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

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.

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