C3 Jian completes second phase 2 clinical trial of anticavity drug
July 13, 2015
C3 Jian, Inc., a biotechnology company focused on reengineering the human microbiome to deliver novel health-care products, announced it has preliminary data in a current phase 2 clinical trial for its novel drug, C16G2. C16G2 targets the specific elimination of Streptococcus mutans (S. mutans), the acid-producing bacterium associated with dental caries or tooth decay.ADDITIONAL READING | Product candidate to target specific elimination of Streptococcus mutans may alter oral microbiome to provide long-lasting benefits C16G2 is the first peptide therapeutic derived from C3 Jian’s proprietary platform technology referred to as STAMPs (Specifically Targeted Antimicrobial Peptides). The STAMP technology specifically targets pathogenic bacteria to correct dysbiosis of microbiome communities. The result is a microbiome reengineered to restore a balanced ecology with the potential for lasting therapeutic benefit.ADDITIONAL READING |Increasing dental case acceptance through the use of salivary diagnostics C3J15-201B-00 was a phase 2 dose trial that evaluated the activity of C16G2 dental gel in two convenient modes of application. Fifty-two subjects were enrolled and received C16G2 doses applied via toothbrush and dental tray for one week with a one-week follow-up visit. The primary objective was safety, with pharmacokinetics and microbiology as secondary objectives. The trial identified a viable dose and mode of application where subjects’ S. mutans levels were rapidly reduced and remained low, even after cessation of therapy, indicating a lasting impact on the microbial community. Further, this trial demonstrated a strong safety profile and no systemic absorption for C16G2, extending observations from prior phase 1 and phase 2 trials.ADDITIONAL READING |Understanding and managing peri-implant bone loss “We are extremely pleased that the trial data further reinforces the activity of C16G2 gel product delivered by dental tray and toothbrush. Our next clinical trial will determine the durability of this treatment to finalize the optimal schedule. On the horizon are potential product extensions that broaden market reach by delivering the drug via toothpaste and an in-office varnish, expected to be in the clinic by early 2016. Our ultimate objective is to demonstrate a reduction in dental caries in phase 3, and to have a diverse product line that will allow us to bring this revolutionary drug to millions of people,” said Todd R. Patrick, C3 Jian’s president and CEO.ADDITIONAL READING |Does your dental extraction socket need a bone graft: A decision matrix The target indication for C16G2 is the prevention of dental caries in adults, adolescents, and pediatrics. According to the Centers for Disease Control and Prevention, dental caries, also known as tooth decay or cavities, is the most common chronic childhood disease. In the US alone, more than $100 billion is spent annually on oral health expenditures covered by insurance. The majority of these expenses are directly related to dental caries. For more information about C3 Jian, Inc., visit their website.
