Matinas BioPharma Reports Positive Topline Data from Phase 1 Study of MAT2501
March 27 2017 - 7:35AM
- Oral administration of MAT2501 at all tested
doses yielded blood levels that were well below the labeled safety
limits recommended for IV-administered amikacin -
Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications, today reported positive
topline data from its Phase 1 single-ascending dose study of
MAT2501 in healthy volunteers.
MAT2501 is Matinas BioPharma’s
orally-administered formulation of the broad spectrum IV-only
aminoglycoside antibiotic agent amikacin, which utilizes the
Company’s proprietary lipid-crystal nano-particle cochleate
delivery technology. Amikacin by injection is currently used in
clinical practice to treat different types of chronic and acute
bacterial infections, including non-tuberculous mycobacterium (NTM)
infections and various multidrug-resistant gram negative bacterial
infections. Amikacin by injection generates high blood levels which
are associated with major side effects including nephrotoxicity and
ototoxicity (permanent loss of hearing) and therefore amikacin
blood levels must be monitored closely during use.
This completed Phase 1 study of MAT2501 was a
double-blind, placebo-controlled, single ascending dose study
primarily aimed to evaluate the safety, tolerability, and
pharmacokinetics of MAT2501 in 36 healthy adult subjects. Secondary
aims of the study included an assessment of the effects of food on
tolerability and pharmacokinetics. There were no serious adverse
events reported in the study. Adverse events were mostly mild in
severity and gastrointestinal (GI) in nature, as seen with the
Phase 1 study of MAT2203 (currently in Phase 2). The
incidence of GI adverse events significantly decreased when MAT2501
was administered with food, resulting in improved tolerability.
Oral administration of MAT2501 at all three doses yielded blood
levels of amikacin that were well below the labeled safety
limits recommended for IV-administered amikacin, and
consistent with the results from preclinical studies of
MAT2501.
“We are very pleased with the outcome of our
initial Phase 1 study of MAT2501 and believe that the results of
this study support the further development of MAT2501 for the
treatment of NTM infections as a first indication,” said Roelof
Rongen, Chief Executive Officer. “We have shown that the oral
administration of MAT2501 at doses we expect to use with patients
is well tolerated and yields blood levels well below the labeled
safety limits for amikacin. Our plan is to continue to drive
development of this important product forward in such a way as to
maximize the opportunity we might have in developing and
potentially receiving FDA-approval for what we believe will be the
first orally-available aminoglycoside.”
Upon completion of its Phase 1 program and
meeting with the U.S. Food and Drug Administration (FDA), the
Company plans to initiate a Phase 2 study in patients with NTM lung
disease refractory to guideline therapy. Matinas intends to also
evaluate opportunities or need to conduct human drug-drug
interaction studies and studies in special patient populations,
such as patients with cystic fibrosis or non-lung Mycobacterum
abscessus infections. Based on the limited success and utility
of inhaled therapies in these uses, as well as the oral dosing mode
of our product, Matinas believes that MAT2501 has the potential to
become a highly-differentiated therapy for the treatment of NTM if
approved by FDA.
About MAT2501
MAT2501 is an orally-administered, encochleated
formulation of the broad spectrum IV-only aminoglycoside antibiotic
agent amikacin, which utilizes the Company’s proprietary,
lipid-crystal, nanoparticle delivery technology. Amikacin is
currently used to treat different types of chronic and acute
bacterial infections, including non-tuberculous mycobacterium (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. MAT2501 is specifically designed
to provide targeted delivery of the potent antibiotic amikacin
while providing a significantly improved safety and tolerability
profile. 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. The FDA has designated MAT2501 as a QIDP and an Orphan
Drug for the treatment of NTM infections. The Company also intends
to develop MAT2501 for the treatment of a variety of multi-drug
resistant infections, including gram negative bacterial infections.
If approved, Matinas believes MAT2501 would become the first orally
bioavailable aminoglycoside and represent a significant improvement
over existing therapies in an area of significant unmet medical
need.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage biopharmaceutical company
focused on developing innovative anti-infectives for orphan
indications. The Company's proprietary, disruptive technology
utilizes lipid-crystal nano-particle cochleates to nano-encapsulate
existing drugs, making them safer, more tolerable, less toxic and
orally bioavailable. The Company's lead drug candidate MAT2203,
currently in Phase 2, is an orally-administered, encochleated
formulation of amphotericin B (a broad spectrum fungicidal agent).
MAT2501, the Company’s orally-administered encochleated formulation
of amikacin (a broad spectrum aminoglycoside antibiotic agent) for
acute bacterial infections, including non-tuberculous mycobacterium
(NTM) and multi-drug resistant gram-negative bacterial infections,
reported positive topline data from the Phase 1 single-ascending
dose study in healthy volunteers. Matinas is advancing its MAT2501
Phase 1 program in preparation of a Phase 2 study in patients.
The Company's lead anti-infective product candidates, MAT2203
and MAT2501, position Matinas BioPharma to become a leader in the
safe and effective delivery of anti-infective therapies utilizing
its proprietary lipid-crystal nano-particle cochleate formulation
technology. For more information, please visit
www.matinasbiopharma.com and connect with the Company on Twitter,
LinkedIn, Facebook, and Google+.
Forward Looking Statements:
This release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including those relating to the Company's strategic focus and the
future development of its product candidates, including MAT2203 and
MAT2501, the anticipated timing of regulatory submissions, the
anticipated timing of clinical studies, the Company’s ability to
identify and pursue development and partnership opportunities for
its products or platform delivery technology on favorable terms, if
at all, and the ability to obtain required regulatory approval and
other statements that are predictive in nature, that depend upon or
refer to future events or conditions. All statements other than
statements of historical fact are statements that could be
forward-looking statements. Forward-looking statements include
words such as "expects," "anticipates," "intends," "plans,"
"could," "believes," "estimates" and similar expressions. These
statements involve known and unknown risks, uncertainties and other
factors which may cause actual results to be materially different
from any future results expressed or implied by the forward-looking
statements. Forward-looking statements are subject to a number of
risks and uncertainties, including, but not limited to, our ability
to obtain additional capital to meet our liquidity needs on
acceptable terms, or at all, including the additional capital which
will be necessary to complete the clinical trials of our product
candidates; our ability to successfully complete research and
further development and commercialization of our product
candidates; the uncertainties inherent in clinical testing; the
timing, cost and uncertainty of obtaining regulatory approvals; our
ability to maintain and derive benefit from the Qualified
Infectious Disease Product (QIDP), Orphan and/or Fast Track
designations for MAT2203 and MAT2501, which does not change the
standards for regulatory approval or guarantee regulatory approval
on an expedited basis, or at all; our ability to protect the
Company's intellectual property; the loss of any executive officers
or key personnel or consultants; competition; changes in the
regulatory landscape or the imposition of regulations that affect
the Company's products; and the other factors listed under "Risk
Factors" in our filings with the SEC, including Forms 10-K, 10-Q
and 8-K. Investors are cautioned not to place undue reliance on
such forward-looking statements, which speak only as of the date of
this release. Except as may be required by law, the Company does
not undertake any obligation to release publicly any revisions to
such forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events. Matinas BioPharma's product candidates are all in a
development stage and are not available for sale or use.
Investor Contact
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: jenene@jenenethomascommunications.com