The candidate, CPG 52364, is a small molecule toll-like receptor (TLR) antagonist designed to specifically inhibit TLRs 7, 8 and 9 and inhibit disease development in systemic lupus erythematosus (SLE) and other autoimmune disorders. CPG 52364 has been designed to interfere at an early stage of the immune cascade by blocking the inappropriate immune activation of all three of these TLRs, and to treat the underlying cause of the disease without causing general suppression of immune function.
The Phase I study is a double-blind, placebo-controlled, randomized clinical trial designed to examine the safety, tolerability and pharmacokinetics of ascending doses of CPG 52364. The compound will be administered as a single oral dose in approximately 40 healthy volunteers.
Robert Bratzler, president and CEO of Coley Pharmaceutical, said: “Coley is committed to innovation in TLR therapeutic drug development, and we are pleased to have furthered our objective of pipeline diversification by advancing this first-in-class TLR antagonist compound into the clinic.
“We believe there is solid preclinical evidence and strong scientific rationale that validate CPG 52364 for the treatment of SLE, and potentially other autoimmune diseases, such as rheumatoid arthritis and psoriasis, where TLRs 7, 8 and 9 are inappropriately activated.”