(Yicai Global) Nov. 18 -- China's first gene therapy for congenital hearing loss will begin clinical trial next month.
Chinese biotech startup Rrgener Therapeutics is expected to enroll the first patients to test the therapy next month in collaboration with Eye & Ent Hospital of Fudan University, Yicai Global learned at the ongoing International Biopharma Industry Week Shanghai 2022.
The therapy, designed to restore or improve the defective gene that causes hereditary deafness, administers recombinant drug RRG-003 in a minimally invasive, one-time manner to repair the patient's hearing, Liu Xinxing, general manager at the Shanghai-based company, told Yicai Global.
RRG-003 has been fully evaluated for safety and efficacy in animal tests, was approved by the Chinese Ethics Committee, and was registered with relevant watchdogs.
Rrgener plans to recruit two or three pediatric subjects nationwide for the trials.
Every year, around 30,000 newborns in China suffer from hearing loss, 60 percent of which is caused by genetic factors.
Globally, there are no marketed gene therapy drugs for congenital deafness. In the second half of this year, two US genetic companies, Akouos and Decibel Therapeutics, received the go-ahead for clinical trials from the US Food and Drug Administration.
Editor: Martin Kadiev