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MAT2501

MAT2501

Potentially safe and well-tolerated at every dose level, as an aminoglycoside with targeted delivery.

Existing Therapies

Associated with major side effects, including hearing loss and kidney damage due to high levels of toxicity.

MAT2501

Renders amikacin the only aminoglycoside available through oral administration.

Existing Therapies

Currently only available to patients in IV-administered formulations, with the exception of one approved drug for inhaling amikacin.

MAT2501

Potentially safe and well-tolerated at every dose level, as an aminoglycoside with targeted delivery.

Existing Therapies

Associated with major side effects, including hearing loss and kidney damage due to high levels of toxicity.

MAT2501

Renders amikacin the only aminoglycoside available through oral administration.

Existing Therapies

Currently only available to patients in IV-administered formulations, with the exception of one approved drug for inhaling amikacin.

FDA designated MAT2501 as a QIDP and Orphan Drug for the treatment of NTM infections

The path to clinical success.

Supported by funding from the Cystic Fibrosis Foundation, we have been able to conduct preclinical animal studies as proof of concept for the potential efficacy of orally administered MAT2501.

Pipeline

Completed Studies

Safety and PK Assessment of Oral Encochleated Amikacin

PHASE 1

OBJECTIVE

A double-bind, placebo-controlled, single-ascending dose study to evaluate the safety, tolerability and pharmacokinetics of MAT2501 following oral administration in healthy adult subjects.

OVERVIEW

Inclusion Criteria: Healthy adults.

Trial Design: Subjects were given a single-ascending (200mg, 400mg, 800mg) oral dose of MAT2501. The drug kinetics, tolerability and safety were evaluated throughout.

RESULTS

At all tested doses, MAT2501 yielded blood levels that were well below the safety levels recommended for injected amikacin. Overall, the drug was well-tolerated with no serious adverse events reported. Any side effects were mild, gastro-intestinal and not believed to be of antibiotic nature.

Development Plan

Product Optimization:
We intend to initiate further development of MAT2501 as a treatment for Non-Tuberculous Mycobacterial (NTM) infections. We are also exploring the formulation of MAT2501 as a treatment for multi-drug resistant gram negative bacterial infections pending financial support from the Cystic Fibrosis Foundation.