AC-100

AC-100, or Dentonin^® is the most advanced program in hard tissue regeneration area at Acologix. AC-100 has shown to promote formation of new hard tissues such as bone, cartilage, and dentin in vitro and in vivo. Acologix is pursuing multiple clinical applications of AC-100 in hard tissue area including dental and orthopedic areas. A couple of Phase II studies have been completed in dental area and additional Phase II studies are planned for orthopedic applications. In an earlier Phase I study with healthy volunteers, AC-100 was well tolerated with a very high safety margin.

Dental Applications
AC-100 was tested in two Phase II clinical studies in dental field. One of them was for the treatment of dental defects and AC-100 clearly demonstrated to stimulate formation of new dentin, the hard tissue in a tooth, by simple topical application into the dental defects in a typical tooth restoration procedure. The other study was to treat periodontal disease by regenerating alveolar bone in the periodontal defects. Although AC-100 failed to show the improvement in this study, it was suggested that that an optimal dose may not have been used in this study. With an alternative dose in a pre-clinical tooth extraction model study, AC-100 has exhibited regeneration of high quality bone in the defect.

These data will guide future development of AC-100 for dental applications including common dental defect treatments, placement of dental implants, and regeneration of alveolar bones and ligaments in the periodontal defects. Approximately 160 million common dental restoration procedures, 57 million crown placements, and over 2 million periodontal surgeries are performed every year in the United States, according to the American Dental Association. A novel therapy to regenerate hard tissues such as bone and dental tissues may benefit many of the patients undergoing these procedures.

Orthopedic Applications
Acologix is also developing AC-100 as a therapy to improve the healing of orthopedic bone and/or cartilage defects. Clinical trials are planned following additional preclinical safety and efficacy studies. Approximately 50 million bone fractures occur worldwide each year, including over 6 million in the United States.