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

Matinas BioPharma Nanotechnologies, Inc.137 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

137

Conditions

Vulvovaginitis Yeast Infection Yeast Infection Vaginal Candidiasis, Vulvovaginal

Interventions

Oral Encochleated Amphotericin B (CAMB)DRUG

lipid-crystal nano-particle formulation amphotericin B

FluconazoleDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (23)

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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)

Time frame: 12 days

Secondary Outcomes

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)

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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