Today, GemVax & KAEL (hereinafter referred to as GemVax) announced that the results of the company’s active Phase 2 clinical trial of the company’s research therapy GV1001 for the treatment of patients with Alzheimer’s disease were published in the journal Alzheimer's Research & Therapy.
GV1001 is a telomerase modulator.
Based on the positive Phase 2 clinical results, GemVax plans to conduct a Phase 3 clinical trial in South Korea later this year.
Alzheimer's disease (AD) is the most common neurodegenerative disease in the elderly.
In 2019, there were more than 35 million patients worldwide, and most of them were elderly people over 60 years old.
AD not only deprives them of their memories, but also severely affects their cognition and self-care ability.
It not only has a profound negative impact on the individual patients, but also on their families, communities, and countries.
However, in the field of AD therapy development, since 2003, the US FDA has not approved any innovative drugs for the treatment of AD.
GV1001 is a polypeptide composed of 16 amino acids, which corresponds to the catalytic site fragment of human telomerase reverse transcriptase (TERT).
TERT is an important part of telomerase and is very important for regulating the activity of telomerase.
Previous studies have shown that GV1001 can prevent nerve cells from being affected by neurotoxicity, and prevent cell apoptosis and damage to nerve cells caused by reactive oxygen species generated by amyloid and oxidative stress.
Therefore, GemVax scientists believe that it may become an option for the treatment of Alzheimer's disease.
In a randomized, double-blind, placebo-controlled phase 2 clinical trial, a total of 96 Alzheimer's disease patients received placebo or different doses of GV1001 treatment.
The primary endpoint of the trial is the evaluation of patients using a scoring system called SIB (severe impairment battery).
The test results showed that after 24 weeks of treatment, the SIB scores of patients treated with higher doses of GV1001 were significantly improved compared with the placebo group.
This improvement can also be observed after 12 weeks of treatment.
In terms of safety, the safety of GV1001 is the same as that of normal saline.
▲SIB score changes of patients treated with different doses of GV1001 or placebo, orange is the highest dose GV1001 treatment group, dark blue is the control group (picture source: reference )
GemVax has submitted an IND application to the Korean regulatory agency, seeking to initiate a phase 3 clinical trial to test the efficacy of GV1001.
At the same time, the company has also received FDA approval to conduct phase 2 clinical trials in the United States to treat patients with mild Alzheimer's disease.
 GemVax's highly promising Phase II Alzheimer's disease clinical trial results targeting telomerase published in prestigious Alzheimer's Research & Therapy' journal.
Retrieved March 30, 2021, from promising-phase-ii-alzheimers-disease-clinical-trial-results-targeting-telomerase-published-in-prestigious-alzheimers-research--therapy-journal-301258354.
 Seong-Ho Koh, et al.
Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial .
Alzheimer's Research & Therapy, https://doi.