Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on developing next
generation therapeutics to advance standards of care in areas of
significant unmet medical need, today announced topline results
from the ENHANCE-IT study (Pharmacodynamic Effects of a Free-fatty
Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in
Adults with Hypertriglyceridemia), the second head-to-head
comparative study of LYPDISO™ vs. Vascepa®.
In ENHANCE-IT, the key parameters evaluated
included triglycerides (TGs), other lipoprotein and inflammatory
markers, and blood levels of omega-3 fatty acids. The primary
endpoint was the percent change from baseline to end-of-treatment
in TG and superiority vs. Vascepa®.
Analyses were performed on a Pharmacodynamic
(PD) population (n=94; all subjects with evaluable measurements in
the two-treatment period, regardless of compliance with study drug
treatment), and a Per Protocol (PP) population (n=82; those
subjects in the PD population where overall compliance in both
treatment periods was at least 80% with no clinically important
protocol violations or deviations).
Plasma eicosapentaenoic acid (EPA)
concentrations were statistically significantly higher with
LYPDISO™, with a 46% relative percentage improvement in EPA blood
level concentrations over Vascepa®.
In the PD population there was a greater
reduction in TGs with LYPDISO™ (21.9%) as compared with Vascepa
(15.7%); this 39% relative improvement did not achieve statistical
significance. In the PP population, there were statistically
significant superior reductions in TGs, total cholesterol (TC),
VLDL cholesterol (VLDL-C) and high sensitivity C-reactive protein
(hsCRP), a well-established inflammatory marker.
“In this ENHANCE-IT study, LYPDISO™ achieved
significantly higher EPA levels, and lowered triglycerides as well
as hsCRP levels to a greater extent than Vascepa®,” said John J.P.
Kastelein, M.D., Ph.D., Matinas Scientific Advisory Board member
and Professor of Medicine at the Department of Vascular Medicine at
the Academic Medical Center of the University of Amsterdam, The
Netherlands. “The REDUCE-IT outcomes trial with Vascepa® has shown
that achieved EPA levels drive the cardiovascular protection
conferred by omega-3 fatty acids. The impressive
biomarker changes in ENHANCE-IT with LYPDISO™ support a potential
robust protection against cardiovascular disease in a pivotal Phase
3 outcome program.”
PLASMA FATTY ACIDS – Pharmacodynamic
(PD) Population
|
|
|
|
|
|
|
|
|
PD Population (n=94) |
Fatty Acid |
Baseline |
End-of-Treatment |
% Δ from Baseline |
Relative % Increase in Omega-3 level
Δ vs. Vascepa |
P-value |
(Median) |
(Median) |
(Median) |
|
LYPDISO™ |
Vascepa® |
LYPDISO™ |
Vascepa® |
LYPDISO™ |
Vascepa® |
EPA |
13.8 |
15.5 |
143 |
115 |
1009 |
690 |
46 |
% |
<0.001 |
(μg/mL) |
DPA |
20.3 |
20.7 |
57.8 |
50.3 |
183 |
145 |
26 |
% |
<0.001 |
(μg/mL) |
DHA |
48.6 |
50.2 |
49.7 |
48.1 |
4.5 |
-1.4 |
-- |
|
0.01 |
(μg/mL) |
EPA+DPA+DHA |
254 |
263 |
789 |
696 |
221 |
160 |
38 |
% |
<0.001 |
(nmol/mL ) |
The pharmacodynamic (PD)
population included all subjects for whom the estimation of PD
parameters was possible for 2 treatment periods.
Blood fatty acids levels increased with both
LYPDISO™ and Vascepa®, with similar findings in both the PD and the
PP populations. In the PD population the change in
fatty acid level with LYPDISO™ was 46% greater for EPA, 26% greater
for DPA, and 38% greater for total omega-3 levels than with
Vascepa® – all highly statistically significant. DHA levels
did not change meaningfully with either therapy but increased
slightly with LYPDISO™.
These findings highlight and further confirm the
greater bioavailability of LYPDISO’s free fatty acid formulation in
delivering substantially higher blood levels of EPA.
LIPOPROTEINS AND INFLAMMATORY MARKERS –
Pharmacodynamic (PD) Population
|
|
|
|
Variable* |
PD Population (N = 94) |
P-value |
Median % Δ |
LYPDISO™ |
Vascepa® |
TG |
-21.9 |
-15.7 |
0.27 |
TC |
-5.2 |
-2.9 |
0.17 |
LDL-C |
-5.4 |
-2.5 |
0.24 |
VLDL-C |
-16.3 |
-12.9 |
0.26 |
HDL-C |
-1.3 |
-1.5 |
0.69 |
Non-HDL-C |
-7.5 |
-3.8 |
0.19 |
Apo A1 |
-5.0 |
-3.5 |
0.46 |
Apo B |
-4.7 |
-1.9 |
0.54 |
Apo C3 |
-12.5 |
-10.5 |
0.53 |
PCSK9 |
-7.7 |
-6.1 |
0.80 |
hs-CRP |
-5.7 |
9.4 |
0.03 |
*Units of mg/dL for lipoprotein lipids, units of
ng/mL for PCSK9, and units of mg/L for hs-CRP
In the PD population LYPDISO™ reduced TGs by
21.9%, compared to a 15.7% reduction with Vascepa®; this difference
(a relative improvement of 39%) did not achieve statistical
significance.
There were similar numerical trends for all
other lipid parameters. Of note, LYPDISO™ did not raise LDL
cholesterol, as has been noted with other omega-3 formulations
containing DHA.
With regard to changes in hs-CRP, there were
statistically significant and superior differences between groups –
LYPDISO™ was associated with reductions in hs-CRP, while Vascepa
was associated with increases in hs-CRP.
