Phase 2 N=137 Randomized Single-blind Treatment

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

Vulvovaginitis · Yeast Infection · Yeast Infection Vaginal · Candidiasis, Vulvovaginal

Bottom Line

View on ClinicalTrials.gov: NCT02971007 ↗

Enrolled (actual)

137

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Clinical Outcome Assessed at Test of Cure Visit — 13; 12; 24; 12 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral Encochleated Amphotericin B (CAMB) (Drug); Fluconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Matinas BioPharma Nanotechnologies, Inc.
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Outcome Assessed at Test of Cure Visit	13; 12; 24; 12; 8; 7	—
SECONDARY Mycological Outcome Assessed at Test of Cure	9; 7; 27; 16; 13; 4	—
SECONDARY Overall Response	4; 3; 22; 21; 17; 9	—
SECONDARY Change in Composite Clinical Cure Score	-80.9; -80.1; -94.0	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02971007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.