- Plans to support the entire process from test method development to mRNA analysis for Alzheimer's disease treatment developmentGCCL, a clinical trial sample analysis organization, revealed on January 24 that it has entered into an agreement with Cureverse to conduct a Phase 1 clinical trial for the company’s Alzheimer’s disease novel drug candidate, ‘CV-01 (development code name).’
The clinical trial will focus on evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and the impact of food on the bioavailability of CV-01 following oral administration in healthy young adults and the elderly. GCCL will oversee the entire Central Lab process, including the development of assay methods and analyzing four types of messenger ribonucleic acid (mRNA) to explore pharmacodynamic characteristics. Additionally, it will involve sample management, including PBMC separation, and project management, using the cutting-edge analysis platform, ‘Droplet Digital Polymerase Chain Reaction (ddPCR) Device,’ for analysis throughout the trial.
mRNA analysis plays a critical role in monitoring disease progression and assessing treatment efficacy by analyzing gene expression linked to the degeneration of specific nerve cells in neurological disorders such as Alzheimer’s disease. Due to its inherent instability, mRNA required sophisticated technology for precise analysis. For the CV-01 clinical trial, GCCL will conduct the analysis of four distinct mRNA types to support the trial’s investigation.
CV-01, under development by Cureverse, is a novel drug candidate based on a small molecule compound aimed at treating Alzheimer's disease, Parkinson's disease, and epilepsy. It works by modulating the keap1/Nrf2 signaling pathway that regulates neuroinflammation. CV-01 is recognized for its superior metabolic stability compared to existing approved treatments and its strong efficacy in activating the Nrf2 pathway.
Notably, CV-01 has been developed in an oral dosage form, in contrast to the traditional injectable treatments, which greatly enhances patient convenience. Recently, it secured a technology export agreement with the global pharmaceutical company Angelini Pharma.
“At Alzheimer’s disease treatment development requires diverse strategies, CV-01 holds great potential to overcome the limitations of current treatments and deliver strong therapeutic effects,” said Cho Sung-jin, CEO of Cureverse. “We anticipate this collaboration to mark a key milestone in the development of novel drugs for Alzheimer’s disease.”
“Partnering with Cureverse presents a valuable opportunity to demonstrate our company’s expertise in precision analysis,” expressed Cho Kwan-goo, CEO of GCCL. “We are committed to leveraging our advanced analysis technology and extensive experience to ensure the success of the clinical trials and contribute to the development of innovative Alzheimer’s disease treatments,” he added.
Cureverse, founded in October 2021, specialized in the development of innovative novel drugs based on small molecules aimed at treating brain diseases. Established as a research institute company to commercialize technologies from the Korea Institute of Science and Technology (KIST), the company leverages the infrastructure and expertise of the KIST Brain Science Research Institute’s infrastructure and expertise to identify and develop promising drug candidates. Its mission is to offer new treatment options to patients around the world by discovering innovative drugs for neurological conditions.
GCCL is a clinical trial specimen analysis institution that holds full certification in areas of the Ministry of Food and Drug Safety’s Good Clinical Laboratory Practice (GCLP). The company offers customized clinical analysis services that adhere to global standards throughout the entire clinical trial process, from Phase 1 to Phase 4. Leveraging advanced analysis platforms that meet global quality standards, including the introduction of ddPCR equipment, as well as specialized services in specimen analysis and method development, GCCL supports clinical trial specimen analysis not only for Korean pharmaceutical and biotechnology companies but also for partners in the Asian region and around the world.
Source : [The Bio/Kang In Hyo] GCCL and Cureverse collaborate on Alzheimer's disease drug development in clinical trials (https://www.thebionews.net/news/articleView.html?idxno=12394)