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MAT2203

Phase 1

Cryptococcal Meningitis | Small molecule | Infectious Disease |Matinas Biopharma Holdings, Inc.|Last Updated: Mar 31, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment178

FDA Designations

No designations recorded

Clinical trial landscape

MAT2203 · 1 trial · 1 indication

Phase 1 1
NCT04031833Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)Cryptococcal Meningitis
COMPLETED178 Analytics
PHASE1COMPLETED
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)
Cryptococcal MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Highest dose tolerated without inducing vomiting
7 days

Proportion of cAMB daily dose received and tolerated without vomiting within 30 minutes.

Evidence of fungicidal activity
2 weeks

CSF early fungicidal activity (EFA) during 2-week induction therapy

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a single ascending dose studyEXPERIMENTALPhase IA will consist of a single ascending dose study in 9 participants to test three doses to determine the max tolerated dose.
Phase 1b multiple day dosingEXPERIMENTAL9 subjects will receive the Phase Ia 100% tolerated MAT2203 dose for 7 days.
Phase 2 safety and tolerabilityEXPERIMENTALSafety, tolerability, and microbiologic efficacy of MAT2203 among HIV-infected patients with cryptococcal meningitis compared with standard IV AMB.

Interventions

NameTypeDescription
MAT2203DRUGEncochleated amphotericin B
Amphotericin BDRUGIntravenous amphotericin B
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Phase 1: * Age \>18 years * Calculated creatinine clearance \>70 mL/min/1.73 m2 (measured within 3 months) * Written informed consent Phase 2: * Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG) * Ability and willingness to provide informed consent ...

Countries:Uganda
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Frequently asked questions about MAT2203

What is MAT2203 used for?

MAT2203 is an investigational small molecule being developed for the treatment of cryptococcal meningitis, a serious fungal infection of the brain and spinal cord. It is currently in clinical development and has not been approved by regulatory authorities.

Who makes MAT2203?

MAT2203 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 trials to evaluate the safety and efficacy of this investigational drug.

What phase is MAT2203 in?

MAT2203 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 1 trial has been completed, and the drug remains under investigation for cryptococcal meningitis.

What clinical trials is MAT2203 in?

MAT2203 has been studied in one completed Phase 1 clinical trial, identified as NCT04031833, titled "Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)." This trial enrolled 178 participants in Uganda and evaluated the drug in patients with cryptococcal meningitis.

Is MAT2203 the same as amphotericin?

MAT2203 is an oral formulation of amphotericin, an antifungal medication. The drug is designed to deliver amphotericin in an encochleated form, which may allow for oral administration. It is being studied as a potential treatment for cryptococcal meningitis.