Zemvax "Resubmits Alzheimer's Disease Clinical Plan After Addressing Rejection Reasons"

[Asia Economy Reporter Hyunseok Yoo] GemVax & Kael (hereinafter GemVax) announced on the 22nd that the Ministry of Food and Drug Safety rejected the approval application for the Phase 3 clinical trial plan of GV1001, which is being developed as a treatment for Alzheimer's disease. The company plans to supplement the reasons for rejection and reapply as soon as possible.

GemVax had applied for approval of a Phase 3 clinical trial plan on January 27 to evaluate the efficacy and safety of subcutaneous administration of GV1001 at 0.56 or 1.12 mg/day in patients with severe Alzheimer's disease. The trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, prospective study. Subsequently, the company prepared and submitted related materials through two rounds of supplementation. However, the company explained that the application was rejected due to insufficient data on some items.

The Ministry of Food and Drug Safety, in the rejection letter sent to GemVax the day before, requested that "the number of subjects to be recruited be recalculated based on the rationale for the number of patients" and that "superiority over the control drug for both primary endpoints be demonstrated in the description."

A GemVax official stated, "As this is the first time a domestically developed new drug is challenging a Phase 3 clinical trial for dementia treatment, we fully anticipated that the process would not be easy," and added, "We will actively accept the Ministry's opinions, sufficiently supplement the application, and reapply promptly to obtain approval for the Phase 3 clinical trial."

Meanwhile, through the Phase 2 clinical trial, GemVax confirmed a remarkable improvement in the Severe Impairment Battery (SIB) score and statistical significance in the Neuropsychiatric Inventory (NPI), as well as demonstrated the safety of the drug. The detailed results of this Phase 2 clinical trial were recently published in the prestigious journal Alzheimer’s Research & Therapy.