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Encochleated Amphotericin B

Phase 2

Vulvovaginitis | Small molecule | Infectious Disease |Matinas Biopharma Holdings, Inc.|Last Updated: Nov 2, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

Encochleated Amphotericin B · 1 trial · 4 indications

Phase 2 1
NCT02971007Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)Vulvovaginitis
COMPLETED137 Analytics
PHASE2COMPLETED
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
VulvovaginitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Outcome Assessed at Test of Cure Visit
12 days

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)

Secondary Endpoints

Mycological Outcome Assessed at Test of Cure
12 days
Overall Response
12 Days
Change in Composite Clinical Cure Score
Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CAMB 200 mgEXPERIMENTAL200 mg CAMB (MAT2203) Oral Amphotericin B
CAMB 400 mgEXPERIMENTAL400 mg CAMB (MAT2203) Oral Amphotericin B
Fluconazole 150 mgACTIVE_COMPARATORFluconazole Diflucan

Interventions

NameTypeDescription
Oral Encochleated Amphotericin B (CAMB)DRUGlipid-crystal nano-particle formulation amphotericin B
FluconazoleDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites23

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 ...

Countries:United States
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Frequently asked questions about Encochleated Amphotericin B

What is Encochleated Amphotericin B used for?

Encochleated Amphotericin B is an investigational small molecule being developed for the treatment of vulvovaginitis, specifically vulvovaginal candidiasis (VVC), a yeast infection of the vagina. It is an oral formulation of amphotericin B that is being studied as a potential therapy for this condition.

How does Encochleated Amphotericin B work?

Encochleated Amphotericin B is an oral formulation of amphotericin B, an antifungal agent. The encochleated formulation is designed to deliver amphotericin B orally, potentially improving its absorption and tolerability compared to traditional intravenous administration. It targets fungal infections such as vulvovaginal candidiasis.

Who makes Encochleated Amphotericin B?

Encochleated Amphotericin B is being developed by Matinas Biopharma Holdings, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol MTNB. The company is focused on developing lipid-based formulations of drugs to improve their delivery and efficacy.

What phase is Encochleated Amphotericin B in?

Encochleated Amphotericin B is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy in treating vulvovaginal candidiasis.

What clinical trials is Encochleated Amphotericin B in?

Encochleated Amphotericin B has been studied in one completed Phase 2 clinical trial, identified as NCT02971007. This trial evaluated the safety and efficacy of oral encochleated amphotericin B in the treatment of vulvovaginal candidiasis. The trial enrolled 137 female participants in the United States and was actively controlled.

Is Encochleated Amphotericin B the same as CAMB or MAT2203?

Yes, Encochleated Amphotericin B is also known as CAMB and MAT2203. These alternative names refer to the same investigational drug being developed by Matinas Biopharma for the treatment of vulvovaginal candidiasis.