The effects of AC-100 on cartilage regeneration were evaluated in goats with standardized medial femoral condylar (knee cartilage) defects. In one study, deep defects in knee cartilage and underlying bone were treated with a collagen sponge containing AC-100 or placebo followed by three weekly intra-articular injections of the test articles into the operated knee joint. Cartilage regeneration was evaluated after three and six months.
In another study, a more superficial knee cartilage defect that did not reach the bone was treated with four weekly intra-articular injections of AC-100 or placebo. In half of the goats in each group, microfracture surgery, used clinically to promote healing, was performed. Cartilage was evaluated after six weeks to investigate early regeneration.
In both studies, AC-100 dose dependently promoted cartilage repair compared to placebo. AC-100 treatment increased cartilage regeneration both with and without microfracture. AC-100 demonstrated a favorable safety profile in the study, with no inflammatory response.
These results suggest that repair of both severe and non-severe knee cartilage defects may be improved with intra-articular AC-100, with or without concomitant microfracture procedures.
Dawn McGuire, chief medical officer of Acologix, said: “Results thus far for cartilage regeneration in experimental injury models, as well as the excellent safety profile of AC-100, provide strong support for initiating clinical development of AC-100 in osteoarthritis and traumatic cartilage injury.”