Trial Outcomes & Findings for Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC) (NCT NCT02971007)

Last Updated: 2018-11-02

Results Overview

Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

12 days

Results posted on

2018-11-02

Participant Flow

Recruitment period November 2016 to May 2017 at 22 medical clinics in USA

Enrolled patients were excluded from the study before assignment to groups due to abnormal laboratory test results, negative potassium hydroxide test (KOH) for vaginal yeast or vaginal pH greater than 4.5 during the screening process.

Participant milestones

Participant milestones
Measure	CAMB 200 mg 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg Fluconazole Diflucan Fluconazole
Overall Study STARTED	46	45	46
Overall Study COMPLETED	44	42	45
Overall Study NOT COMPLETED	2	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CAMB 200 mg 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg Fluconazole Diflucan Fluconazole
Overall Study Adverse Event	1	0	0
Overall Study Lost to Follow-up	0	1	1
Overall Study Withdrawal by Subject	0	1	0
Overall Study Patient had yeast at Day 5 visit	1	0	0
Overall Study Patient discontinued study drug	0	1	0

Baseline Characteristics

Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 days

Population: All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline

Outcome measures

Outcome measures
Measure	CAMB 200 mg n=25 Participants 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg n=22 Participants 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg n=32 Participants Fluconazole Diflucan Fluconazole
Clinical Outcome Assessed at Test of Cure Visit Clinical Cure	13 Participants	12 Participants	24 Participants
Clinical Outcome Assessed at Test of Cure Visit Clinical Failure	12 Participants	8 Participants	7 Participants
Clinical Outcome Assessed at Test of Cure Visit Clinical Indeterminate	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 days

Population: All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline

Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)

Outcome measures

Outcome measures
Measure	CAMB 200 mg n=25 Participants 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg n=22 Participants 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg n=32 Participants Fluconazole Diflucan Fluconazole
Mycological Outcome Assessed at Test of Cure Mycological Eradication	9 Participants	7 Participants	27 Participants
Mycological Outcome Assessed at Test of Cure Mycological Persistence	16 Participants	13 Participants	4 Participants
Mycological Outcome Assessed at Test of Cure Mycological Indeterminate	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 Days

Population: All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline

Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).

Outcome measures

Outcome measures
Measure	CAMB 200 mg n=25 Participants 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg n=22 Participants 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg n=32 Participants Fluconazole Diflucan Fluconazole
Overall Response Overall Success	4 Participants	3 Participants	22 Participants
Overall Response Overall Failure	21 Participants	17 Participants	9 Participants
Overall Response Overall Indeterminate	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Between randomization visit (Baseline) and Day 12 visit (Test of Cure)

Population: All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline

The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome. The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.

Outcome measures

Outcome measures
Measure	CAMB 200 mg n=25 Participants 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg n=22 Participants 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg n=32 Participants Fluconazole Diflucan Fluconazole
Change in Composite Clinical Cure Score	-80.9 percent change Standard Deviation 24.63	-80.1 percent change Standard Deviation 44.66	-94.0 percent change Standard Deviation 13.71

Adverse Events

CAMB 200 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CAMB 400 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Fluconazole 150 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CAMB 200 mg n=46 participants at risk 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg n=45 participants at risk 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg n=46 participants at risk Fluconazole Diflucan Fluconazole
Gastrointestinal disorders Diarrhoea	4.3% 2/46 • Number of events 2 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	6.7% 3/45 • Number of events 3 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	0.00% 0/46 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.
Gastrointestinal disorders Nausea	6.5% 3/46 • Number of events 3 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	4.4% 2/45 • Number of events 2 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	2.2% 1/46 • Number of events 1 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.
Infections and infestations Bacterial Vaginosis	6.5% 3/46 • Number of events 3 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	11.1% 5/45 • Number of events 5 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	4.3% 2/46 • Number of events 2 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.
Infections and infestations Urinary Tract Infection	4.3% 2/46 • Number of events 2 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	4.4% 2/45 • Number of events 2 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.	2.2% 1/46 • Number of events 1 • Adverse event data collected from randomization through follow-up phone call between Day 21 to Day 30.

Additional Information

Director Clinical Development

Matinas Biopharma

Phone: 9082953235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential and must consult with the Sponsor before any study data are submitted for publication. Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.
Publication restrictions are in place

Restriction type: OTHER

Measure	CAMB 200 mg n=46 Participants 200 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	CAMB 400 mg n=45 Participants 400 mg CAMB (MAT2203) Oral Amphotericin B Oral Encochleated Amphotericin B (CAMB): lipid-crystal nano-particle formulation amphotericin B	Fluconazole 150 mg n=46 Participants Fluconazole Diflucan Fluconazole	Total n=137 Participants Total of all reporting groups
Age, Continuous	35.7 years STANDARD_DEVIATION 12.63 • n=5 Participants	36.2 years STANDARD_DEVIATION 9.77 • n=7 Participants	34.3 years STANDARD_DEVIATION 11.25 • n=5 Participants	35.4 years STANDARD_DEVIATION 11.24 • n=4 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	45 Participants n=7 Participants	46 Participants n=5 Participants	137 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	31 Participants n=7 Participants	37 Participants n=5 Participants	94 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	79 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (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	46 participants n=5 Participants	45 participants n=7 Participants	46 participants n=5 Participants	137 participants n=4 Participants
Body Mass Index (BMI)	30.49 kg/m2 STANDARD_DEVIATION 8.136 • n=5 Participants	30.64 kg/m2 STANDARD_DEVIATION 8.411 • n=7 Participants	29.50 kg/m2 STANDARD_DEVIATION 6.973 • n=5 Participants	30.21 kg/m2 STANDARD_DEVIATION 7.819 • n=4 Participants