MAT2203

Enabling a safe delivery of the top antifungal treatment.

Leveraging our LNC technology, we have developed MAT2203 – an oral and non-toxic encochleated form of amphotericin B (CAmB). This antifungal drug is the primary broad-spectrum treatment for immunocompromised patients. Unlike some other therapies, it doesn’t simply stop fungus from growing, but kills it entirely. Until now, amphotericin B has only been available through intravenous administration, which can lead to kidney or “renal” toxicity.

Combining the same level of fungicidal efficacy with targeted delivery and a lower risk of toxicity, MAT2203 has the potential to be a game changer. It delivers CAmB directly to the infected tissues, shielding the body from unnecessary exposure to the drug. Patients who take it could also benefit from shorter hospital stays, lower costs and easier access to amphotericin B.


FDA-granted Fast Track, Qualified Infectious Disease Product (QIDP) & Orphan Drug designations:
  • Treatment of invasive candidiasis and aspergillosis
  • Prevention of IFIs in patients on immunosuppressive therapy
  • Treatment of cryptococcosis, commonly seen in HIV and other immunocompromised patients

A clear difference.

As a highly differentiated formulation of such an effective fungicide, MAT2203 can transform the way physicians approach fungal infections.

MAT2203

By delivering amphotericin B to the site of active infection, it has a low risk of drug interactions and toxicity of the kidneys, liver, skin or central nervous system.  

Existing Therapies

Often have significant side effects, most notably kidney damage, as they leave highly toxic concentrations of amphotericin B in the blood and tissues.

MAT2203

Potentially the first oral formulation of amphotericin B as well as the only broad spectrum fungicidal agent available.

Existing Therapies

Exclusively administer IV-form amphotericin B, a method with high risk of toxicity.

MAT2203

By delivering amphotericin B to the site of active infection, it has a low risk of drug interactions and toxicity of the kidneys, liver, skin or central nervous system.  

Existing Therapies

Often have significant side effects, most notably kidney damage, as they leave highly toxic concentrations of amphotericin B in the blood and tissues.

MAT2203

Potentially the first oral formulation of amphotericin B as well as the only broad spectrum fungicidal agent available.

Existing Therapies

Exclusively administer IV-form amphotericin B, a method with high risk of toxicity.

We are receiving financial support from National Institutes of Health (NIH) through key efficacy data.

The path to clinical success.

As we continue to develop and optimize MAT2203, we are receiving increasingly more promising clinical results concerning the safety, tolerability and efficacy of this product.

Pipeline

Completed Studies

Single Ascending Dose (SAD) Study

PHASE 1

OBJECTIVE

A single-ascending dose, double-bind, placebo controlled study to determine the pharmacokinetics, safety and tolerability of MAT2203.

OVERVIEW

Study Population: 48 subjects

Inclusion Criteria: Healthy adult volunteers.

Trial Design: Volunteers were administered single-ascending doses of MAT2203 (200 mg, 400 mg, 800 mg) and placebo-controlled at each dose.

RESULTS

MAT2203 appeared to be safe at all doses. There were no serious adverse events or renal toxicity observed. Any incidence of GI events was dose dependent. Cmax and AUC were relatively flat with increasing doses.

Encochleated Oral Amphotericin for Refractory Mucocutaneous Candidiasis

PHASE 2A

OBJECTIVE

An ongoing open-label, dose-titration trial to determine the efficacy, safety, and pharmacokinetics of MAT2203 for treating mucocutaneous candidiasis infections; conducted in partnership with the National Institutes of Health (NIH).

OVERVIEW

Study Population: Up to 16 patients

Inclusion Criteria: Patients aged 18 to 75 years with mucocutaneous candidiasis (esophageal, oropharyngeal, or vulvovaginal) who are refractory or intolerant to standard non-intravenous therapies.

Trial Design: Initially, patients were treated in a short-term dose titration period, where the dose was increased in patients that did not respond clinically over 14 days. Patients who did not respond clinically to the highest dose of drug discontinued the protocol. Those that responded to treatment and tolerated the study medication became eligible for administration of MAT2203 for the course of 8 months, and then again for 6 months.

RESULTS

All enrolled patients met their primary efficacy endpoint, achieving ≥ 50% improvement in clinical signs and symptoms. MAT2203 was well tolerated at 400mg and 800mg for prolonged periods, and in some patients for more than three years. Kidney and liver function parameters remained well within the normal ranges during the core study, as well as during the first 6-month extension of this study. There was no observed renal or hepatic toxicity. The majority of adverse events observed were mild in severity and mostly unrelated to the drug. This study is ongoing but closed to new enrollment as the primary endpoint was achieved.

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Ongoing Studies

Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)

PHASE 1A

OBJECTIVE

An NIH-funded, open-label, sequential cohort, single-ascending dose study designed to determine the maximum tolerated dose among people living with HIV, but who do not have a fungal infection.

OVERVIEW

Study Population: 27 patients

Inclusion Criteria: HIV-infected patients with no active neuro-infections (meningitis or other acute illnesses).

Trial Design: Patients were administered MAT2203 (1-2g) in 4 to 6 divided doses for up to 24 hours under observation. High calcium drinks and meals were provided at scheduled times. Throughout the study, blood was drawn to record pharmacokinetics and assess safety.

PHASE 1B

OBJECTIVE

An NIH-funded, open-label, sequential cohort, multi-day study designed to determine the maximum tolerated dose among people living with HIV, but who do not have a fungal infection.

OVERVIEW

Study Population: 9 patients

Inclusion Criteria: HIV-infected patients with no active neuro-infections (meningitis or other acute illnesses).

Trial Design: Patients were administered the highest 100% tolerated dose from Phase 1a of MAT2203 in 4 to 6 divided doses for 7 days under observation. High calcium drinks and meals were provided at scheduled times. Throughout the study, blood was drawn to record pharmacokinetics and ensure safety.

PHASE 2

OBJECTIVE

An NIH-funded, prospective randomized trial evaluating the safety, tolerability and efficacy of MAT2203 in HIV-infected patients with cryptococcal meningitis, compared to treatment with standard IV-administered amphotericin B as induction therapy. It will ultimately assess the potential for all-oral induction and maintenance therapy with MAT2203.

OVERVIEW

Study Population: 140 patients

Inclusion Criteria: HIV-infected patients with cryptococcal meningitis.

Trial Design: 100 patients will receive MAT2203 and flucytosine (5-FC) in 4 stages, with escalating durations of MAT2203 and decreasing durations of IV amphotericin B. In cohorts 2 and 4, 40 control patients will receive the standard of care – IV-administered amphotericin B and 5-FC. Patients will receive induction treatment for 14 days, followed by consolidation therapy for up to 10 weeks. An independent Data Monitoring Committee assured safety and efficacy throughout the trial.

Phase 2

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