Date: 2011-05-11
Type of information:
phase: 1
Announcement: initiation
Company: Santaris Pharma (Denmark)
Product: SPC4955
Action mechanism: SPC4955 is a mRNA-targeted drug candidate that inhibits apolipoprotein B (apoB), a major protein component involved in the formation of low density lipoprotein cholesterol (LDL-C) or “bad” cholesterol. It has been developed using Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform.
Disease: high cholesterol
Therapeutic area: Cardiovascular diseases
Country:
Trial details: The randomized, dose-escalation, double-blind, placebo-controlled Phase 1 study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of SPC4955. The study aims to enroll 30 healthy volunteers who will be randomized to receive either subcutaneous injections of SPC4955 or placebo. In preclinical studies, SPC4955 potently and dose-dependently inhibited the synthesis of apoB resulting in significant and durable reductions in plasma levels of LDL-C and triglycerides.
Latest news: Santaris Pharma has advanced a second drug from its cardiometabolic program, SPC4955 into Phase 1 clinical trials, for the treatment of high cholesterol. Santaris Pharma also announced it had advanced another drug candidate, SPC5001, a mRNA-targeted drug inhibiting the synthesis of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), for the treatment of high cholesterol into Phase 1 clinical trials. PCSK9 is a protein involved in removing low density lipoprotein cholesterol (LDL-C) or “bad” cholesterol from the bloodstream. SPC4955 aims to inhibit the production and export of LDL-C in the liver while the other clinical candidate SPC5001, increases the clearance of LDL from the blood.
