Neurophth Therapeutics, Inc., a China-based in-vivo gene therapy company for ophthalmic diseases, announced on Monday that it has enrolled its last subject in the phase one/two clinical trial of Opvika (Esonadogene Imvoparvovec) intended for the treatment of Leber hereditary optic neuropathy caused by ND4 mutation (ND4-LHON).
The company is carrying out a Phase I/II, single-arm, multi-centre study that is intended to assess the safety and efficacy of NR082 in LHON subjects with ND4 mutations in US. The US Food and Drug Administration approved the Investigational New Drug (IND) application for NR082 on 18 January 2022 and the first patient was dosed in June 2023.
Professor Li Bin, Neurophth founder, chairman, and CEO, said, 'We are extremely grateful for the trust and support of patients and their families, as well as the dedication of all researchers. They have played a crucial role in the successful completion of patient enrolment for the Phase I/II clinical trial. Neurophth has taken a solid step forward in going global. As our motto is 'In China, for global', we will strive to bring China's medical development and more innovative gene therapies to patients worldwide.'
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Tabelecleucel BLA
Bavarian Nordic's chikungunya vaccine receives validation from EMA for accelerated review
Atara Biotherapeutics gains FDA Priority Review for tabelecleucel
Hyperfine secures FDA clearance for faster brain imaging software
Silo Pharma agrees Alzheimer's drug licence
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation
Camurus reports positive Phase 3 ACROINNOVA 2 results
Acurx Pharmaceuticals presents positive Ibezapolstat Phase 2 clinical trial results for CDI