Matinas BioPharma Initiates EnACT Study of MAT2203 (Oral Amphotericin B) for the Treatment of Fungal Cryptococcal Meningitis
October 14 2019 - 7:00AM
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical
stage biopharmaceutical company, today announced that it has
initiated its Phase 2 EnACT clinical study, which will explore the
use of MAT2203 for both induction and maintenance therapy in
HIV-patients with cryptococcal meningitis, a life-threatening
fungal infection most commonly observed in immunocompromised
individuals.
“We are extremely pleased to advance clinical
development of MAT2203 for the treatment of cryptococcal
meningitis,” commented Theresa Matkovits, Ph.D., Chief Development
Officer of Matinas. “Antifungal resistance poses a major threat to
the lives of vulnerable immunocompromised patients, and MAT2203
could provide an invaluable oral and safe treatment for severe
fungal infections in these patients. EnACT is an important study to
highlight the benefits provided by our lipid nano-crystal (LNC)
drug delivery technology and is a key part of our strategy to
ultimately position MAT2203 as a potential first-line therapy for
the treatment of a variety of invasive fungal infections, including
cryptococcal meningitis. We plan to provide updates on EnACT later
in 2019 and over the course of 2020, as we advance past the maximum
tolerated dose (MTD) portion of this study and advance from
cohort-to-cohort during the efficacy stages.”
EnACT (Encochleated Oral Amphotericin for
Cryptococcal Meningitis Trial) is an open-label, sequential cohort
study, financially sponsored by the National Institutes of Health
(NIH) with David Boulware, M.D., M.P.H, Professor of Medicine at
the University of Minnesota acting as principal investigator for
the study in collaboration with Dr. David Meya, Ph.D. of Makerere
University. This trial utilizes MAT2203, which applies the
Company’s LNC drug delivery technology to orally deliver
amphotericin B, an otherwise IV-only, highly toxic, fungicidal drug
for the treatment of HIV-patients with cryptococcal meningitis.
Oral MAT2203 is designed to target delivery directly to infected
tissues, protecting the body from unnecessary exposure to
amphotericin B, and is expected to be a safer alternative to the
traditional IV-forms of this highly potent drug with a lower
propensity for renal toxicity. The study consists of two distinct
parts; Part 1 is designed to determine the maximum tolerated dose
among people living with HIV but who do not have a fungal
infection. Part 2 is a prospective randomized trial evaluating the
safety, tolerability and efficacy of MAT2203 in HIV-infected
patients with cryptococcal meningitis, compared to treatment with
standard IV-administered amphotericin B as induction therapy.
As previously reported, the Food and Drug
Administration (FDA) has designated MAT2203 as a Qualified
Infectious Disease Product (QIDP) with Fast Track status for four
indications, specifically, the prevention of invasive fungal
infections due to immunosuppressive therapy, and the treatment of
invasive candidiasis, invasive aspergillus and cryptococcal
meningitis. In addition, the FDA granted orphan drug designation to
MAT2203 for the treatment of cryptococossis. Adding orphan drug
designation to the QIDP for the treatment of cryptococcal
meningitis, which is within the scope of this FDA-granted orphan
drug designation, potentially positions MAT2203 for up to 12 years
of marketing exclusivity, if approved.
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.
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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