Amyndas Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of novel complement therapeutics, announced today the launch of its Phase 2a clinical study, evaluating AMY-101 in adults with periodontal inflammation and gingivitis. AMY-101 is a novel synthetic cyclic peptide designed to inhibit the complement cascade centrally at the level of C3 (Complement component 3).
Periodontitis is a clinical condition involving inflammation of the ligaments and bones that support the teeth. Periodontitis occurs when gingivitis goes untreated and persists. It is a significant cause of tooth loss in adults, and one of the most prevalent diseases worldwide, affecting around 20-50% of the population across the globe. Approximately 743 million people (about 11.2% of the global population) have a severe form of periodontitis that can raise the risk of cardiovascular disease, diabetes, arthritis, and pregnancy complications.
In an earlier Phase I study of AMY-101 in 50 healthy volunteers, AMY-101 was administered systemically and was found to be well tolerated with no serious adverse events. This new phase 2a trial of AMY-101 (ClinicalTrials.gov: NCT03694444) is a 3-month randomized, double-blind, split-mouth study in adults with existing chronic periodontal inflammation, determined by the level of the gingival index and bleeding on probing. In the trial, different halves of the mouth will be randomized (split-mouth design), and AMY-101 or placebo will be injected into the affected gingival tissues, once a week for three consecutive weeks. The primary endpoint of change in the gingival index will be evaluated at 21, 28, and 90 days after initial treatment.
To read the press release in Greek click here.