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

Study Overview
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Brief Summary
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This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

Detailed Description
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This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC. Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.

Official Title
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A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)

Conditions
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Vulvovaginitis, Yeast Infection, Yeast Infection Vaginal, Candidiasis, Vulvovaginal

Intervention / Treatment
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* Drug: Oral Encochleated Amphotericin B (CAMB)
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Informed consent Clinical diagnosis of moderate to severe VVC Negative pregnancy test Vaginal pH less than 4.5 Key Exclusion Criteria: Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months Has another cause of vulvovaginitis Has other urogenital infection(s) that would potentially alter their response to disease Has another vaginal or vulvar condition that would confound the interpretation of clinical response Has significant laboratory abnormality at screening Has any known azole-resistant Candida infection; Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMB 200 mg<br>200 mg CAMB (MAT2203) Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|
| Experimental: CAMB 400 mg<br>400 mg CAMB (MAT2203) Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|
| Active Comparator: Fluconazole 150 mg<br>Fluconazole Diflucan | Drug: Fluconazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome Assessed at Test of Cure Visit | 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) | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological Outcome Assessed at Test of Cure | 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) | 12 days | 
| Overall Response | 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). | 12 Days | 
| Change in Composite Clinical Cure Score | 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. | Between randomization visit (Baseline) and Day 12 visit (Test of Cure) |