A novel synthetic cyclic peptide known as AMY-101 reduces inflammation in gingivitis patients, according to Amyndas Pharmaceuticals, which has completed a phase 2 randomized, placebo-controlled clinical trial evaluating its use.
The researchers locally administered AMY-101 to affected gingival tissues in 39 patients with periodontal inflammation and gingivitis once a week for three weeks, achieving reductions in bleeding and gingival inflammation.
Inflammation was resolved in 21 days, and the benefit was maintained for at least 90 days without mechanical treatment, according to the company. Also, AMY-101 was shown to be safe and well tolerated among trial participants.
“We are excited with the robust signal for the efficacy of AMY-101 in these patients,” said Hatice Hasturk, DDS, PhD, director of the Forsyth Center for Clinical and Translational Research, which conducted the trial.
“This is not only a clear POC (proof of concept) of AMY-101 in periodontal diseases, but also a potential paradigm shift in how these diseases can be treated,” Hasturk said.
“Current treatments for periodontal disease are limited to scaling and root planing, while patients with advanced periodontitis treatment may require surgical approaches,” Hasturk said.
“The information gained from this study is very important as it supports a potential new host-modulatory approach that can resolve periodontal inflammation, offering a more effective treatment of periodontal diseases,” said Hasturk.
If left untreated, the researchers said, gingivitis can lead to periodontitis, which is a significant cause of tooth loss in adults that affects 20% to 50% of the worldwide population. About 743 million people are affected with a form of periodontitis, the researchers said.
The complement system has been shown to be involved in periodontal disease and inflammatory bone loss, the researchers said. Activation of the complement component C3 has been shown to fuel gum inflammation, the researchers added, leading to destruction of tooth-supporting bone in preclinical studies in non-human primates.
AMY-101 was designed to inhibit the complement cascade centrally at the level of C3, the researchers said, and local administration was shown to reverse naturally occurring periodontal inflammation in monkeys.
“We were impressed with the prominent therapeutic effect and long-lasting benefit of AMY-101 in the preclinical studies, and Amyndas proceeded to evaluate it in the clinic,” said Dr. John Lambris, inventor of AMY-101 and founder of Amyndas.
“These top-line trial results now show that AMY-101 can indeed attenuate periodontal inflammation in patients and corroborate our hypothesis that it has the potential to become a new standard of care in periodontal treatment, potentially eliminating the need for recurrent invasive periodontal treatments,” said Lambris, who also is the Dr. Ralph and Sallie Weaver Professor of Research Medicine at the University of Pennsylvania.
“We look forward to discussing these results with the US FDA and other regulatory agencies to design the best path forward, ideally through a multi-center phase 3 trial of AMY-101,” said Dr. Despina Yancopoulou, PhD, MBA, Amyndas’ managing director.
“There is a large proportion of the population that suffers from periodontal diseases, and we hope to be able to provide a better treatment option,” said Yancopoulou.
“If successful in phase 3 clinical trials, AMY-101 has the potential to be the first local drug offering a novel mechanism of action for the treatment of periodontal diseases. It is the time to offer clinicians an effective alternative to combat periodontal disease,” said Hasturk.