SFA Therapeutics Announces Positive Phase 1b Data of SFA-002 in Mild-to-Moderate Psoriasis

Subjects demonstrated statistically significant improvements in Psoriasis Area and Severity Index (PASI) and Investigator Global Assessment (IGA) scores

JENKINTOWN, Pa., March 7, 2025 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel oral small-molecule biosynthetic compounds for the treatment of inflammatory and autoimmune diseases, today announced positive data from its Phase 1b clinical trial of oral drug candidate SFA-002 in patients with mild-to-moderate psoriasis.

SFA-002 met its primary endpoint of safety in the Phase 1b clinical trial. No treatment related adverse events or toxicities were observed during the treatment period, and no rebound effects were observed. SFA Therapeutics has filed its annual safety update with the U.S. Food and Drug Administration.

SFA-002 met its exploratory endpoint of efficacy. Patients administered SFA-002 demonstrated statistically significant Psoriasis Area and Severity Index (PASI) percentage change and Investigator Global Assessment (IGA) score improvements compared to placebo. PASI is a tool used to measure the severity and extent of psoriasis while IGA is a standardized rating system of patient disease severity. The study was designed in two cohorts, to evaluate two different formulations.

"Based on the especially promising safety and efficacy results from patients with mild-to-moderate psoriasis in Cohort 2 of our Phase 1b clinical trial, we are confident that SFA-002 will demonstrate a meaningful impact in mitigating the symptoms of psoriasis in our anticipated Phase 2 clinical trial," remarked Stefan C. Weiss, MD, Chief Medical Officer of SFA Therapeutics. "Our tailored approach to immune regulation holds promise in providing a safer, more efficacious oral treatment for patients suffering from psoriasis."

"Mild-to-moderate patients represent over 80% of all plaque psoriasis cases, and for these patients, current effective oral treatment options are limited. Our belief is that SFA-002 is uniquely positioned to address this gap with an oral route of administration and a targeted, non-immunosuppressive approach," said Ira Spector, PhD, Chief Executive Officer of SFA Therapeutics. "We look forward to the opportunity to investigate the Cohort 2 formulation of SFA-002 in patients with mild-to-moderate psoriasis in a Phase 2 clinical trial."

About SFA Therapeutics

SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory and autoimmune diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory and autoimmune diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, an IL-10 up-regulator in immune cells, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also 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 Metabolic Dysfunction-associated Steatohepatitis (MASH), also known as Non-alcoholic Steatohepatitis (NASH), with or without fibrosis.

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

Company Contact

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

Media Contacts

Tony Russo, Ph.D.
Russo Partners, LLC
[email protected]

Maddie Stabinski
Russo Partners, LLC
[email protected] 

SOURCE SFA Therapeutics, Inc.