C3 Jian has initiated the first Phase II clinical study for its C16G2, which selectively targets a cavity-causing organism Streptococcus mutans, under its US Food and Drug Administration investigational new drug (IND) application.
A synthetic peptide derived from C3 Jian’s pheromone signaling platform technology referred to as STAMPs (specifically targeted antimicrobial peptides), C16G2 targets the specific elimination of Streptococcus mutans.
C3 Jian’s STAMP technology has potential applications to a variety of diseases and disorders particularly related to bacterial and fungal infections.
STAMP technology has the ability to identify peptide sequences that specifically target most types of bacteria.
Streptococcus mutans is believed to be a critical factor in the cause of dental caries or tooth decay. C16G2 is being developed for the prevention of dental caries in adults, adolescents and pediatrics.
The Phase II study is a randomised, double-blind, safety and microbiology study in healthy adult subjects.
The primary objective of the placebo-controlled, four arm, Phase II clinical study is to further build on the safety profile of C16G2 administration in both dental gel and mouth rinse dosages.
It will also focus on targeting antimicrobial activity of these applications by measuring the reduction of Streptococcus mutans, as well as the total bacteria in dental plaque and saliva.
With proper safety, the company expects to extend the Phase II programme to assess C16G2 in children.
C3 Jian president and CEO Todd R Patrick said: "The advancement of the Phase II clinical programme for C16G2 is a testament to our development team’s talent and the potential of the STAMP technology platform."
C3 Jian anticipates to complete the Phase II study in late-2014.
In August 2013, C3 Jian announced successful completion of a Phase I clinical trial related to C16G2. The randomised Phase I study was conducted at New York University’s, Bluestone Center for Clinical Research.
The Phase I study was a double-blind, placebo-controlled study that included a dose escalation period.
The study focused on evaluating safety and pharmacokinetics, along with initial microbiology of C16G2 administered to healthy adults in a single oral dose of mouth rinse.
No C16G2 related events, and no severe or serious adverse events were reported in the study.
Image: A gram stain image of Streptococcus mutans. Photo: courtesy of BetacommandBot.