Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications, today reported topline data
from its Phase 2 safety, tolerability and efficacy study
of MAT2203 in women with moderate to severe vulvovaginal
candidiasis (VVC). The Phase 2 study achieved its primary
endpoint in demonstrating MAT2203 is safe and well tolerated.
However, both the clinical and mycological responses for MAT2203
did not meet the Company’s expectations and were below that of
fluconazole, the guideline recommended therapy for the treatment of
VVC.
Matinas management will host a conference call
and live webcast for investors, analysts and other interested
parties to review the topline data today, June 26, 2017 at 8:30
a.m. ET (details below).
“In this study, we were able to further
demonstrate that oral delivery of encochleated amphotericin B is
safe and well tolerated without the liver and kidney toxicities
typically seen with administration of intravenous amphotericin B.
In the context of our overall development program for MAT2203, this
Phase 2 study was not designed or powered to support an indication
for the treatment of VVC and therefore supplant fluconazole as the
standard of care. Instead, our goal was, in addition to further
establishing the safety and tolerability of MAT2203, to demonstrate
efficacy of MAT2203 in a non-life threatening fungal infection
consistent with the development of other anti-fungal therapies, as
we prepared MAT2203 to enter a pivotal trial in the prevention of
invasive fungal infections. In this particular study, we were not
successful in demonstrating meaningful clinical or mycological
response of MAT2203 as compared to fluconazole. However, upon
review of the improvements over baseline of the composite clinical
score of patient signs and symptoms at Day 5 and Day 12 at both the
200 mg and 400 mg arms, we were pleased to see what we believe
could indicate clinical response which may provide support for the
systemic delivery of MAT2203 to the site of infection,” stated
Roelof Rongen, Chief Executive Officer of Matinas BioPharma.
This completed proof-of-concept Phase 2 study of
MAT2203 was a multi-center, randomized trial with the primary
objective to evaluate the safety of two orally administered doses
(200 mg and 400 mg) of MAT2203 compared to 150 mg of fluconazole in
137 women in the safety population. Secondary efficacy objectives
were to assess the clinical cure rate and the mycological
eradication rate of oral CAMB at the test of cure visit (Day 12)
compared with fluconazole in 79 women with confirmed vulvovaginal
candidiasis at baseline in the modified intent to treat population,
and tertiary objectives were to assess pharmacokinetics (PK) of
CAMB after 5 days of oral administration.
There were no serious adverse events reported in
the study and the majority of treatment emergent adverse events
(TEAEs) were mild in severity and unrelated to study drug.
Drug-related TEAEs of orally-delivered encochleated amphotericin B
should be evaluated in the context of the side effects of
IV-administered unencochleated amphotericin B, which is well known
for its severe and potentially lethal side effects. Drug-related
TEAEs occurred in only 20% of 200 mg patients and 18% of 400 mg
patients. The most frequently occurring drug-related TEAEs in the
MAT2203 groups were gastrointestinal and mild in nature.
Drug-related TEAEs occurred in 2% of patients on fluconazole.
“Importantly, we continue to believe in the
potential of our unique platform technology as it relates to the
development of MAT2203 for the prevention and treatment of invasive
fungal infections. In looking at the data generated from this study
contrasted with the data from our ongoing NIH Phase 2 study, it
appears that both higher doses and longer duration of therapy,
which yielded a significant clinical response in the
immunocompromised patients in the NIH study, could be important
factors in demonstrating efficacy in mucosal candidiasis.
Accordingly, we believe that utilizing a higher dose for a longer
duration in this study may have resulted in improvement in overall
clinical and mycological responses. Despite the results from this
single study of MAT2203 at low doses and for a short duration, we
believe that the extensive existing body of preclinical and human
data established to date with our cochleate technology warrants
continued development of MAT2203, and we look forward to advancing
MAT2203 to build an overall efficacy data package,” added Mr.
Rongen.
Efficacy endpoints included evaluation of
clinical and mycological response. Clinical response was evaluated
using a composite scoring system that compared signs and symptoms
of VVC from baseline to test of cure (Day 12). Signs and symptoms
included itching, burning, irritation, erythema, edema, or
excoriation. MAT2203 demonstrated a clinical cure in 52% of
patients at 200 mg/day and 55% of patients at 400 mg/day, compared
to 75% of patients on fluconazole. In the mycology outcome, 36% of
patients in the 200 mg arm and 32% in the 400 mg arm experienced
eradication, compared to 84% of patients in the fluconazole arm. In
the composite clinical cure score of signs and symptoms at Day 12,
MAT2203 demonstrated an 81% improvement in clinical symptoms at 200
mg/day, 80% improvement at 400 mg/day, compared to 94% improvement
in clinical symptoms for the patients on fluconazole.
“We believe that with this study, we continue to
generate important data about MAT2203 and the unique mechanism of
action of the cochleate technology, which will be invaluable as we
design additional studies in support of this development program,”
stated Raphael J. Mannino, Chief Scientific Officer of the
Company.
The Company will be receiving additional data
from the study over the next few months and intends to continue to
evaluate such data from this study as it becomes available,
including data on pharmacokinetics, and will provide guidance on
details and timing of additional development plans for MAT2203
during the third quarter of 2017.
Conference Call and Webcast Information
Matinas will host a conference call and live
webcast for investors, analysts and other interested parties on
Monday, June 26, 2017 at 8:30 am ET to provide an update and
overview for the clinical development of MAT2203.
To participate in the call, please dial
877-407-5976 (domestic) or 412-902-0031 (international). The live
webcast will be accessible on the Events page of the Investors
section of Matinas’ website, www.matinasbiopharma.com, and will be
archived for 60 days. Interested parties can click here to access
the webcast directly.
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 platform 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 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