GenEditBio stepped into the biotech competition in 2021 with one goal and mission in mind to serve vivo genome-editing therapeutic solutions. The company now excitedly declared that its IND (Investigational New Drug) application has received a clean chit by the U.S. Food and Drug Administration (FDA). This application was for permission to conduct Phase 1/2 CLARITY trial activities to strengthen and take a leap in its in vivo genome-editing program GEB-101 for TGFBI corneal dystrophy.
The Phase 1/2 CLARITY trial will be conducted to prove the efficacy, tolerability and safety of GEB-101, with its data convincing to corneal dystrophy patients with TGFBI mutation. The study is built in a patternized way, making it sequential, easy, acceptable and multicentered, suitable for the reason behind this study. The participants involved in this trial will be injected with one intrastromal of GEB-101. The registration of the patients will take place in the second half of this year on the site's full development in the U.S.
Co-Founder, Chairman of GenEditBio, PhD, Zongli ZHENG, said, “This clearance has cleared a pathway for the popular clinical asset, GEB-101. This is a moment for us that reflects our dedication to introducing a transformative ribonucleoprotein (RNP) related quick degradation editor to accomplish in vivo genome-editing therapy. The therapy with little off-target editing challenge and peak-specific tissue editing for all over universal patients.”
“This milestone shows the sincere initiatives accompanied by the whole staff and the company to modernise the preclinical assets to the clinical level with professionalism, speed and stringent behaviour and rules bound to the trial and other operations.”
Co-Founder and CEO of GenEditBio, PhD, Tian ZHU, said, “GEB-101 is a reliable, comprehensive investigational genome-editing therapy for TGFBI corneal dystrophy. For now, there’s a shortage of treatment options that do not identify the main cause, which disappoints many individuals, leaving them unattended of targeted genetic approach.”
“This recent clearance evaluates our comprehensive preclinical data on efficacy and safety. We are awaiting the trial site activation, and the intention to position the CLARITY trial globally is also a major goal that will help us enter the major markets.”
Learning about the GEB-101 program, which stands tall and confident on the CRISPR-Cas genome-editing technology, is a key development calling for a positive shift and ethical confirmation to prove the potential of the program and its promise.
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
