SFA Therapeutics recently announced the completion of enrollment for its phase 1b clinical trial (NCT05642182) assessing SFA-002, an oral treatment for mild to moderate plaque psoriasis. Initial data from the first patient cohort (n = 14) indicate encouraging results: 92% of patients experienced a reduction in the Psoriasis Area and Severity Index (PASI) by more than 50% from baseline, 72% saw a reduction by over 75%, and two patients achieved a complete clearance (PASI 100).
Promising Early Results
Dr. Stefan Weiss, MD, MBA, who was recently appointed as the chief medical officer at SFA Therapeutics, discussed the trial’s promising early outcomes and the potential impact of SFA-002 on psoriasis patients in an interview with Dermatology Times.
A Patient-Centered Approach
SFA-002 works by modulating the immune system, specifically down-regulating pro-inflammatory cytokines such as TNF-α, IL-23, IL-10, IL-12, IL-17, and INF-γ. “This oral therapeutic is crucial because most psoriasis patients currently require injectable medications, and a pill is generally preferred,” said Weiss.
Meeting Clinical Benchmarks
Weiss highlighted the impressive success observed in the early trial phases. “SFA-002 has demonstrated high efficacy in early phase trials. The response, particularly in achieving PASI 75 clearance, has been remarkable,” he stated. This level of response is essential for progressing to further trial phases and eventually making the treatment widely available.
The company also emphasizes the safety profile of SFA-002 as a significant advantage. “It boasts an exceptionally robust safety profile,” noted Weiss. “Ensuring patient safety is paramount when prescribing medication for immunologic diseases like psoriasis.”
Rigorous Evaluation Metrics
The trials have adhered to strict evaluation metrics, focusing on patient responses as measured by PASI 75—a key benchmark for FDA evaluation of psoriasis treatments. Other metrics include the time to response and the percentage of patients achieving PASI 90 and PASI 100.
Inclusive and Comprehensive Trials
Inclusivity in clinical trials is critical for a condition as prevalent as psoriasis. “Our goal is to ensure we capture all patient demographics because psoriasis affects both genders and various ethnic groups,” Weiss explained. Understanding the drug’s effectiveness across diverse populations is essential for its success.
Addressing Psoriasis and Metabolic Syndrome
Psoriasis is often associated with metabolic syndrome, worsening the condition. “Psoriasis contributes to metabolic syndrome and can trigger cardiac events, particularly in individuals with obesity,” Weiss stated. SFA-002 aims to address these complexities by modulating the immune response without the high immunogenicity seen with specific cytokine inhibitors.
Next Steps and Future Prospects
The phase 1 trial is nearing completion. “We will finalize this phase 1 trial to lock and analyze the full dataset,” Weiss concluded. “Once we have a comprehensive understanding of the results, we will initiate the phase 2 protocol.” The next phase will involve collaboration with the FDA, selecting appropriate sites, and recruiting investigators to ensure a thorough evaluation of SFA-002 in a broader psoriasis patient population.
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