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

Matinas BioPharma

Status and phase: Completed; Phase 2

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

Treatments: Drug: Oral Encochleated Amphotericin B (CAMB); Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02971007

MB-70005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 137 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 3 patient groups

CAMB 200 mg

Experimental group

Description:

200 mg CAMB (MAT2203) Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 400 mg

Experimental group

Description:

400 mg CAMB (MAT2203) Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)

Fluconazole 150 mg

Active Comparator group

Description:

Fluconazole Diflucan

Treatment:

Drug: Fluconazole