Date: 2016-12-12
Type of
information: Initiation of development program
phase: 2
Announcement: initiation of development program
Company: C3J Therapeutics (USA - CA)
Product: C16G2
Action
mechanism: peptide/microbiome.
Disease: dental caries
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On December 12, 2016, C3J Therapeutics, a private, clinical stage biotechnology company focused on the development and commercialization of novel therapeutics aimed at reengineering the human microbiome, announced the development of two new formulations of its lead candidate, C16G2, a novel peptide-based drug for the prevention of dental caries (tooth decay).
- In Phase 2 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 upcoming Phase 2 clinical trials.
- 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.
Is
general: Yes
