAEL said that it had received approval from the Ministry of Food and Drug Safety for a phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with moderate to severe Alzheimer's disease.

The company plans to conduct a multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective, phase 3 study to evaluate the efficacy and safety of subcutaneous administration of GV1001 0.56 or 1.12 mg/day in patients with moderate to severe Alzheimer's disease. About 50 hospitals and 936 Alzheimer patients will participate in the study.

The trial's primary endpoint is the change in the severe impairment battery and clinical dementia rating-sum of the box after 24 weeks of administration of GV1001 compared to the baseline.

The clinical trial consists of a double-blind phase for 24 weeks and an open extension phase for 24 weeks after that.

GemVax conducted a phase 2 clinical trial of GV1001 at 12 medical institutions from August 2017 to September 2019, confirming its safety and effectiveness in moderate to severe Alzheimer's disease patients.

Based on the results, it applied for approval for a phase 3 clinical trial plan on Jan. 27 last year. However, regulators rejected the company's application due to insufficient data for some items. The company supplemented the data, re-applied on June 24, and received approval.

"Since the mid-2021, we have been discussing the phase 3 clinical trial with several neurologists positively evaluating the results of phase 2 clinical trial," a company official said. "We believe patient recruitment will start soon.

She added that the company would mobilize all its capabilities to derive the best results in the shortest time.