Posted by Michael Wonder on 17 Jul 2022
China CDE grants breakthrough therapy designation to Neurophth's NR082 in Leber's hereditary optic neuropathy
15 July 2022 - Neurophth Therapeutics today announced that the Center for Drug Evaluation of China National Medical Products Administration has granted a breakthrough therapy designation to the Company's leading gene therapy drug candidate, NR082 (rAAV2-ND4), for the treatment of Leber's hereditary optic neuropathy associated with mtND4 mutation.
NR082 (rAAV2-ND4), a recombinant adeno-associated viral vector, serotype 2, containing human ND4 codon optimised gene under the control of the cytomegalovirus promoter and enhancer, is a novel gene therapy product that is being developed for the treatment of Leber hereditary optic neuropathy associated with mtND4 mutations.
