AC-100 is a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells. The peptide demonstrated a favorable safety profile in the trial but did not significantly regenerate more periodontal bone versus placebo because the dose evaluated in this study exceeded that which researchers believe may be the optimal dose to effectively treat periodontal disease.
The study enrolled 40 patients in need of periodontal surgery to correct existing periodontal defects. Defects were treated with a single dose of AC-100 or placebo (saline) delivered in a collagen sponge, and patients were followed for six months. The trial assessed the safety of AC-100 and its effect on periodontal bone and other soft tissue regeneration.
“We learned a lot from this initial phase II study and believe additional phase II studies will determine appropriate dosing of AC-100 in the periodontal setting,” said Dr David Rosen, senior vice president of R&D at Acologix. “This novel approach clearly warrants further study in this and related conditions.”
Earlier this year, clinical results of a separate phase II study of AC-100 as a biological approach to treating tooth defects (prepared cavities) were presented at the annual meeting of the International Association for Dental Research (IADR) in Brisbane, Australia. That trial met its primary goal of stimulating the formation of new dentin (the hard tissue of teeth that protects the tooth pulp and supports the outer enamel) when applied directly to tooth defects. AC-100 also demonstrated a favorable safety profile in that study.