기사본문
GENUV, Receives Approval for ALS Phase 1·2a Clinical Studies on a ‘repurposed’ drug candidate
입력 2019-09-30 11:41 수정 2019-09-30 11:41
by Joungmin Cho
▲CEO Sung-Ho Han, GENUV.
GENUV announced on September 19 that it has received approval from the Ministry of Food and Drug Safety for Phase 1·2a clinical studies on its amyotrophic lateral sclerosis (ALS) drug candidate “SNR1611” which is being developed for the treatment of neurodegenerative diseases.
Caused by various factors, ALS is a neurodegenerative disease that destroys motor neurons resulting in symptoms such as muscle twitching and muscle weakness. Currently, there is no cure for ALS, and the average survival time of ALS patients is approximately 3 to 4 years from onset.
Discovered through GENUV’s proprietary drug screening platform “ATRIVIEW” that is specific for neurological disorders, “SNR1611” is a drug candidate that has been repurposed for neurodegenerative disease from a previously approved anti-cancer drug. GENUV has already confirmed SNR1611’s effect of neuron regeneration and functional recovery through preclinical research in Alzheimer’s and ALS animal models.
The approved clinical trial will be conducted on 30 ALS patients in Korea to evaluate the safety, tolerance, and efficacy of SNR1611 therapy compared to the comparator in a dose escalation study Participating sites include Samsung Medical Center, Yonsei Severance Hospital, and Korea University Hospital, and the study is expected to be completed by 2022.
CEO Sung-Ho Han stated, “as we have already identified the activity of a new MoA in ALS treatment such as the normalization of neurons and stimulation of cell production through our preclinical animal studies, we hope to confirm the potential of SNR1611 as a therapeutic treatment for ALS.”
Meanwhile, GENUV is in preparation for the U.S. clinical studies of “SNR1611” for the treatment of Alzheimer’s disease with support from the Korea Health Technology R&D Project, funded by the Ministry of Health & Welfare.
