–100% (three out of three) of patients have now
met the primary endpoint in achieving ≥ 50% clinical response with
MAT2203 –
Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a
clinical-stage biopharmaceutical company focused on developing
innovative anti-infectives for orphan indications, today announced
that investigators from the National Institutes of Health (“NIH”)
have relayed to the Company positive data from a third patient
enrolled in the collaborative Phase 2a clinical study of Matinas’
lead anti-infective product candidate MAT2203 for the treatment of
chronic refractory mucocutaneous candidiasis (“CMC”) infection.
This third patient, with long-standing azole resistant
mucocutaneous candidiasis, met the primary endpoint of the Phase 2a
study in achieving ≥ 50% clinical response with treatment of
MAT2203. MAT2203 was well tolerated with any adverse events
observed being mild in severity and unrelated to study drug.
With this third positive response, the study has met its
statistical hurdle for success.
MAT2203 is the Company’s orally-administered,
encochleated formulation of the broad spectrum fungicidal
medication amphotericin B. Matinas BioPharma’s proprietary
lipid-crystal nano-particle formulation of amphotericin B has a
novel mechanism of absorption and distribution to infected tissues
and has the potential to transform the way this potent fungicidal
agent is administered and used in clinical practice.
“With the statistical success hurdle that was
prospectively set at a 20% patient-response probability and now
seeing a clinical response in three out of three patients, we have
successfully achieved the 3 out of 16 possible clinical responders
required for the study to meet its primary endpoint. This is
a major milestone for this study and our platform technology more
broadly,” said Roelof Rongen, Chief Executive Officer. “We continue
to develop invaluable data in patients receiving MAT2203 and are
exploring options with our valued collaborators at the NIH to
determine next best steps for this study. In addition to
impressive efficacy results in this difficult-to-treat patient
population, we remain very excited about the long-term safety data
of MAT2203. Whereas today amphotericin B can only be used in
limited, acute settings due to its significant toxicity, we now
have multiple patients who have been taking MAT2203 for almost a
full year with no signs of kidney or liver toxicity.”
The third patient in this study was diagnosed
with a dual Candida albicans and C. glabrata infection with azole
resistance. The predominant manifestation was esophageal
candidiasis, which had been refractory to treatment for a prolonged
period. Patient 03 achieved a reduction in clinical symptoms
at an efficacious orally administered dosage of 800 mg MAT2203 per
day, meeting the response criterium of ≥ 50% reduction in clinical
symptoms. MAT2203 was generally well tolerated by Patient 03
and there were no signs of nephrotoxicity, hypokalemia or
hepatoxicity (measured by ALT and AST). Indicators of kidney and
liver toxicity remained within normal limits throughout the
treatment period. For this patient, no underlying
immunocompromising condition was diagnosed. Patients 01 and
02, both with an underlying hereditary immunodeficiency called
Job’s Syndrome, also known as Autosomal Dominant Hyper IgE Syndrome
(AD-HIES), enrolled earlier in this trial and achieved reduction in
clinical symptoms of 57% (at 800mg/day) and 85% (at
400mg/day). The first two patients have enrolled in a
long-term study extension and have shown no signs of kidney or
liver toxicity over the approximately twelve months of being
administered MAT2203. Furthermore, the clinical response to
MAT2203 seen in these patients has been maintained and/or improved
during the extension period in addition to patients reporting
meaningful quality-of-life improvements.
“We remain extremely grateful to the patients
for their ongoing participation and to the NIH for conducting this
study,” commented Raphael J. Mannino, Ph.D., Matinas BioPharma’s
Chief Scientific Officer. “As we look forward to our upcoming
meeting with the FDA, we are positioning MAT2203 to be used by and
for patients who today have very few treatment or prevention
options, either due to increasing drug resistance, toxicity or
use-limiting drug to drug interaction with other therapies.”
The Phase 2a study is being conducted at the
National Institutes of Health Clinical Center in Bethesda, MD,
under the direction of Dr. Alexandra Freeman. The ongoing
open-label, dose-titration study is designed to assess the
efficacy, safety, tolerability and pharmacokinetics of MAT2203 in
predominantly hereditary immunodeficient patients with a recurrent
or chronic mucocutaneous candidiasis infection (esophageal,
oropharyngeal, vaginal) who are refractory or intolerant to
standard non-intravenous therapies. The study may enroll up to 16
patients, and study endpoint in the statistical analysis plan is
defined as a response in three or more patients. The study includes
14-day dosing and evaluation periods. Depending on clinical
response during each treatment period, investigators will have the
ability to continue the effective dose for 28 total days or
increase the dose of MAT2203 up to two times and extend treatment
to a maximum of 54 days. To date, the Institutional Review Board of
the NIAID, NIH has granted approval for two separate 6-month
open-label safety extensions of this Phase 2a study to allow
patients to continue to receive MAT2203.
About Mucocutaneous Candidiasis
Mucocutaneous candidiasis is a group of
syndromes resulting in infections of the skin, nails and mucous
membranes. These infections are caused by opportunistic candida
yeast, the most common cause of fungal infections worldwide. There
are more than 20 species of candida that can cause infection in
humans, the most common of which is candida albicans. A variety of
disorders including endocrine dysfunctions, hereditary
immune-system disorders, alopecia, vitiligo, malabsorption
syndromes, neoplasms and other infections may also occur in
patients with chronic reoccurring mucocutaneous candidiasis and
autoimmune disorders. Current anti-fungal treatment management
options are limited, and relapse is common following
discontinuation of certain therapies. In addition, the increasing
resistance of certain strains to standard antifungal treatments is
a growing concern.
About MAT2203
MAT2203 is an orally-administered, encochleated
formulation of amphotericin B (a broad spectrum fungicidal agent).
Little to no clinical resistance has been reported to date with
amphotericin B as compared to the rapidly emerging drug resistance
seen in other antifungal therapies. Currently, IV-only administered
amphotericin B is the only broad spectrum fungicidal available but
its IV-delivery results in significant treatment-limiting side
effects, including nephrotoxicity. The ability to provide
amphotericin B orally using our proprietary and novel oral
formulation may offer a new and promising alternative for patients
and doctors. The FDA has designated MAT2203 as a Qualified
Infectious Disease Product (QIDP) for the treatment of invasive
candidiasis and the treatment of aspergillosis, as well as for the
prevention of invasive fungal infections due to immunosuppressive
therapy. MAT2203 is also being explored for treatment of additional
anti-fungal indications and may have the potential for Orphan Drug
Designation in certain of these indications.
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 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,
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 maintain and derive
benefit from the Qualified Infectious Disease Product (QIDP),
Orphan and/or Fast Track designations for MAT2203, 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 ContactJenene ThomasJenene Thomas
Communications, LLCPhone: +1 (908) 938-1475Email:
jenene@jenenethomascommunications.com
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