Phase IIa clinical trial of complement C3 inhibitor AMY-101 in adults with periodontal inflammation.

ABSTRACT: BackgroundGingivitis and periodontitis are prevalent inflammatory diseases of the periodontal tissues. Current treatments are often ineffective or do not prevent disease recurrence. Uncontrolled complement activation and the resulting chronic gingival inflammation are hallmarks of periodontal diseases. We determined the efficacy and safety of a complement 3-targeted therapeutic, AMY-101, which was locally administered to adult patients with periodontal inflammation.MethodsThirty-two patients with gingival inflammation were enrolled in a randomized, placebo-controlled, double-blind, split-mouth phase IIa trial that followed a dose escalation study to select a safe and effective dose in an additional 8 patients. Half of the patient's mouth was randomly assigned to AMY-101 (0.1 mg/site) or pl

SUBMITTER: Hasturk H 

PROVIDER: S-EPMC8631591 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature