Samsung Pharmaceutical Receives Approval for Phase 3 IND Amendment of Alzheimer's Disease Treatment GV1001

Samsung Pharm announced on the 7th that it has received approval from the Ministry of Food and Drug Safety for the change in the domestic Phase 3 clinical trial plan (IND) of GV1001, an Alzheimer's disease treatment.

The Ministry of Food and Drug Safety accepted Samsung Pharm's application to simplify the GV1001 dosage groups, approving the change in the clinical trial plan from the existing two groups of 0.56mg and 1.12mg to a single group of 1.12mg. With the unification of the dosage group, the number of clinical trial patients will be reduced from 936 to 750, significantly improving clinical convenience.

Samsung Pharm will commence the Phase 3 clinical trial to evaluate the safety and efficacy of GV1001 for Alzheimer's disease treatment.

The clinical trial will involve 750 patients with moderate to severe Alzheimer's disease, administering 1.12mg of GV1001 for 24 weeks (6 months), and will confirm superiority over placebo through the Severe Impairment Battery (SIB) and Clinician's Interview-based Impression of Change-plus (CIBIC-plus) assessments.

Unlike commercialized Alzheimer's disease treatments targeting mild or early-stage patients, GV1001 is being developed for patients with moderate to severe Alzheimer's disease. So far, no side effects or adverse reactions related to the drug have been observed.

GV1001 1.12mg demonstrated a significant effect in slowing the progression of Alzheimer's disease by showing meaningful results in the primary efficacy evaluation variable, the Severe Impairment Battery score, through Phase 2 clinical trials.

In May of last year, Samsung Pharm acquired the domestic license for GV1001 from GemVax & Kael. GemVax is conducting the global Phase 2 clinical trials of GV1001 for Alzheimer's disease in the United States and seven European countries.

A Samsung Pharm official stated, "We can start the Phase 3 clinical trial for Alzheimer's disease domestically," adding, "Having confirmed safety and efficacy in the Phase 2 clinical trial, we will do our best to introduce a differentiated new drug to the Alzheimer's disease treatment market through the Phase 3 clinical trial."