SFA Therapeutics, Inc is a clinical-stage, platform-based biotech with a novel immunomodulatory platform focused on chronic inflammatory diseases. Our vision is to change Medicine. SFA is developing small molecule oral drugs that have been shown to regulate the immune system through a complex cascade that affects several important molecular pathways, downregulating NF-kB and RAS. This platform has led to the development of six drugs to treat immuno-inflammatory diseases, targeting psoriasis and liver diseases (Hepatitis B, NASH and Hepatocellular Carcinoma (HCC), the most common form of liver cancer. SFA?s most advanced assets are SFA001 and SFA002, which is in phase 1b.
Our lead drug, SFA002, is being developed to treat autoimmune diseases, and the first proof of concept is in psoriasis. This drug is currently targeted at the mild-moderate patients for whom the risk of taking monoclonal antibody drugs is too great, yet who are poorly served by current treatments. SFA002 is an oral drug that simultaneously downregulates key channels that have been proven to work in psoriasis, including TNF, IFN and IL17. The FDA has provided a direct regulatory path to a phase 2A clinical trial. We have an approved IND, and phase 1b clinical trial is currently underway and recruiting patients in mild-moderate psoriasis, a market that has significant unmet need. There are over 85 million patients with this condition, and current therapies are not very good for these patients.
SFA001 has been shown to prevent Hepatitis B from progression to hepatocellular carcinoma (HCC), a disease that affects 370 million patients and causes approximately 900,000 cancer deaths annually. There are no current treatments that prevent the progression of hepatitis B to liver cancer- until SFA001. SFA001 works by blocking fibrosis, which is a key contributor to the pathophysiology of NAFLD, NASH and liver cancer, and has also been shown to inhibit the growth of two most prevalent forms of human liver cancer. We have received Orphan Drug Status from the FDA for this drug.
We have received 7 patents and have 26 patents pending in 12 countries, with patent protection until 2035.
SFA has research programs in other autoimmune and inflammatory diseases, including uveitis, bullous pemphigus, cytokine release syndrome, and in preventing the recurrence of chronic lymphocytic leukemia (CLL), for which there is no current treatment. A spinout from Temple University in Philadelphia, SFAs discovery labs include transgenic colonies of animals with human diseases, enabling rapid translational research to be performed.