C3J Therapeutics Unveils Development of Two New Product Formulations
C3J Therapeutics, Inc. recently announced the development of two new formulations of its lead candidate, C16G2, a novel peptide-based drug for the prevention of dental caries.
In Phase II trials conducted in 2016, the company demonstrated that a novel dental varnish formulation containing C16G2 achieved significant reductions of Streptococcus mutans, which is recognized as the major causative agent of dental caries. A single varnish application outperformed multiple tooth gel applications delivered by custom dental tray or by brushing. The varnish formulation of C16G2 is a product candidate for in-office treatment similar to fluoride varnishes commonly applied by dentists or hygienists, and is therefore potentially well-suited for the in-office treatment of high risk, caries prone populations.
Given the efficacy demonstrated to date of this professionally applied product, and recognizing the need for an additional convenient at-home dosing method, C3J Therapeutics has also developed an innovative tooth strip product for delivery of the drug to the tooth surface biofilm. The company has successfully manufactured room temperature stable tooth strips in preparation for the upcoming Phase II clinical trials.
“The clinical results obtained to date demonstrate that tooth surface contact and drug concentration are both key to effective therapy,” said Todd Patrick, President and CEO of C3J Therapeutics. “The trials evaluating the varnish show that this formulation delivers superior microbiology results compared to other applications. We believe that just a few doses of the drug will have the potential to re-engineer the oral microbiome, thereby providing long-term protection. Additionally, we feel the tooth strip formulation has the potential to become a convenient, at-home application for multiple treatments. The excellent safety profile greatly enhances the therapeutic window of this investigational product.”
C3J Therapeutics anticipates initiating clinical trials in the first quarter of 2017 to explore the efficacy of both tooth strips and varnish in commercially relevant treatment paradigms. These studies include evaluation of the varnish applied at a frequency appropriate for populations with high disease burden, and the varnish in combination with tooth strips. The combination of varnish plus tooth strips enables an in-office professional varnish treatment to be followed with self-application of tooth strips at home. Results from the Phase II studies are expected by the third quarter of 2017, and preliminary data will be presented at the International Conference on Anti-Caries Remineralizing Agents (ICNARA) taking place in Napa Valley, CA, from April 30-May 2, 2017.
C3J Therapeutics is a clinical-stage biotechnology company focused on improving human health through the development and commercialization of targeted, pathogen-specific antimicrobials (STAMPs) that treat and prevent human diseases caused by microbial dysbiosis. The proprietary STAMP platform technology has potential applications to a variety of bacterial infections, and disorders, particularly related to the human microbiome. In addition to a Phase II program for dental caries, C3J anticipates advancing a C. difficile STAMP into the clinic in 2017. For more information, visit www.c3therapeutics.com.
Total Page Views: 536