Otovia Therapeutics

Company news

2023.06.15

Company news

The kick-off meeting for Otovia's "Investigator-Initiated Trial (IIT) on OTOV101N+OTOV101C Injection" was successfully held!

The kick-off meeting for "Investigator-Initiated Clinical Trial (IIT) of OTOV101N+OTOV101C Injection", jointly conducted by Suzhou Otovia Therapeutics Co., Ltd. (hereinafter referred to as "Otovia") and Shandong Second Provincial General Hospital, was successfully held in Shandong Second Provincial General Hospital on June 12, 2023! The IIT aims to preliminarily assess the safety, tolerance, and efficacy of OTOV101N+OTOV101C Injection, a gene therapy product of Otovia, in the treatment of Otoferlin (OTOF) mutation-related deafness. It is planned to recruit 5 subjects and complete the administration for the first subject in July 2023. This IIT has been approved by the Ethics Committee of Shandong Second Provincial General Hospital.



About OTOV101N+OTOV101C Injection:

Regarded as a gene therapy product based on dual-adeno-associated virus (AAV) vector strategy, OTOV101N+OTOV101C Injection is applied to treat OTOF mutation-induced congenital deafness. OTOF protein serves as a vital player in the exocytosis of synaptic vesicles of inner hair cells. In cases of a decrease in the content of OTOF protein on synaptic vesicle membranes, the exocytosis of synaptic vesicles induced by sound stimuli becomes abnormal, resulting in hearing loss. OTOV101N+OTOV101C Injection (ratio: 1:1) can solve the problem that the oversized OTOF gene exceeds the load of a single AAV vector by loading different fragments of the OTOF gene to the same AAV. Through intracochlear injection, the functional OTOF gene is delivered to inner hair cells in patients' cochlea, thus restoring their ability to produce normal OTOF protein. Finally, the physiological hearing of patients is recovered after a single dose.