New Chinese milestone as Zhongmou wins US clearance for trials

Zhongmou Therapeutics, a Chinese genomic medicine company focused on restoring vision through gene and optogenetic therapies, has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin a multinational, randomized, single-masked, sham-controlled clinical trial (PRISM) of ZM-02.

This investigational asset is a mutation-agnostic optogenetic gene therapy for patients with advanced retinitis pigmentosa (RP).

The FDA completed its review in 20 days, faster than the standard 30-day review window, which Zhongmou attributes to the quality, completeness and scientific rigor of the company’s preclinical, chemistry, manufacturing and controls (CMC), and clinical development package.