SFA Therapeutics announced positive results from its Phase 1b clinical trial of SFA-002, an oral drug candidate for patients with mild-to-moderate psoriasis. The trial demonstrated both safety and efficacy, positioning the treatment as a potential new option in a market with limited oral therapies.
The Jenkintown, Pennsylvania-based company reported that SFA-002 successfully met its primary endpoint of safety, with no treatment-related adverse events or toxicities observed during the treatment period. Additionally, no rebound effects were noted following treatment, and the company has filed its annual safety update with the U.S. Food and Drug Administration.
Efficacy Data Shows Promise
Beyond safety, SFA-002 also achieved its exploratory efficacy endpoints. Patients receiving the drug showed statistically significant improvements in both Psoriasis Area and Severity Index (PASI) percentage change and Investigator Global Assessment (IGA) scores compared to those receiving placebo.
The trial was structured with two cohorts to evaluate different formulations of the drug. According to company officials, the Cohort 2 formulation demonstrated particularly promising results, which will be the focus of upcoming Phase 2 clinical trials.
"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," said Stefan C. Weiss, MD, Chief Medical Officer of SFA Therapeutics.
Addressing an Unmet Need
The development of SFA-002 targets a significant gap in the current psoriasis treatment landscape. According to the company, mild-to-moderate patients represent over 80% of all plaque psoriasis cases, yet effective oral treatment options for this population remain limited.
Current treatments for psoriasis often involve topical therapies, which can be inconvenient and show limited efficacy, or injectable biologics, which are typically reserved for more severe cases and can cause immunosuppression.
"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," explained Ira Spector, PhD, Chief Executive Officer of SFA Therapeutics.
Mechanism of Action
SFA-002 functions as an IL-10 up-regulator in immune cells. Interleukin-10 (IL-10) is an anti-inflammatory cytokine that plays a crucial role in preventing inflammatory and autoimmune pathologies. By increasing IL-10 production, SFA-002 aims to reduce the inflammatory response that drives psoriasis symptoms without broadly suppressing the immune system.
This mechanism represents part of SFA Therapeutics' broader platform of oral small-molecule biosynthetic compounds developed for inflammatory and autoimmune diseases. The company's technology is based on research licensed from Temple University that focuses on tailoring patented formulations with target-specific adjuvants.
Looking Toward Phase 2
With these positive Phase 1b results, SFA Therapeutics is preparing to advance the Cohort 2 formulation of SFA-002 into Phase 2 clinical trials for mild-to-moderate psoriasis. The company has not yet announced a timeline for the initiation of these trials.
Beyond SFA-002, the company is also developing SFA-001N for Metabolic Dysfunction-associated Steatohepatitis (MASH), formerly known as Non-alcoholic Steatohepatitis (NASH). The FDA has cleared the Investigational New Drug (IND) application for this compound, allowing clinical investigation to proceed.
As the company advances its pipeline, it continues to focus on developing safer and more efficacious treatments for chronic inflammatory and autoimmune diseases through its novel approach to immune regulation.
