US-based biotherapeutics company Noveome has commenced the Phase II clinical trial of its new secretome, ST266, to treat patients with moderate to severe periodontitis.
The randomised, double-blind, placebo-controlled Phase II trial is designed to assess the safety, efficacy, and treatment regimen of topical ST266.
The trial is focused on the primary endpoint in determining the change from baseline in pocket depth evaluated after three months of treatment.
The secondary endpoint focuses on determining the same after administering the patients with the treatment regimen for nine months.
Harvard School of Dental Medicine and Forsyth Institute Thomas Van Dyk said: "An essential goal for intervention in periodontitis is the return of tissue homeostasis.
"Conventional interventions such as root planing offer a temporary benefit in removing bacterial etiologic agents, but such procedures incompletely address the unregulated inflammation that is responsible for tissue damage in periodontal diseases."
Periodontitis is a severe inflammatory condition causing damage of the soft tissue and destruction of the bone that supports the tooth.
According to recent data, more than 47% of adults or 65 million people in the US are afflicted with periodontitis.
ST266 is composed of a rich, complex solution of molecules secreted from proprietary cells, which are made available in sufficiently low levels to avoid negative effects.
It is characterised by a range of functions such as modulates inflammation, speeds impaired wound healing, promotes bone restoration, restores nerve function and promotes nerve repair, regenerates cells ensuring a safety profile.
Image: Radiograph displaying bone loss between the two roots of a tooth signifying periodontitis. Photo: courtesy of Bernard bill5~commonswiki.