Zemvax, GV1001 Phase 2 Results Released "Confirmed Potential as Alzheimer's Disease Treatment"

[Asia Economy Reporter Hyunseok Yoo] GemVax & Kael (hereinafter GemVax) announced on the 16th that it revealed the successful Phase 2 clinical trial results of the Alzheimer's disease treatment 'GV1001' at the Korean Dementia Association Autumn Academic Conference.

Professor Seongho Ko of the Department of Neurology at Hanyang University College of Medicine, the first presenter at the academic conference held online on the 14th, said, "This clinical trial confirmed the efficacy and safety of GV1001," adding, "If similar results are obtained in the Phase 3 clinical trial, it could become a game changer in the Alzheimer's disease treatment market."

Since August 2017 until September last year, GemVax conducted clinical trials evaluating the safety and efficacy of GV1001 at 12 domestic medical institutions, including Hanyang University Guri Hospital. The trial targeted Alzheimer's disease patients from moderate to severe stages who had been stably taking donepezil, a cholinergic nervous system regulatory drug, for more than three months. GV1001 was administered subcutaneously at doses of 0.56mg or 1.12mg for six months.

Professor Ko explained, "The Severe Impairment Battery (SIB), the primary endpoint commonly used in clinical trials for moderate or higher Alzheimer's disease, showed a 7.11-point difference in the test group administered 1.12mg of GV1001 compared to the control group receiving donepezil alone, confirming an excellent improvement effect. This difference was especially clearer among patients who faithfully completed the entire clinical trial process."

He also stated, "All three groups in the clinical trial showed no serious adverse drug reactions, confirming safety," and "Statistical significance was also confirmed in the secondary endpoint, the Neuropsychiatric Inventory (NPI)."

He emphasized, "Considering all results, GV1001 has sufficient value to proceed to Phase 3 clinical trials," adding, "If the Phase 3 trial confirms results similar to those of Phase 2, it could become a new treatment for severe Alzheimer's disease patients who currently have no treatment options."

Professor Kihyung Park of Gachon University College of Medicine, who chaired the presentation, said, "While developing drugs have been focusing only on early-stage patients, choosing moderate to severe Alzheimer's disease as the indication is a very wise choice," adding, "In a situation where drugs usable for dementia patients with various severities are needed, the upcoming results are highly anticipated."

Additionally, Professor Seunghyun Kim, former president of the Korean Dementia Association, said, "Congratulations on the successful completion of the domestic Phase 2 clinical trial of GV1001," and added, "This result is expected to be an encouraging milestone for dementia clinical physicians in Korea."

A GemVax official stated, "Based on these clinical results, we expect sufficient verification of the drug in the Phase 3 clinical trial."

Meanwhile, GemVax plans to submit the domestic Phase 3 clinical trial plan (IND) for Alzheimer's disease within this year. Alongside this, preparations are underway for clinical trials in the US and Europe, including starting a US clinical trial in the first half of next year targeting moderate Alzheimer's disease patients, for which approval has already been obtained.

This content was produced with the assistance of AI translation services.