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SFA Therapeutics Announces FDA Clearance for Amendment to Extend Phase 1b Trial of SFA-002 for Psoriasis

JENKINTOWN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) — SFA Therapeutics, a clinical-stage biotech using a first-in-class immuno-modulation technology platform, announced positive results from their SFA-002 Phase 1b cohort 1 clinical trial. SFA’s oral pill SFA-002 has the potential to be disease-modifying, with durable responses and an excellent safety profile. SFA-002 simultaneously acts on multiple therapeutic pathways, unlike other drugs on the market which target a single channel, and provides an immunomodulatory effect by down-regulating levels of pro-inflammatory cytokines involved in the pathogenesis of psoriasis including TNF-α, IL-23, IL-12, IL-17 and INF-γ, and down-regulating autoimmunity.

The Phase 1b clinical trial of SFA-002 in mild-to-moderate chronic plaque psoriasis is an open label prospective study of 2 different dosage forms, in two cohorts. The study protocol is 12 weeks of active therapy, one month of follow-up and an optional 12 weeks of extension. The primary outcome measure is safety, and the secondary outcomes are the IGA score (International Global Assessment) and Psoriasis Area and Severity Index (PASI) score after study completion.

Cohort 1 Analysis Highlights:


In 14 evaluable subjects (including 6 subjects on the 3-month extension)

  • 85% of patients demonstrated a PASI improvement of greater than 50
  • 71% of subjects showed an improvement of greater than PASI 75
  • Two subjects achieved PASI 100 (100% clearance)
  • Onset of action was observed in as little as six weeks
  • Clinically meaningful treatment effects included patients with difficult to treat scalp psoriasis and palmoplantar psoriasis


  • No related adverse events or toxicities were observed during the treatment period and follow-up, and no rebound effects were observed

The second cohort of the Phase 1b clinical trial is ongoing ( Identifier: NCT05642182). A readout for cohort 2 is expected by year-end 2023. 

According to Dr. Daniel Sauder, past chairman of the Department of Dermatology at the Johns Hopkins School of Medicine and past Chief of Dermatology at the University of Toronto, “SFA-002 is an incredibly safe oral drug with very high efficacy and has the potential to become an important drug in the treatment of psoriasis.”

Psoriasis, an incurable chronic disease that affects 125 million people worldwide, with the global psoriasis treatment market size projected to grow at a CAGR of 9.2%. The current gold-standard treatment for autoimmune disease is single-pathway, injectable immunosuppression. Due to affordability and accessibility, as many as 90% of patients with autoimmune diseases do not take immunosuppressants. Over 30% of patients on immunosuppression therapy do not respond to treatment. Further, the side effects of immunosuppression include susceptibility to infectious diseases such as TB and rare cancers.

About SFA Therapeutics, Inc.

SFA Therapeutics is a clinical-stage biotech using a first-in-class immuno-modulation platform to discover and develop next generation therapies, focused on the treatment of autoimmune diseases. SFA Therapeutics is advancing a focused portfolio of clinical and pre-clinical assets to optimize efficacy and safety in multiple inflammatory diseases, afflicting over 350 million patients worldwide. SFA-002 is the lead asset in the SFA Therapeutics portfolio, serving as a proof-of-concept for SFA’s key mechanism of action aimed at treating a range of autoimmune diseases.


Mike Moyer
LifeSci Advisors

Ira C. Spector, PhD
SFA Therapeutics, Inc.