SFA Therapeutics Reports Positive Phase 1b Data for SFA-002 in Psoriasis

SFA Therapeutics, Inc., a biopharmaceutical company based in Jenkintown, Pennsylvania, has announced encouraging results from its Phase 1b clinical trial involving the oral drug candidate SFA-002 for treating mild-to-moderate psoriasis. This trial marks a significant step forward in the development of therapies for inflammatory and autoimmune diseases.

The Phase 1b trial's primary aim was to evaluate the safety of SFA-002, and it successfully met this goal. Throughout the treatment period, patients did not experience any treatment-related adverse events or toxicities. Additionally, there were no signs of rebound effects after stopping the treatment. This positive safety profile has been documented in the company's annual safety update filed with the U.S. Food and Drug Administration.

Aside from safety, the trial also explored the drug's efficacy. Patients treated with SFA-002 showed statistically significant improvements in both the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA) scores compared to those given a placebo. These tools are standard measures for assessing the severity and coverage of psoriasis and the overall disease severity, respectively. The study included two different cohorts to assess distinct formulations of the drug.

Dr. Stefan C. Weiss, the Chief Medical Officer of SFA Therapeutics, expressed optimism about the results, particularly those from Cohort 2. He remarked that the safety and efficacy data indicate that SFA-002 could have a substantial effect in alleviating psoriasis symptoms in the upcoming Phase 2 clinical trial. Dr. Weiss emphasized that their approach to immune regulation aims to provide a safer and more effective oral treatment for psoriasis sufferers.

Ira Spector, PhD, the Chief Executive Officer of the company, highlighted that over 80% of psoriasis cases are mild-to-moderate, and there are limited oral treatment options available for these patients. SFA-002 is believed to fill this treatment gap with its oral administration and targeted, non-immunosuppressive strategy. Spector expressed enthusiasm about advancing to the next phase of clinical trials, particularly focusing on the successful formulation from Cohort 2.

SFA Therapeutics is grounded in innovative research licensed from Temple University and is working on developing small-molecule biosynthetic compounds aimed at treating chronic inflammatory and autoimmune diseases. The company’s platform technology is designed to tailor the effects of specific formulations to optimize treatment safety and efficacy. SFA-002, an IL-10 up-regulator, has shown promise in early clinical trials and is now moving towards Phase 2 trials for psoriasis.

Moreover, SFA Therapeutics has received FDA clearance to begin investigating another compound, SFA-001N, for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), also known as Non-alcoholic Steatohepatitis (NASH), with or without fibrosis. This initiative indicates the company's broader commitment to addressing various inflammatory and autoimmune conditions.

As SFA Therapeutics continues to make advancements in its clinical programs, it remains focused on providing new, effective treatment options for patients with difficult-to-treat diseases. The company is poised to contribute significantly to the biopharmaceutical field with its innovative therapeutic approaches.