Gemvax & Kael said that it presented the results of phase 2 clinical trial for GV1001 that treats Alzheimer's disease, at the Clinical Trials of Alzheimer's Disease (CTAD) conference in San Diego, Calif., on Wednesday.
|Gemvax & KAEL headquarters in Seongnam, Gyeonggi Province.|
The company conducted the phase 2 clinical trial in 12 medical institutions in Korea from August 2017 to September 2019 on 96 patients with moderate and severe Alzheimer's disease who had been taking donepezil, a cholinergic neuromodulator, for more than three months.
Afterward, the company prescribed either GV1001 0.56 mg or GV1001 1.12 mg to evaluate the safety and efficacy of GV1001 for six months.
The primary endpoint was severe impairment battery (SIB) versus baseline at 24 weeks. SIB is known to be a commonly used indicator to assess patients' cognitive function and behavioral behavior in moderate to severe Alzheimer's disease.
As a result, the SIB score decreased 7.23 points in the control group while the GV1001 1.12 mg and donepezil group showed only a 0.12 point decrease, indicating a high improvement effect compared to the control group.
"This improvement suggests little progression of disease during the treatment period in the test group," said Professor Koh Seong-ho from Hanyang University College of Medicine and lead investigator of the study. "This is an encouraging result confirming the possibility of a new therapeutic agent in the absence of new drugs that inhibit progression in patients with moderate to severe dementia."
A company official also said, "We are delighted to see the encouraging results of GV1001 as a treatment for dementia in this trial and believe that the trial results will be a good start to developing the drug."
The company will do its best to speed up and progress the clinical trial, he added.