Samsung Pharm announced on November 10 that, in relation to the results of the global Phase 2 clinical trial for Alzheimer's disease announced by GemVax & KAEL on November 7, it will actively participate in the commercialization-stage development as the domestic license holder if a global Phase 3 trial is pursued.
Previously, GemVax demonstrated superior safety compared to existing treatments and statistical significance in the secondary endpoint, the Quality of Life-Alzheimer's Disease (QoL-AD) questionnaire, in its global Phase 2 clinical trial targeting patients with mild to moderate Alzheimer's disease. Based on the results of both the domestic Phase 2 and this global clinical trial, GemVax revealed its plan to proceed with a global Phase 3 clinical trial.
Samsung Pharm holds the exclusive domestic license for the development and commercialization of GV1001 as an Alzheimer's disease treatment. The company is preparing for a domestic Phase 3 clinical trial targeting patients with moderate to severe Alzheimer's disease.
If GemVax includes Korea in the global Phase 3 clinical trial, Samsung Pharm expects that the indication could be expanded from mild to moderate, and from moderate to severe Alzheimer's disease.
By participating in a global-scale Multi-National Clinical Trial (MNCT) beyond the domestic market, Samsung Pharm expects to achieve the 'mutual benefit' of strengthening its clinical capabilities by obtaining data at the multi-national clinical trial level for submission to the Ministry of Food and Drug Safety in the future. Compared to conducting a Phase 3 clinical trial independently, participating in a global trial would allow the company to achieve greater cost efficiency by investing less in clinical expenses while still conducting a global clinical trial.
In the case of Biogen, among the 1,795 patients enrolled in the global Phase 3 clinical trial (Clarity AD) for its Alzheimer's treatment Leqembi, 129 were from Korea (out of 294 from all of Asia), accounting for less than 10% of the total.
A Samsung Pharm official stated, "With GemVax's results, we have secured scientific evidence to expand the indication of GV1001 to early-stage Alzheimer's disease," and added, "If Korean patient data are included not only in domestic clinical trials but also in global Phase 3 data, it could be advantageous in shortening the approval process and review period by utilizing global data when applying for product approval."
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