close

MAT2501

Potentially the first oral formulation of a potent gram-negative antibiotic.

MAT2501 is an orally-administered LNC formulation of the gram-negative antibiotic agent – amikacin. It is designed to provide the safe and targeted delivery of this potent drug.

Amikacin is primarily only available as an IV treatment, which is known to generate high peak levels and heighten the risk of both renal toxicity (affecting kidney function) and ototoxicity (causing permanent hearing loss). MAT2501 can avoid these toxicity levels by delivering the drug directly to the bacterially infected cells.

As a broad-spectrum aminoglycoside, amikacin is highly effective in treating a range of chronic and acute bacterial infections – including Non-Tuberculous Mycobacterium (NTM) infections. We are planning to conduct studies that position MAT2501 as a safer option with the same level of efficacy in treating NTM infections.

A clear difference.

MAT2501 was built with key distinguishing characteristics that can resolve the issues surrounding IV-administered 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.

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.