Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
C16G2 Varnish · 1 trial · 1 indication
Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken at screening, baseline (Visit 3/Day 0) and Visits 4 and 5.
| Arm | Type | Description |
|---|---|---|
| Arm 1A: 27.2 mg C16G2 | ACTIVE_COMPARATOR | Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications. |
| Arm 1B: 27.2 mg Placebo | PLACEBO_COMPARATOR | Subjects in Study Arm 1 will receive up to 1 mL of 27.2 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications. |
| Arm 2A: 13.6 mg C16G2 | ACTIVE_COMPARATOR | Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications. |
| Arm 2B: 13.6 mg Placebo | PLACEBO_COMPARATOR | Subjects in Study Arm 2 will receive up to 1 mL of 13.6 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications. |
| Arm 3A: 54.4 mg C16G2 | ACTIVE_COMPARATOR | Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications. |
| Arm 3B: 54.4 mg Placebo | PLACEBO_COMPARATOR | Subjects in Study Arm 3 will receive up to 1 mL of 54.4 mg C16G2 Varnish or Placebo Varnish on day 1, followed by two additional applications a week and two weeks later, for a total of 3 study drug applications. Study drug will be administered via a small brush typically used in varnish applications. |
| Name | Type | Description |
|---|---|---|
| C16G2 Varnish | DRUG | Antimicrobial Peptide |
| Placebo Varnish | DRUG | Placebo |
Inclusion Criteria: 1. Males and females, 12-75 years of age 2. Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent 3. Female subjects of childbearing potential must ...
C16G2 Varnish is an investigational small molecule being developed for dental caries, commonly known as tooth decay. It is formulated as a varnish for topical application to teeth. The drug is currently in clinical development and has not been approved by the FDA.
C16G2 Varnish is being developed by Armata Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ARMP. The company is conducting clinical trials to evaluate the safety and microbiology of this investigational dental varnish.
C16G2 Varnish is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug remains investigational and has not received regulatory approval. It is not yet available for commercial use.
C16G2 Varnish has been studied in one completed Phase 2 clinical trial with the identifier NCT03004365. The trial evaluated the safety and microbiology of multiple doses of the varnish in dental subjects with dental caries. The study enrolled 33 participants in the United States.
No, C16G2 Varnish is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial. The drug is still in clinical development and has not yet been submitted for regulatory approval.