ORLANDO, Fla. and HAYWARD, Calif.--Acologix, Inc., a privately-held biopharmaceutical company, has announced that a Phase 2 clinical trial of AC-100 (Dentonin), a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells, 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 (prepared cavities).
ORLANDO, Fla. and HAYWARD, Calif.--Acologix, Inc., a privately-held biopharmaceutical company, has announced that a Phase 2 clinical trial of AC-100 (Dentonin), a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells, 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 (prepared cavities).
AC-100 also demonstrated a favorable safety profile. The results were presented in the "Late-Breaking News Session" at the 35th Annual Meeting of the American Association for Dental Research in Orlando.
Each year, more than 200 million dental restoration procedures are performed in the United States. Drilling during these procedures irritates the dental pulp and reduces the dentin layer that protects the pulp, causing pain and sensitivity, and sometimes leading to complications, including tooth loss.
"This Phase 2 clinical study demonstrates that a novel biological approach to dentistry, by modulating normal cell functions to stimulate the innate biological defenses of the tooth, can be introduced as a supplement to routine dental care," said Cornelis H. Pameijer, D.M.D., D.Sc, Ph.D., study author and professor emeritus of prosthodontics at the University of Connecticut School of Dental Medicine.
AC-100 also demonstrated a favorable safety profile. The results were presented in the "Late-Breaking News Session" at the 35th Annual Meeting of the American Association for Dental Research in Orlando.
Each year, more than 200 million dental restoration procedures are performed in the United States. Drilling during these procedures irritates the dental pulp and reduces the dentin layer that protects the pulp, causing pain and sensitivity, and sometimes leading to complications, including tooth loss.
"This Phase 2 clinical study demonstrates that a novel biological approach to dentistry, by modulating normal cell functions to stimulate the innate biological defenses of the tooth, can be introduced as a supplement to routine dental care," said Cornelis H. Pameijer, D.M.D., D.Sc, Ph.D., study author and professor emeritus of prosthodontics at the University of Connecticut School of Dental Medicine.
"What is truly exciting are the many possible uses of AC-100 that could cover a broad range of applications in dentistry."
Phase 2 Study Design and Results
The randomized, double-blind, placebo-controlled trial enrolled 35 patients who were candidates for at least two third-molar (wisdom teeth) extractions.
"What is truly exciting are the many possible uses of AC-100 that could cover a broad range of applications in dentistry."
Phase 2 Study Design and Results
The randomized, double-blind, placebo-controlled trial enrolled 35 patients who were candidates for at least two third-molar (wisdom teeth) extractions.
Patients served as their own controls, with one molar treated with 200 µg AC-100 (applied on days 0, 2 and 4 through the dentin tubules) and the other with a placebo. After two months, the teeth were extracted and evaluated for remaining dentin thickness, new dentin formation, inflammation and necrosis.
Administration of AC-100 resulted in a clear trend in the formation of new dentin compared to placebo. This effect was seen across a wide variety of cavity depths.
Patients served as their own controls, with one molar treated with 200 µg AC-100 (applied on days 0, 2 and 4 through the dentin tubules) and the other with a placebo. After two months, the teeth were extracted and evaluated for remaining dentin thickness, new dentin formation, inflammation and necrosis.
Administration of AC-100 resulted in a clear trend in the formation of new dentin compared to placebo. This effect was seen across a wide variety of cavity depths.
Importantly, the efficacy of AC-100 was seen most dramatically in the deepest cavities (RDT < 0.5 mm), where the clinical utility of the approach is most needed. AC-100 was well tolerated in the study with no increase in inflammatory response, necrosis, pulpitis (inflammation of the pulp) or other complications observed in AC-100-treated teeth compared with placebo-treated teeth.
Importantly, the efficacy of AC-100 was seen most dramatically in the deepest cavities (RDT < 0.5 mm), where the clinical utility of the approach is most needed. AC-100 was well tolerated in the study with no increase in inflammatory response, necrosis, pulpitis (inflammation of the pulp) or other complications observed in AC-100-treated teeth compared with placebo-treated teeth.
No serious adverse events were reported.
"We learned a lot from this trial, and, based on these promising results, plan to meet with the FDA regarding future development as soon as possible," said David M. Rosen, Ph.D., Vice President, Research and Development, at Acologix.
No serious adverse events were reported.
"We learned a lot from this trial, and, based on these promising results, plan to meet with the FDA regarding future development as soon as possible," said David M. Rosen, Ph.D., Vice President, Research and Development, at Acologix.
"Because of its unique hard tissue regenerating properties and pulp-protective effects, we believe that AC-100 could be a promising treatment for patients undergoing a wide range of dental restoration procedures and could change the way that dentistry is practiced in the future."
In addition to dental applications, Acologix is also studying AC-100 for periodontal, oral bone, dental implant and orthopedic applications. Phase 2 study results of AC-100 used in periodontal surgery are expected later this year.
"Because of its unique hard tissue regenerating properties and pulp-protective effects, we believe that AC-100 could be a promising treatment for patients undergoing a wide range of dental restoration procedures and could change the way that dentistry is practiced in the future."
In addition to dental applications, Acologix is also studying AC-100 for periodontal, oral bone, dental implant and orthopedic applications. Phase 2 study results of AC-100 used in periodontal surgery are expected later this year.
