Neurophth Announces First Patient Dosed in Phase 3 Clinical Trial for the Gene Therapy Treatment of LHON

Neurophth Therapeutics announced that the first patient has been dosed in phase 3 clinical trial for the treatment of Leber hereditary optic neuropathy (LHON). Neurophth is conducting a phase 1/2/3, multicenter, two-part study aimed at evaluating the safety, tolerability, and efficacy of NR082 in LHON patients with ND4 mutations. The investigational new drug (IND) application of NR082 has been approved by CDE on March 29, 2021. Wenbin Wei, vice president of Beijing Tongren hospital affiliated to Capital Medical University, completed the first dose in the phase 3 clinical trial.

"As a clinician, I share the same expectation of LHON patients for effective and affordable treatments," Prof. Wenbin Wei, vice president of Beijing Tongren hospital, CMU, said in a company news release. "NR082 has shown promising safety and efficacy data in all clinical work to date and is officially advanced into a phase 3 trial. Ophthalmic gene therapy is coming of age. We hope that NR082 will be available soon, making a life-changing difference to patients by technological innovation."

Professor Bin Li, Founder, Chairman and CEO of Neurophth, said, " Dosing the first participants in phase 3 trial is a significant milestone of Neurophth and a positive sign of the booming of ophthalmic gene therapy industry. Our team will continue to make every effort to accelerate the clinical trials and commercialization process of China's first ophthalmic gene therapy. We believe that NR082 will have positive results of phase 3 clinical trial, delivering a solution that can transform the lives of LHON patients in return for their years of waiting."