NevroGene Announces Completion of Patient Enrollment in U.S. Phase I/II Clinical Trial for Opvika®

On February 19, 2024, Neurophth, a leader in gene therapy for ophthalmic diseases in China (hereinafter referred to as "Neurophth"), announced that the core product of the company, NewVision® (Opvika, Ipevaclis Injection), used for treating Leber's hereditary optic neuropathy caused by ND4 mutations (ND4-LHON), has completed patient enrollment and dosing in the Phase I/II clinical trial in the United States.

Neurophth is conducting a Phase I/II, single-arm, multicenter clinical study in the United States to evaluate the safety and efficacy of gene therapy for ND4 mutation-associated Leber's Hereditary Optic Neuropathy (LHON). The Investigational New Drug (IND) application for this project was approved by the U.S. Food and Drug Administration (FDA) on January 18, 2022, and the first patient was dosed in June 2023.

"We are very grateful for the trust and support of the patients and their families, as well as the participation and dedication of all the researchers, who played a key role in successfully advancing the enrollment for the Phase I/II clinical trial," said Professor Bin Li, Founder, Chairman and CEO of Neurophth. "Neurophth has taken a solid step forward on the path of going global with innovative drugs. In China, For Global – we will strive to bring China's medical research achievements to the world and offer more innovative gene therapies to patients with ophthalmic diseases worldwide."

The Principal Investigator (PI) of this clinical trial, Professor Yaping Joyce Liao from the Byers Eye Institute at Stanford University, stated: "The significant progress achieved in this Phase I/II clinical trial is truly exciting. LHON patients are eagerly awaiting new therapies like Opvika®, which may offer the possibility of a cure. I am very much looking forward to witnessing the results of the Phase I/II clinical trial with Neurophth."

Editor: Muyan

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