Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3 (EnACT3)

Matinas BioPharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Cryptococcal Meningitis

Treatments: Drug: Amphotericin B; Drug: MAT2203

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05541107

CTA 0217 (Other Identifier)

MB-70018

Details and patient eligibility

About

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

Full description

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

MAT2203 Induction / MAT2203 Consolidation

Experimental group

Description:

2 days IV Amphotericin B (AMB) + flucytosine (5FC) followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by MAT2203 +fluconazole for 4 weeks of consolidation therapy

Treatment:

Drug: MAT2203

MAT2203 Induction / SOC Consolidation

Experimental group

Description:

2 days IV AMB + 5FC followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by 4 weeks of standard of care consolidation therapy

Treatment:

Drug: MAT2203

SOC Induction / SOC Consolidation

Active Comparator group

Description:

Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole)

Treatment:

Drug: Amphotericin B