Matinas starts dosing in phase 1 study of orally administered aminoglycoside antibiotic MAT2501

Data from this study is expected to be announced in the first half of 2017. 

MAT2501 is Matinas BioPharma’s orally-administered, encochleated formulation of the broad spectrum IV-only aminoglycoside antibiotic agent amikacin, which utilizes the Company’s proprietary lipid-crystal nano-particle delivery technology.

Amikacin is currently used to treat different types of chronic and acute bacterial infections, including NTM infections and various multidrug-resistant gram negative bacterial infections. IV-administered amikacin is associated with major side effects including nephrotoxicity and ototoxicity (permanent loss of hearing) with long-term use.

Matinas BioPharma CEO Roelof Rongen said: “We are thrilled to have started the dosing of subjects in this Phase 1 study of MAT2501, the third dosing commencement in a human study by the Company over the last three months. We have made great strides on the clinical development front this year across our entire pipeline. 

"The start of this study represents an important step forward in advancing our proprietary cochleate formulation of amikacin into human clinical trials, which we believe could be a game-changing orally available aminoglycoside antibiotic treatment.

“We now have two product candidates in the clinic and expect the first half of 2017 to be an exciting time for our Company and its stockholders.  We anticipate important clinical data from this Phase 1 study of MAT2501, as well as our ongoing Phase 2 studies with MAT2203, our orally delivered formulation of the antifungal amphotericin B,” added Mr. Rongen.

This Phase 1 study is a double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of MAT2501 in healthy adult subjects.

The primary objectives of the study are to assess the pharmacokinetic (PK) profile of amikacin following single ascending oral doses of MAT2501 as well as safety and tolerability. Secondary objectives include the assessment of the effect of food on the PK of amikacin following a single oral dose of MAT2501.

MAT2501 is specifically designed to provide targeted delivery of the potent antibiotic amikacin while providing a significantly improved safety and tolerability profile, in order to allow for chronic dosing of this potent antibiotic agent. In preclinical studies MAT2501 demonstrated oral bioavailability and targeted delivery of amikacin directly to the site of infection in both pulmonary (lung) and disseminated NTM infections. 

FDA guidance for the treatment of patients with of NTM infections refractory to guideline therapy includes a treatment duration in the range of 12 to 18 months.  The profile of MAT2501 was designed to allow for safe and tolerable use of amikacin during such long-term treatment.

The U.S. Food and Drug Administration (FDA) has already designated MAT2501 as a Qualified Infectious Disease Product (QIDP) and as an Orphan Drug for the treatment of NTM. Orphan Drug designation of MAT2501 provides for a seven-year marketing exclusivity period against competition in the United States upon FDA approval, as well as other incentives and exemptions, including waiver of Prescription Drug User Fee Act (PDUFA) filing fees and tax credits for the cost of the clinical research.

If MAT2501 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, provides for a potential total of 12 years of marketing exclusivity.

The Company also intends to explore the development of MAT2501 for the treatment of a variety of multi-drug resistant, gram negative bacterial infections.