Genosco Submits IND Application to US FDA for Phase 1 Clinical Trial of ROCK2 Inhibitor

Genosco, a subsidiary of the innovative drug development company Oscotec, announced on September 2 that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on August 29 for the initiation of a Phase 1 clinical trial of its ROCK2 inhibitor candidate, GNS-3545, which is being developed as a treatment for idiopathic pulmonary fibrosis.

This clinical trial is an early-stage study designed to evaluate the safety and tolerability of the drug in healthy volunteers. The company expects that this will serve as a foundation for expanding development into a variety of indications in the future. If the IND is approved, Genosco plans to begin the Phase 1 trial within this year.

Genosco's ROCK2 inhibitor candidate, GNS-3545, not only effectively suppressed the expression of key proteins that cause fibrosis, but also demonstrated in preclinical animal studies that it could restore disease-related gene expression to normal levels. A Genosco representative explained, "These results suggest the possibility of recovering damaged lung tissue, and unlike existing treatments that merely slow disease progression, there is hope for a fundamental cure for the disease."

The submission of this IND is particularly significant because Genosco is independently pursuing this clinical trial, drawing on the experience gained from the global out-licensing of lazertinib (brand name Leclaza), which was co-developed with its parent company Oscotec and successfully obtained new drug approvals in the United States, Europe, China, and Japan.

Jongseong Ko, CEO of Genosco, stated, "The initiation of this Phase 1 clinical trial is expected to serve as an important milestone that once again demonstrates Genosco's drug development capabilities. Since this candidate has passed the rigorous internal standards applied to lazertinib, expectations for future results are high."

Meanwhile, Genosco plans to maximize the commercial potential of its pipeline through global clinical expansion, strategic partnerships with overseas pharmaceutical companies, and technology transfers, building on this achievement. The company aims to secure a total of five new drug approvals over the next ten years, with at least one of them being directly commercialized to establish a new growth engine. In addition, Genosco is accelerating the clinical advancement and commercialization of various pipeline assets currently under development, including treatments for cerebral cavernous malformation, targeted protein degraders (TPD), and degrader-antibody conjugates (DAC).