Shifa Biomedical Corporation

Shifa Biomedical Corporation (Shifa) is a drug discovery company in Malvern Pennsylvania. It is a privately held biopharmaceutical company dedicated to the cost-effective development of drugs for the treatment of cardiovascular disease. Incorporated in 2006, Shifa has recognized expertise for the discovery of small molecule drugs, utilizing biochemical, cell-based, and virtual screening methods. Shifa exploits molecular biology, biochemistry, crystallography and medicinal, computational and combinatorial chemistry and is led by a highly-experienced team of scientists with extensive expertise in drug discovery and early stage drug development. UNMET NEED Although there have been considerable advancements in developing therapies to lower “bad” cholesterol in the past 25 years, a significant number of patients are either unresponsive or experience concerning side effects with current treatment options, including statins. To address these concerns, more aggressive and selective targeted therapies are needed. One promising avenue for developing specific LDL-C lowering agents is the LDL receptor (LDLR) degradation pathway, which is primarily mediated by the critical regulatory protein known as PCSK9. PCSK9 controls the degradation of the LDLR in the liver and thereby contributes to cholesterol homeostasis. TARGET PCSK9 Several strategies have been tried for targeting PCSK9. Most have focused on the development of injectable biologics. The most successful approach is the injection of monoclonal antibodies (mAb) that interfere with the function of PCSK9. To date, however, no orally bioavailable anti-PCSK9 drug has advanced to the clinic. We have pursued proprietary approaches and identified an orally bioavailable, first-in-class small molecule lead compound, P-21 that interferes with the function of PCSK9. LOWER CHOLESTEROL Shifa’s oral small molecule lead compound significantly lowers LDL-C; it is as potent as the injectable monoclonal antibody.