MAT2203

Indicated For

Invasive fungal infections, cryptococcal meningitis, aspergillosis

About This Medication

# MAT2203 Compassionate Use Program Patient Guide: How to Get Encochleated Amphotericin B at Low or No Cost MAT2203, also known as encochleated amphotericin B, is an investigational oral formulation of the antifungal drug amphotericin B developed by Matinas BioPharma using their proprietary lipid nanocrystal (LNC) technology. This guide explains the **Compassionate Use Expanded Access Program**, which provides free access to MAT2203 for eligible patients with serious invasive fungal infections when no other treatments work.[1][2] ## About MAT2203 Traditional amphotericin B is given intravenously (IV) and can cause serious side effects like kidney damage, electrolyte imbalances, and infusion reactions, often limiting long-term use. MAT2203 offers an **oral alternative** that early data shows is well-tolerated, with no renal toxicity observed in compassionate use cases, allowing outpatient treatment.[2][3][4] It's being studied for life-threatening infections like cryptococcal meningitis, invasive aspergillosis, mucormycosis, and fusarium infections—especially in patients who can't tolerate IV amphotericin B or azole antifungals due to resistance, interactions, or toxicity.[1][7][8] Currently in Phase 3 trials (e.g., ORALTO trial for aspergillosis), MAT2203 is not FDA-approved but available via this program for patients unable to join clinical trials.[1][8] Over 24 patients have received or completed treatment, with many achieving complete clinical resolution, such as healed wounds or robust responses without IV side effects.[3][4][7] ## Who Qualifies? This program targets patients with **serious or life-threatening invasive fungal infections** where standard options fail. Key criteria include:[1][2][3] - Diagnosis of an invasive fungal infection (e.g., cryptococcal meningitis, aspergillosis, mucor, fusarium). - No suitable alternative treatments: unable to use azoles (due to resistance, intolerance, or drug interactions) or IV amphotericin B (due to toxicity like kidney issues). - Inability to participate in clinical trials. - Physician request on a case-by-case basis. It's ideal for immunocompromised patients (e.g., transplant recipients, cancer patients) at risk of amputation or prolonged hospitalization.[2][6][7] Matinas reviews requests individually; approval isn't guaranteed.[1] ## Income Eligibility As a compassionate use program, there are **no income thresholds**—access is based on medical need, not finances. Medication is provided at **no cost** to qualified patients.[1][2][3] This differs from commercial patient assistance programs tied to Federal Poverty Level (FPL). | Household Size | Income Limit | FPL % | Notes | |---------------|--------------|-------|-------| | Individual | None | N/A | Medical need only[1] | | Couple | None | N/A | Case-by-case review[1] | | Family of 3 | None | N/A | No financial criteria[1] | | Family of 4 | None | N/A | Free for eligible[2] | ## Insurance Requirements **Insurance status does not affect eligibility**—the program serves patients regardless of coverage, including Medicare, Medicaid, or uninsured individuals. It's designed for those with limited options, even if insured, as long as alternatives aren't viable.[1][3][4] No prior authorization from insurance is typically needed, but your doctor coordinates with Matinas.[2] ## Step-by-Step Application Process 1. **Consult Your Doctor**: Discuss MAT2203 with your infectious disease specialist. They must confirm your fungal infection, failed prior therapies, and trial ineligibility.[1] 2. **Physician Submits Request**: Your doctor applies via Matinas BioPharma's Expanded Access Program. Include medical records, culture results, treatment history, and rationale.[1][2] 3. **FDA Review (if needed)**: For single-patient use, FDA may approve quickly; some cases await submission/approval.[3] 4. **Matinas Evaluation**: Reviewed case-by-case; contact Matinas for forms (details below).[1] 5. **Approval and Start**: If approved, initiate under monitoring (e.g., inpatient start at 300mg 4x/day, then outpatient).[2] **Contact Info**: - Website: matinasbiopharma.com (see Expanded Access Policy)[1] - Email/Phone: Reach out via investor relations or medical info on site (specifics case-managed by physicians like in examples).[2] ## Timeline and Delivery - **Approval Time**: Varies; some start soon after request, others await FDA (days to weeks). 4 cases recently pending approval.[3] - **Treatment Duration**: 6+ months in successes; monitored outpatient.[2][7] - **Delivery**: Shipped to doctor's office or hospital; oral capsules for home use post-initiation.[2] ## Alternatives if Denied or No Other Options - **Clinical Trials**: Check clinicaltrials.gov for MAT2203 Phase 2/3 studies (e.g., cryptococcal meningitis, aspergillosis).[1][8] - **Other Antifungals**: IV amphotericin B (short-term), azoles (if tolerable), echinocandins, or combination therapy—though limited in resistant cases.[3] - **Other Expanded Access**: FDA's general compassionate use for other investigational antifungals. - **Financial Aid**: If approved commercially later, manufacturer copay cards; nonprofits like PAN Foundation for antifungals. ## Disclaimer This guide is for informational purposes based on public data as of 2024-2026. MAT2203 is **investigational**—efficacy/safety not fully established. Always consult your healthcare provider. Program details may change; verify with Matinas BioPharma. Not medical advice; individual results vary (e.g., some discontinued due to unrelated issues).[4] Word count: 942.

Program information last verified: March 30, 2026