Shifa is a privately held company dedicated to the development of drugs for the treatment of cardiovascular disease. Shifa has developed an oral, small molecule (P-21), that interferes with the function of PCSK9. P-21 significantly lowers LDL cholesterol; it is as potent as the injectable monoclonal antibody. Being oral, P-21 does not require injection or refrigeration necessary for biological agents like the PCSK9 antibodies Repatha or Praluent. The advantages of an oral small molecule versus an injectable antibody are significant; a small molecule: a) has significantly higher profit margins because of low manufacturing cost, b) can be formulated as a once daily fixed-dose combination with a statin, c) no anticipated immunogenicity, and d) no injection site complications. Furthermore, doctors, patients and payers always prefer oral to injectable. P-21 lowers LDL-cholesterol by about 90% in mice fed high-fat diet when mice are given 30 mg/kg daily doses of the compound for two weeks.
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Antagonist of PCSK9/LDL receptor (P-21)
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