2. Academic Validation
  3. Safety and Efficacy of the Complement Inhibitor AMY-101 in a Natural Model of Periodontitis in Non-human Primates

Safety and Efficacy of the Complement Inhibitor AMY-101 in a Natural Model of Periodontitis in Non-human Primates

  • Mol Ther Methods Clin Dev. 2017 Aug 18;6:207-215. doi: 10.1016/j.omtm.2017.08.001.
Tetsuhiro Kajikawa 1,  Ruel A Briones 2,  Ranillo R G Resuello 3,  Joel V Tuplano 3,  Edimara S Reis 4,  Evlambia Hajishengallis 5,  Cristina A G Garcia 2,  Despina Yancopoulou 6,  John D Lambris 4,  George Hajishengallis 1
Affiliations

Affiliations

  • 1 University of Pennsylvania, School of Dental Medicine, Department of Microbiology, Philadelphia, PA 19104, USA.
  • 2 Manila Central University, College of Dentistry, 1400 Caloocan City, Metro Manila, Philippines.
  • 3 Simian Conservation Breeding and Research Center (SICONBREC), Makati City, Philippines.
  • 4 University of Pennsylvania Perelman School of Medicine, Department of Pathology and Laboratory Medicine, Philadelphia, PA 19104, USA.
  • 5 University of Pennsylvania, School of Dental Medicine, Department of Preventive and Restorative Sciences, Division of Pediatric Dentistry, Philadelphia, PA 19104, USA.
  • 6 Amyndas Pharmaceuticals, 16675 Glyfada, Greece.
PMID: 28879212 DOI: 10.1016/j.omtm.2017.08.001
Abstract

Periodontitis is a chronic inflammatory disease associated with overactivation of the Complement System. Recent preclinical studies suggest that host-modulation therapies may contribute to effective treatment of human periodontitis, which may lead to loss of teeth and function if untreated. We previously showed that locally administered AMY-101 (Cp40), a peptidic inhibitor of the central complement component C3, can inhibit naturally occurring periodontitis in non-human primates (NHPs) when given once a week. This study was undertaken to determine the local safety of increasing doses of the drug as well as its efficacy when given at a reduced frequency or after systemic administration. Our findings have determined a local dose of AMY-101 (0.1 mg/site) that is free of local irritation and effective when given once every 3 weeks. Moreover, a daily subcutaneous dose of AMY-101 (4 mg/kg bodyweight) was protective against NHP periodontitis, suggesting that patients treated for systemic disorders (e.g., paroxysmal nocturnal hemoglobinuria) can additionally benefit in terms of improved periodontal condition. In summary, AMY-101 appears to be a promising candidate drug for the adjunctive treatment of human periodontitis, a notion that merits investigation in human clinical trials.

Keywords

AMY-101; complement; compstatin; inflammation; non-human primates; periodontitis.

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