GemVax's 'Alzheimer's Treatment' Accelerates Phase 2 Clinical Trials... Simultaneous Trials in US and Europe Underway

[Asia Economy Reporter Lee Chun-hee] GemVax & Kael is accelerating the Phase 2 clinical trial of 'GV1001,' which is being developed as a treatment for Alzheimer's dementia. Following the initiation of the first patient dosing, the clinical trial scope has expanded globally to include not only the United States but also Europe.

On the 13th, GemVax announced that on the 12th (local time), it received approval for its Investigational New Drug (IND) application from the Spanish Agency of Medicines and Medical Devices (AMPS). Through this, the Phase 2 clinical trial will be conducted globally, simultaneously including the United States, Spain (recently approved), and seven other European countries: France, Italy, Portugal, the Netherlands, Poland, and Finland. The company also stated that IND approval procedures are underway in six other countries.

Accordingly, the recruitment plan for 180 participants in Phase 2, initially expected to be conducted only in the United States, is now expected to proceed with 77 participants in the U.S. and 108 in Europe. A GemVax representative said, "From the early stages of planning Phase 2, we intended to expand the clinical trial to Europe," adding that they plan to proceed with a global clinical trial.

GemVax received approval from the U.S. Food and Drug Administration (FDA) in 2019 for a Phase 2 clinical trial targeting patients with moderate Alzheimer's disease. However, the start of the trial was delayed due to the COVID-19 pandemic. At the end of last year, the FDA approved a clinical trial amendment to expand the target to include patients with mild dementia. On the 5th, the first patient dosing was conducted at the Aventura Neurologic Associates Center in Florida, USA.

This clinical trial targets patients with mild to moderate Alzheimer's disease who have been stably taking the cholinergic nervous system modulator 'donepezil' for more than three months. GV1001 will be administered subcutaneously at doses of 0.56 mg or 1.12 mg for 52 weeks (12 months) to evaluate the efficacy and safety of GV1001. The primary efficacy endpoint is set as the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog).

A GemVax representative stated, "The significance of this European clinical trial lies in establishing a foundation for new drug development in both the U.S. and Europe with a single clinical trial," adding, "We will do our best to complete all procedures in countries where approval is still in progress and to expedite patient recruitment across European countries."

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