JENKINTOWN, PA — SFA Therapeutics, Inc. announced that it recently received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with non-alcoholic steatohepatitis (NASH) with or without fibrosis. SFA-001N is designed to act on multiple pathways involved in the pathogenesis of NASH.
NASH is characterized by accumulation of fat, inflammation, liver cell injury and different degrees of scarring (fibrosis). The condition, which affects between 1.5-6.5% of adults in the U.S., can progress to cirrhosis (liver failure) or liver cancer and is projected to become the leading cause of liver transplantation by 2030. There are currently no FDA-approved therapies for NASH, and investigational therapies targeting specific pathways have had limited success. By acting on multiple molecular pathways simultaneously, SFA-001N has the unique potential to address the inflammatory and fibrotic responses associated with NASH.
“This IND clearance represents a significant milestone for SFA Therapeutics. By expanding our pipeline to a new therapeutic area, we have the opportunity to demonstrate that our novel microbiome-derived drug development platform has the potential to address a wide range of auto-immune and chronic inflammatory conditions in multiple organs,” said Ira Spector, Ph.D., Chief Executive Officer of SFA Therapeutics. “We are grateful to all involved with this regulatory submission and look forward to initiating the study of SFA-001N for NASH and fibrosis patients in Q1 2023.”
In addition to SFA-001N, SFA Therapeutics is investigating SFA-002 in a Phase 1b clinical trial for psoriasis and expects to complete enrollment in early 2023 and share topline data by the end of 2023.
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