NVP Healthcare completes FDA Pre-IND meeting for microbiome-based NASH drug

On the 24th, NVP Healthcare, a leader in microbiome-based drug development, announced that it had completed a pre-IND meeting with the FDA ahead of submitting materials for a U.S. Phase 2 clinical trial of NVP-LC2767, a candidate treatment for nonalcoholic steatohepatitis (NASH).

At the meeting, NVP Healthcare and the FDA discussed overall development considerations for the microbiome-based therapy, including process development, manufacturing and quality control (CMC) for the investigational drug, as well as nonclinical and clinical data needed to submit an investigational new drug (IND) application for NVP-LC2767.

Dr. Kim Seong-hye of NVP Healthcare said, “At the pre-IND meeting, we received a positive response from the FDA regarding advancing NVP-LC2767, a microbiome-based NASH treatment, into a U.S. Phase 2 trial.” She added, “This opportunity will help us accelerate clinical development of NVP Healthcare’s microbiome-based drug pipeline.”

No drugs are currently approved worldwide to treat NASH. This reflects a significant unmet need and strong growth potential for the NASH treatment market. The industry expects the market to exceed approximately $30 billion (about KRW 40 trillion) by 2030.

In two clinical trials involving patients with fatty liver disease, NVP-LC2767 significantly improved liver inflammation markers, including ALT, AST and γ-GTP, by regulating the gut-liver axis. In particular, researchers identified a mechanism by which microbiome modulation reduces gut toxins that contribute to fatty liver disease and restores liver function. Compared with existing NASH drug candidates, it is emerging as a new treatment strategy that may address the underlying cause safely, without side effects.

NVP Healthcare plans to submit its Phase 2 IND application materials to the U.S. FDA in the first half of 2024.

NVP Healthcare: https://nvp-healthcare.com/