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Amphotericin B

Phase 2

Candidiasis, Chronic Mucocutaneous | Small molecule | Infectious Disease |Matinas Biopharma Holdings, Inc.|Last Updated: Aug 7, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

Amphotericin B · 1 trial · 1 indication

Phase 2 1
NCT02629419CAMB/MAT2203 in Patients With Mucocutaneous CandidiasisCandidiasis, Chronic Mucocutaneous
COMPLETED4 Analytics
PHASE2COMPLETED
CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis
Candidiasis, Chronic MucocutaneousUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Response to Treatment of Mucocutaneous Candidiasis
14-days at highest titrated dose

Number of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.

Secondary Endpoints

Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Postdose
Single and Multiple Doses (14-days)
Maximum Plasma Concentration (Cmax)
Single and Multiple Doses (14-days)
Time to Reach Maximum Plasma Concentration (Tmax)
Single and Multiple Doses (14-days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CAMB (Encochleated Amphotericin B)EXPERIMENTALEncochleated Amphotericin B (200 mg, 400 mg, 800 mg)

Interventions

NameTypeDescription
Amphotericin BDRUGOral lipid nanocrystal formulation of amphotericin B
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have a clinical diagnosis of at least one of the following: * Persistent oropharyngeal candidiasis (OPC) for greater than or equal to 5 days documented on at least one occasion by potassium hydroxide (KOH) test or fungal stain and confirmed by mycological culture...

Countries:United States
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Frequently asked questions about Amphotericin B

What is Amphotericin B used for in Chronic Mucocutaneous Candidiasis?

Amphotericin B is being studied for the treatment of Chronic Mucocutaneous Candidiasis, a persistent fungal infection. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated for its ability to address this condition, though it is not yet approved for this use.

Who makes Amphotericin B?

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 conducting clinical research on this drug for the treatment of Chronic Mucocutaneous Candidiasis.

What phase is Amphotericin B in?

Amphotericin B is in Phase 2 clinical development for Chronic Mucocutaneous Candidiasis. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 study has been completed, and the drug remains under evaluation for this indication.

What clinical trials is Amphotericin B in?

Amphotericin B has one completed Phase 2 clinical trial registered as NCT02629419, titled "CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis." The study enrolled 4 participants in the United States and was an uncontrolled, non-randomized trial. No active trials are currently listed for this drug.

Is Amphotericin B the same as MAT2203?

Amphotericin B is also known as MAT2203, as indicated by the clinical trial title. The Phase 2 study NCT02629419 refers to the drug as CAMB/MAT2203, confirming that MAT2203 is an alternative name for Amphotericin B in this development program.