Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

Matinas BioPharma Nanotechnologies, Inc.270 enrolled

Overview

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Cryptococcal Meningitis

Interventions

MAT2203DRUG

oral lipid nanocrystal amphotericin B

Amphotericin BDRUG

Intravenous Amphotericin B

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CSF cryptococcal antigen (CrAg) positive meningitis * Ability and willingness to provide informed consent * Willing to receive protocol-specified lumbar punctures Exclusion Criteria: * Glasgow Coma Scale \< 15 at time of consent * Received \>= 3 doses of amphotericin B within prior 30 days * Inability to take enteral (oral or nasogastric) medicine * Cannot or unlikely to attend regular clinic visits * Receiving chemotherapy or corticosteroids * Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS) * Pregnancy or breastfeeding * Previous administration of MAT2203 * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments

Outcomes

Primary Outcomes

Survival

All-cause mortality

Time frame: 2 weeks

Secondary Outcomes

Meningitis-free survival

Survival time without Cryptococcus culture-positive relapse of meningitis

Time frame: 10 weeks

Evidence of fungicidal activity

Rate of CSF Cryptococcus clearance (early fungicidal activity \[EFA\])

Time frame: 2 weeks

CSF culture sterility

cumulative incidence of CSF culture sterilization

Time frame: 10 weeks

Central Contacts

Theresa Matkovits, PhD

CONTACT

908-505-0975 tmatkovits@matinasbiopharma.com

Data from ClinicalTrials.gov

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