Neurophth Announces First Patient Dosed in Phase I/II Clinical Trial of Second Gene Therapy

Excerpt from the Press Release:

WUHAN, China and SAN DIEGO, Aug. 17, 2023 /PRNewswire/ — Neurophth Therapeutics, Inc. (“Neurophth”) announced today that the first patient has been dosed in the international multi-region, multi-center Phase I/II clinical trial for the treatment of Leber hereditary optic neuropathy caused by ND1 mutation (ND1-LHON).

Neurophth is conducting a Phase I/II, multi-region, multi-center, single-arm, open-labeled, dose-finding study aimed at evaluating the safety, tolerability, and efficacy of NFS-02 in LHON patients with ND1 mutations in both China and the United States. The Investigational New Drug (IND) application of NFS-02 has been approved by the U.S. FDA in December 2022 and has been approved by China National Medical Products Administration (NMPA) on April 17, 2023. Led by Prof. Jia Qu and Rong Zhou from the Eye Hospital of Wenzhou Medical University, the team successfully completed the first dose in the Phase I/II clinical trial.

“Today’s milestone is a significant step forward. NFS-02 is Neurophth’s second gene therapy to enter clinical trials, demonstrating the company’s strong operations.” said Professor Bin Li, Founder, Chairman and CEO of Neurophth, “NFS-02 is currently the only ND1-LHON treatment in development worldwide. In response to patients’ expectations, we are committed to conducting global multi-region, multi-center clinical trials to ensure that it’s on the path towards early drug approval and commercialization in the future.”

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