Matinas BioPharma Announces Positive Opinion by the European Medicines Agency on Orphan Drug Designation for MAT2203 for the Treatment of Cryptococcosis
July 25 2022 - 6:30AM
Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage
biopharmaceutical company focused on improving the
intracellular delivery of nucleic acids and small molecules with
its lipid nanocrystal (LNC) platform technology, today announced
that the European Medicines Agency (EMA) Committee for Orphan
Medicinal Products (COMP) has adopted a positive opinion
recommending MAT2203 for designation as an orphan medicinal product
for the treatment of cryptococcosis. The U.S. Food and Drug
Administration (FDA) previously granted Orphan, Qualified
Infectious Disease Product (QIDP) and Fast Track Designations to
MAT2203 for the treatment of cryptococcosis. Matinas is currently
preparing to evaluate MAT2203 in a pivotal Phase 3 trial in
patients with cryptococcal meningitis.
“The positive opinion for Orphan Drug
Designation from the EMA is another important milestone for MAT2203
and reflects our commitment to position MAT2203 for global
development and approval,” said Theresa Matkovits, Ph.D., Chief
Development Officer of Matinas BioPharma. “We believe that MAT2203
has the potential to transform the treatment of cryptococcosis, as
well as other deadly invasive fungal infections. This designation
reflects the significant need for new therapies to treat fungal
disease and we look forward to working with the EMA and FDA to
potentially deliver MAT2203 to patients.”
The orphan medicinal product designation by the
European Commission is granted to medicines that treat, prevent, or
diagnose a life-threatening or chronically debilitating rare
disease, with a prevalence in the EU of not more than five in
10,000 people, and with either no currently approved method of
diagnosis, prevention, or treatment or with significant benefit to
those affected by the disease. The designation potentially provides
certain benefits to Matinas, including 10-year EU market
exclusivity upon regulatory approval, if received, reductions in
EMA application fees, and access to protocol assistance.
The FDA has previously designated MAT2203 as a
QIDP with Fast Track Status and Orphan Drug Disease designation for
three additional indications: the treatment of invasive
candidiasis, and treatment of invasive aspergillosis, and the
prevention of invasive fungal infections due to immunosuppressive
therapy.
About MAT2203
MAT2203 is Matinas’ orally administered
formulation of the broad-spectrum fungicidal medication
amphotericin B, which is currently completing Phase 2 clinical
development. This oral formulation utilizes the Company’s
proprietary 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
oral delivery has the potential to make MAT2203 an important and
invaluable treatment for invasive fungal infections like
cryptococcal meningitis, mucormycosis, and invasive
aspergillosis.
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company
focused on improving the intracellular delivery of nucleic acids
and small molecules with its lipid nanocrystal (LNC) platform
technology. The Company is developing its own internal portfolio of
products as well as partnering with leading pharmaceutical
companies to develop novel formulations that capitalize on the
unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
challenges in achieving safe and effective intracellular delivery,
for both small molecules and larger, more complex molecules, such
as mRNA, DNA plasmids, antisense oligonucleotides, and vaccines.
The combination of a unique mechanism of action and flexibility
with formulation and route of administration (including oral),
positions Matinas’ LNC technology to potentially become the
preferred next-generation intracellular drug delivery vehicle with
distinct advantages over both lipid nanoparticles and viral
vectors.
The Company is focused on developing an internal
and external pipeline of drugs candidates based on the LNC
platform. Internally, the Company has two clinical stage
assets. MAT2203 is an oral, LNC formulation of the highly
potent antifungal medicine amphotericin B, currently in Phase 2
clinical trials; MAT2501 is an oral, LNC formulation of the
broad-spectrum aminoglycoside, amikacin, primarily used to treat
chronic and acute bacterial infections, and currently in Phase
1. Externally, the Company has established a broad set of
relationships with multiple global pharmaceutical collaborators,
including BioNTech (mRNA), the National Institutes of Health and
Gilead Sciences (antivirals), and Genentech, a member of the
Roche Group (small molecules, antisense oligonucleotides, and
antibody fragments).
For more information, please visit
www.matinasbiopharma.com.
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 our business
activities, our strategy and plans, our collaboration with
BioNTech, the potential of our LNC platform delivery technology,
and the future development of its product candidates, the Company’s
ability to identify and pursue development, licensing 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 Contact
Peter VozzoICR
Westwicke443-213-0505peter.vozzo@westwicke.com
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