Naivek Demonstrates Safety in Developing Next-Generation MASH Therapy for Hepatocyte Regeneration

The U.S. Food and Drug Administration (FDA) has approved the world's first treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH), drawing attention to companies developing related new drugs. On the 22nd, Naivek announced that it confirmed the safety of its next-generation MASH treatment under development through preliminary toxicity tests.

Naivek's MASH treatment is based on cell reprogramming specialized in regeneration and shows excellent effects in reducing liver fibrosis. Through cell reprogramming, it not only reduces inflammation and fat accumulation in liver tissue but also eliminates fibrosis. The company explained that this mechanism differentiates it from existing MASH treatments targeting GLP (a hormone that increases insulin secretion) or FGF (fibroblast growth factor, a type of hormone).

MASH, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), causes normal liver cells to transform into fibroblast-like cells when liver tissue is damaged. Fibroblasts excessively produce fibrous proteins, leading to liver fibrosis and cirrhosis. Naivek's MASH treatment achieves cell reprogramming that regenerates fibroblasts back into normal liver cells by reducing the epithelial-mesenchymal transition (EMT) biomarker through peptides.

Naivek confirmed the effects of suppressing liver fibrosis and inflammation in animal model experiments induced by a methionine-deficient diet conducted by a global Contract Research Organization (CRO) and the 'STAM' animal model that induces fatty liver formation. After sample production, preliminary toxicity tests conducted at a GLP-certified institution showed no safety issues.

A Naivek representative said, "The MASH treatment currently under development has demonstrated efficacy in suppressing liver fibrosis and inflammation in various animal model tests, proving its effectiveness in treating MASH caused by multiple factors," adding, "We will accelerate clinical entry after securing clinical samples, pharmaceutical manufacturing (CMC), and safety test data."

He continued, "Naivek's MASH treatment not only has a differentiated mechanism based on cell reprogramming but also can be co-administered with drugs of other mechanisms, which has attracted significant interest from global big pharma," emphasizing, "We will actively target the global MASH market, estimated at 34 trillion KRW, through rapid development achievements."

On the 14th, the FDA approved 'Rezdiffra' (active ingredient Resmetirom), developed by the U.S. biotech company Madrigal Pharmaceuticals, as the world's first MASH treatment. Rezdiffra is an oral drug taken once daily, and its efficacy in resolving MASH and reducing liver fibrosis was confirmed in a Phase 3 clinical trial involving 1,750 subjects.

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