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Acologix Presents Preclinical Data Demonstrating Therapeutic Benefit of AC-100 in Bone and Dental Applications at the 27th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR)

Hayward, CA – September 26, 2005 – Acologix, Inc., a privately held biopharmaceutical company, presented preclinical data demonstrating therapeutic benefit in bone and dental applications of its leading skeletal tissue regenerating compound, AC-100 (Dentonin®), during the 27th Annual Meeting of the American Society for Bone and Mineral Research, September 23-27, Nashville, Tennessee, USA. AC-100, a novel synthetic peptide, is being developed for indications related to bone and dentin regeneration. Having completed Phase I safety studies, AC-100 is currently in Phase II development for two indications — one for periodontal bone regeneration and the other for reparative dentin formation. Patient enrollment for both studies has been completed, and results are expected in early 2006.

The first presentation entitled, “AC-100, a Fragment of MEPE, Promotes New Dentin Formation in both Direct and Indirect Pulp Capping Models in Beagle Dogs,” abstract #F461 and #SA461, was presented on September 23rd and September 24th at the ASBMR meeting. The data presented demonstrate that AC-100 stimulates new dentin ingrowth with a notably different mechanism of action from the currently available dental products. Specifically, AC-100 achieves its activity by stimulating new dentin formation while exhibiting reduced local inflammatory and apoptotic responses. This approach could provide important patient benefits in human dental restoration procedures.

The other presentation entitled, “AC-100, a Fragment of MEPE, Promotes New Bone Formation via Enhanced PGE2 Production and Cell Binding to Matrix Proteins,” abstract #SU214, was presented on September 25th. The data presented demonstrate that in an ex-vivo bone culture model AC-100 significantly increases new bone formation, bone cell density and osteoblast cell number. This study indicates that the bone anabolic activity of AC-100 is strongly connected to the potent induction of PGE2 production and the stimulation of cell binding to matrix proteins, both critical aspects of human bone formation.

About Acologix, Inc.

Acologix strives to improve patients’ lives by developing and commercializing innovative biopharmaceuticals targeting “osteo-renal” (bone and kidney) diseases. Acologix’s substantial expertise in identifying and developing therapeutics with unique mechanisms of action (such as mineral metabolism sciences) is key to solving major kidney and bone health problems. Chronic kidney failure, renal osteodystrophy, orthopedics, periodontal disease, general dentistry and oral care represent significant underserved medical needs. Acologix is unique in its focus on these rapidly growing health care problems. Acologix has recently announced the partnership with Toray Industries, Inc. of Japan on the development and commercialization of AC-820, an anti-pruritic agent for the treatment of uremic pruritis in dialysis patients. A European Phase III clinical study is planned for launch in late 2005 and Acologix’s US clinical strategy is under development. Acologix’s leading hard tissue regeneration compound, AC-100 (Dentonin®) is currently under investigation in two Phase II clinical studies in Europe and the United States for the repair of periodontal defects and in dental restorations, respectively. Acologix is also developing AC-200 (Phosphatonin) to treat hyperphosphatemia and its subsequent clinical problems in chronic kidney disease.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix’s business.

Company Contact

Yoshi Kumagai
President and CEO
Phone: 510.512.7200
Fax: 510.786.1116
ir@acologix.com


     
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