LOS ANGELES, Sept. 9, 2014 (GLOBE NEWSWIRE) -- C3 Jian, Inc., a private company focused on providing improved oral healthcare, announced today that it has successfully completed the initial Phase 2 Clinical Trial for its novel drug, C16G2. The Company's drug targets the specific elimination of Streptococcus mutans, the acid producing bacterium associated with dental caries or tooth decay.
C16G2 is the first peptide therapeutic derived from C3 Jian's proprietary, pheromone signaling platform technology referred to as STAMPs (Specifically Targeted Antimicrobial Peptides). C3 Jian's STAMP technology has the ability to specifically target and kill most types of pathogenic bacteria.
The Phase 2 clinical trial focused on determining the most effective formulation and mode of application of the drug. The multi-armed, double-blinded, placebo-controlled study compared mouth rinse and gel formulations, with gel applied by manual toothbrush, electric toothbrush and upper and lower dental trays. Efficacy was assessed by measuring the targeted reduction of Streptococcus mutans. Results from this clinical study demonstrated that gel was the preferred formulation. Further, the study showed clear superiority of the C16G2 gel when delivered via custom dental trays. Subjects in the dental tray cohort achieved an average of a 90% reduction of Streptococcus mutans from baseline after one week of treatment. The reductions lasted until the end of the study, or 7 days post treatment. In the combined placebo group, the levels of Streptococcus mutans did not demonstrate the decrease observed in the active treatment groups but increased over baseline levels. Additionally, the study showed an acceptable safety and tolerability profile of the drug.
"Completing this Phase 2 clinical trial is an exciting and important milestone for C3 Jian. We were able to determine that the amount of time that the drug has in contact with the plaque is important to specifically eliminating S. mutans. We will study this further in our Phase 2b clinical trial that will also explore dose-ranging. Additionally, we will look at microbiology for longer periods post-treatment to better examine durability of the response," said Todd R. Patrick, C3 Jian's President and CEO. "We are very satisfied that this study shows us that a daily (or nightly) tray treatment or an infrequent treatment protocol, such as a few days a month, will work to specifically reduce S. mutans. We are quite willing to go to an efficacy study with such a product profile, given that there are already millions of people in the U.S. alone that routinely wear dental trays for a variety or reasons. Further, we see potential product extensions by delivering the drug via toothpaste, varnish and other formats that allow sufficient contact time. So the bottom line is that the results are very encouraging and strongly affirm the direction we are headed with C16G2 and our overall STAMP technology platform."
The indication for C16G2 is the prevention of dental caries in adults, adolescents and pediatrics. According to the U.S. Surgeon General, dental caries, also known as tooth decay or cavities, is rated the most common chronic childhood disease. In the U.S. alone, over $100 billion is spent annually on oral health expenditures covered by insurance. The majority of these expenses are directly related to dental caries.
"These results are extremely encouraging," stated Dr. Wenyuan Shi, Co-Founder/Chief Scientific Officer of C3 Jian and Chairman of Oral Biology at the University of California, Los Angeles (UCLA). "Our initial idea of formulating the drug into a mouth rinse really didn't show any long term effect on Streptococcus mutans. Seeing the results of the drug in a gel, delivered by a manual toothbrush and especially in a dental tray are very impressive. To see notable and specific reductions of Streptococcus mutans seven days after ending all treatment is exciting. It would appear we have modified the microbiome, which may lead to long lasting protection beyond the treatment window. We are looking ahead to subsequent clinical testing to further demonstrate this effect."
About C3 Jian, Inc.
C3 Jian is a clinical-stage biotechnology company developing and commercializing novel products to diagnose, treat and prevent diseases related to the human microbiome, with an initial focus on improving oral health. C3 is advancing proprietary targeted solutions, which can offer more selective, efficacious and safer treatment modalities than broad spectrum antibiotics. The Company's platform cell signaling STAMP technology has potential applications to a variety of diseases and disorders particularly related to bacterial and fungal infections. C3 Jian is based in Los Angeles, California. For more information about the company, please visit www.c3-jian.com.
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Source:C3 Jian, Inc.