SFA Therapeutics Announces FDA Clearance of IND Application for SFA-001N for the Treatment of NASH and Fibrosis

JENKINTOWN, Pa., Jan. 4, 2023 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing new, microbiome-based therapeutics for the treatment of inflammatory diseases, today announced that it has 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.

About SFA Therapeutics

SFA Therapeutics, Inc. is a clinical stage biopharmaceutical company developing microbiome-based therapeutics for the treatment of inflammatory diseases. The company is developing a platform of safer therapeutics based on breakthrough research of the human microbiome, licensed from Temple University. SFA has identified six small molecule drug candidates from this platform, including its lead asset, SFA-002, which has shown promising Phase 1a results and is currently being investigated in a Phase 1b study for psoriasis.

The company's research program is focused on the intersection of chronic inflammation and cancer. Chronic inflammation has been implicated in a wide range of diseases; the SFA pipeline includes targets of psoriasis, hepatocellular carcinoma (the most prevalent form of liver cancer) and NASH, psoriatic arthritis, rheumatoid arthritis, lupus (SLE), inflammatory bowel disease (IBS/IBD), Crohn's disease, and the prevention of relapse/recurrence in AML and CML.

SFA Therapeutics is headquartered in Jenkintown, Pa. Please visit www.sfatherapeutics.com to learn more.

Contact

Ira Spector, Ph.D.
SFA Therapeutics, Inc.
+1 267-584-1080

For Media Inquiries:

David Melamed, Ph.D.
Russo Partners, LLC
[email protected]
212-845-4225

SOURCE SFA Therapeutics, Inc.