Matinas BioPharma Receives Orphan Drug Designation From U.S. FDA for MAT2203 for the Treatment of Cryptococcosis
October 07 2019 - 7:00AM
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company, announced today that the
U.S. Food and Drug Administration (FDA) has granted orphan drug
designation to MAT2203, Matinas’ proprietary oral amphotericin B
product, for the treatment of cryptococcosis, a life-threatening
fungal infection most commonly observed in immunocompromised
individuals.
MAT2203 is Matinas’ orally-administered
formulation of the broad-spectrum fungicidal medication
amphotericin B, which is currently in Phase 2 clinical development.
This oral formulation utilizes the Company’s proprietary lipid
nano-crystal (LNC) technology to deliver amphotericin B in a way
that targets infected tissues and avoids the toxicity normally seen
with intravenously administered amphotericin B. This novel
mechanism of delivery has the potential to make MAT2203 an
important and valuable treatment for invasive fungal infections
like cryptococcal meningitis, which is within the scope of this
FDA-granted orphan drug designation.
“Orphan drug designation is yet another major
step forward for MAT2203 in the treatment of life-threatening
fungal infections, and adds to the prior Qualified Infectious
Disease Product (QIDP) and Fast Track designations this product has
already received,” commented Theresa Matkovits, Ph.D., Chief
Development Officer of Matinas. “We believe MAT2203 represents a
promising new approach for the treatment of severe fungal
infections and addresses one of the most important limitations of
current antifungal treatment options. Adding orphan drug
designation to the QIDP for the treatment of cryptococcal
meningitis potentially positions MAT2203 for up to 12 years of
marketing exclusivity, if approved.”
The FDA grants orphan drug designation to novel
drugs or biologics that treat rare diseases or conditions affecting
fewer than 200,000 patients in the U.S. The designation allows the
drug developer to be eligible for a seven-year period of U.S.
marketing exclusivity upon approval of the drug, as well as tax
credits for clinical research costs, the ability to apply for
annual grant funding, clinical trial design assistance, and the
waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
The FDA has previously designated MAT2203 as a
QIDP with Fast Track status for three additional indications,
specifically, the prevention of invasive fungal infections due to
immunosuppressive therapy, the treatment of invasive candidiasis
and invasive aspergillus.
About MAT2203
MAT2203 is an orally-administered formulation of
amphotericin B (a broad spectrum fungicidal agent) applying
Matinas’ proprietary lipid nano-crystal (LNC) delivery technology
platform to create a potentially better tolerated and more
conveniently administered version of this potent drug. Currently,
IV-only administered amphotericin B has shown little to no clinical
resistance and is a major broad-spectrum fungicidal product.
However, IV amphotericin has significant treatment-limiting side
effects, most notably kidney toxicity.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on development of its lead
product candidate, MAT9001, for the treatment of cardiovascular and
metabolic conditions. MAT9001 is a prescription-only omega-3 fatty
acid-based composition, comprised primarily of EPA and DPA, under
development for hypertriglyceridemia, that was specifically
designed to overcome the shortcomings seen from other agents in the
omega-3 class. Company leadership has a deep history and knowledge
of cardiovascular drug development and is supported by a
world-class team of scientific advisors. The company will soon
begin enrolling MAT9001 in a confirmatory head-to-head PD study vs
Vascepa® (icosapent ethyl), after having shown superiority versus
Vascepa in reducing serum triglycerides, Total- and
Non-HDL-Cholesterol, apolipoprotein CIII and PCSK9 levels in a
previous study, with data expected in the fourth quarter of
2020.
In addition, the Company is developing MAT2203,
an oral, encochleated formulation of amphotericin B, to treat
serious invasive fungal infections. The drug is based on Matinas’
proprietary lipid nano-crystal (LNC) platform technology which can
help solve complex challenges relating to the safe and effective
delivery of potent medicines, potentially making them more
targeted, less toxic and orally bioavailable.
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
anticipated capital and liquidity needs, strategic focus and the
future development of its product candidates, including MAT9001 and
MAT2203, the anticipated timing of regulatory submissions, the
anticipated timing of clinical studies, the anticipated timing of
regulatory interactions, 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 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 and Media Contacts
Peter VozzoWestwicke443-213-0505peter.vozzo@westwicke.com
Ian CooneyDirector – Investor Relations &
Corporate DevelopmentMatinas Biopharma, Inc.(415)
722-4563icooney@matinasbiopharma.com
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