Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects (NCT NCT03196219)

Results Overview

To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Evaluated over up to 2 months

Results posted on

2022-12-22

Participant Flow

Enrollment into Study Arms 1 and 2 was concurrent and based on enrollment logistics. Study Arm 3 was to be initiated after a microbiology data review of 2-week follow-up data from Study Arm 2. Study Arm 3 was not initiated.

Participant milestones

Participant milestones
Measure	Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. C16G2: C16G2	Arm 2A: Single-Blind C16G2 Varnish Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo).	Arm 2B: Single-Blind Placebo Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo).
Overall Study STARTED	8	6	6
Overall Study COMPLETED	8	6	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish n=8 Participants Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. C16G2: C16G2	Arm 2A: Single-Blind C16G2 Varnish n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo	Arm 2B: Single-Blind Placebo n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo	Total n=20 Participants Total of all reporting groups
Age, Continuous	18.8 years n=5 Participants	24.1 years n=7 Participants	24.1 years n=5 Participants	22 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	20 participants n=4 Participants
S. mutans of 1.0 x 105 CFUs/mL or greater	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants

PRIMARY outcome

Timeframe: Evaluated over up to 2 months

Population: Enrollment into Study Arms 1 and 2 was concurrent and based on enrollment logistics. Study Arm 3 was to be initiated after a microbiology data review of 2-week follow-up data from Study Arm 2. Study Arm 3 was not initiated.

To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.

Outcome measures

Outcome measures
Measure	Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish n=8 Participants Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. C16G2: C16G2	Arm 2A: Single-Blind C16G2 Varnish n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo	Arm 2B: Single-Blind Placebo n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo
Antimicrobial Activity of C16G2 Saliva Sample: S. mutans Change from Baseline	-0.49 CFU/mL Standard Deviation 0.48	0.23 CFU/mL Standard Deviation 0.56	-0.44 CFU/mL Standard Deviation 0.51
Antimicrobial Activity of C16G2 Dental Plaque Sample: S. mutans Change from Baseline	-0.31 CFU/mL Standard Deviation 0.38	-0.22 CFU/mL Standard Deviation 0.95	-0.31 CFU/mL Standard Deviation 0.73

PRIMARY outcome

Timeframe: 1 day post last study drug administration

Population: Enrollment into Study Arms 1 and 2 was concurrent and based on enrollment logistics. Study Arm 3 was to be initiated after a microbiology data review of 2-week follow-up data from Study Arm 2. Study Arm 3 was not initiated.

To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2.

Outcome measures

Outcome measures
Measure	Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish n=8 Participants Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. C16G2: C16G2	Arm 2A: Single-Blind C16G2 Varnish n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo	Arm 2B: Single-Blind Placebo n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo
Total Oral Bacterial Levels Dental Plaque Sample - Total Bacteria by TH Agar Plating from Baseline	-0.214 CFU/mL Standard Deviation 0.312	-0.21 CFU/mL Standard Deviation 0.63	-0.18 CFU/mL Standard Deviation 0.42
Total Oral Bacterial Levels Saliva Sample - Total Bacteria by TH Agar Plating from Baseline	0.001 CFU/mL Standard Deviation 0.24	0.075 CFU/mL Standard Deviation 0.28	-0.155 CFU/mL Standard Deviation 0.130

SECONDARY outcome

Timeframe: Up to 7 days post last study drug administration

Population: Enrollment into Study Arms 1 and 2 was concurrent and based on enrollment logistics. Study Arm 3 was to be initiated after a microbiology data review of 2-week follow-up data from Study Arm 2. Study Arm 3 was not initiated.

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.

Outcome measures

Outcome measures
Measure	Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish n=8 Participants Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. C16G2: C16G2	Arm 2A: Single-Blind C16G2 Varnish n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo	Arm 2B: Single-Blind Placebo n=6 Participants Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). C16G2: C16G2 Placebo: Varnish Placebo
To Evaluate the Safety of Multiple C16G2 Participants with Adverse Events Related to Study Drug	0 Participants	0 Participants	0 Participants
To Evaluate the Safety of Multiple C16G2 Participants with Clinical Significant Oral Cavity Changes	0 Participants	0 Participants	0 Participants
To Evaluate the Safety of Multiple C16G2 Participants with Clinical Significant Vital Sign Changes	0 Participants	0 Participants	0 Participants
To Evaluate the Safety of Multiple C16G2 Participants with Abnormal Physical Exam Findings	0 Participants	0 Participants	0 Participants

Adverse Events

Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2A: Single-Blind C16G2 Varnish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2B: Single-Blind Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Operations

Armata Pharmaceuticals, Inc.

Phone: 3106652928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place