LIPOPROTEINS AND INFLAMMATORY MARKERS –
Per Protocol (PP) Population
|
|
|
|
Variable |
*PP Population (N = 82) |
P-value |
Median % Δ |
LYPDISO™ |
Vascepa® |
TG |
- 20.9* |
-13.8 |
0.04 |
TC |
- 5.5* |
-2.3 |
0.04 |
LDL-C |
-5.6 |
-2.1 |
0.17 |
VLDL-C |
- 16.0* |
-10.9 |
0.03 |
HDL-C |
-1.6 |
-2.0 |
0.52 |
Non-HDL-C |
-7.6 |
-3.2 |
0.07 |
Apo A1 |
-5.0 |
-2.9 |
0.44 |
Apo B |
-4.1 |
-1.8 |
0.60 |
Apo C3 |
-11.1 |
-8.7 |
0.10 |
PCSK9 |
-6.7 |
-5.5 |
0.68 |
hs-CRP |
- 6.1* |
9.9 |
0.01 |
*The per protocol population
(PP) included all subjects in the
PD population for whom compliance for both study
periods was at least 80% and for whom no clinically important
protocol violations or deviations occurred during the trial.
*Statistically significant (superiority) vs.
Vascepa
In the prespecified PP population, there were
similar numerical trends as seen within the PD population; however,
given the more stringent compliance requirements for this
population, with less inter-individual variability, some of the
differences between groups now emerged as statistically
significant.
In the PP population, LYPDISO™ reduced TGs by
20.9%, compared to a 13.8% reduction with Vascepa®; this difference
was significant with a P-value of 0.04 (a relative improvement of
51%).
There were additional statistically significant
superior reductions with LYPDISO™ in total cholesterol
(5.5% vs 2.3%) and VLDL-C (16.0% vs 10.9%), with similar
non-significant numerical trends for the other lipid
parameters.
In the PP population, there were again
significant differences between groups in hs-CRP response.
“We are very grateful for all the hard work and
dedication on the part of the study team, the investigators, and
most importantly, the study subjects, especially during a
pandemic,” commented James J. Ferguson, M.D, FACC, FAHA, Chief
Medical Officer of Matinas. “These results have advanced our
understanding of the potential role of LYPDISO™ in the management
of patients with elevated triglycerides and cardiovascular
disease. Bioavailability is clearly an important
consideration in achieving higher EPA levels. Even when
Vascepa is given the advantage of being dosed with meals, LYPDISO™
provides TG lowering that is better than with Vascepa®, with no
increase in LDL-C, and with the added advantage of substantially
higher blood levels of EPA, total omega-3 and significant impact on
hs-CRP.”
“We are very pleased with the topline data from
ENHANCE-IT,” said Jerome D. Jabbour, Chief Executive Officer
of Matinas. “The statistically significant superior EPA levels
achieved with LYPDISO are an important differentiator vs. Vascepa®.
Although we did not achieve statistical significance on the primary
endpoint of triglycerides in the prespecified population, these
data point to the potential for robust cardiovascular risk
reduction with LYPDISO™. We further believe that these data could
position LYPDISO™ to potentially become the best-in-class
prescription omega-3 for the reduction of cardiovascular risk and
we will begin a process to identify a partner with which to
collaborate on a cardiovascular outcomes study.”
ENHANCE-IT was an open-label, randomized, 28-day
crossover study assessing the pharmacodynamic effects of LYPDISO
vs. Vascepa. The study enrolled 100 adult men and women with
elevated triglycerides (150-499 mg/dL), with approximately 58% of
study subjects with TGs ≥ 200 mg/dL. The study protocol involved
two 28-day treatment periods, with a washout period of at least 28
days in between treatments and was conducted at eight sites in the
U.S. LYPDISO and Vascepa were each administered as 2g twice daily
with food in accordance with currently approved Vascepa labeling.
Lipid parameters (triglycerides, Total-, LDL-, VLDL-, HDL-, and
non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9), a
key inflammatory marker (hs-CRP), and omega-3 blood levels were
measured at each baseline and at the end of each treatment period.
The primary endpoint measured the percent change from baseline to
end-of-treatment in plasma triglycerides.
Analysis of the safety database for ENHANCE-IT
remains ongoing. There were no serious adverse events reported for
this study and no dropouts related to study drug adverse
events.
Further analyses of additional clinical data
from the study are continuing and the Company expects to present
the full data from this study at upcoming scientific congresses and
in peer-reviewed journals over the course of the year.
Conference Call and Webcast
Information
Matinas will host a live conference call and
webcast today, February 1, 2021, at 8:00 a.m. Eastern Time to
discuss the results from ENHANCE-IT. A slide presentation will
accompany the call and webcast and will be available on the
Company’s website.
Participating on the conference call will be
members of the Matinas management team as well as Dr.
Kastelein.
The conference call can be accessed by dialing
877-407-5976 for participants in the U.S. or Canada and
412-902-0031 for international callers (reference passcode
13715418).
The conference call will also be webcast live on
Matinas' website, www.matinasbiopharma.com, under the ‘Investors’
section and will be archived there for 90 days.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on developing next generation
therapeutics to advance standards of care for patients in areas of
significant unmet medical need. Company leadership has a deep
history and knowledge of drug development and is supported by a
world-class team of scientific advisors.
LYPDISO, the Company’s lead product candidate
for the treatment of cardiovascular and metabolic conditions, is a
prescription-only omega-3 fatty acid-based composition, comprised
primarily of EPA and DPA, under development for
hypertriglyceridemia.
In addition, Matinas is developing a portfolio
of products based upon its proprietary lipid nanocrystal (LNC) drug
delivery platform, which can solve complex challenges relating to
the safe and effective delivery of potent medicines, making them
orally bioavailable, less toxic, and targeted to cells and
tissues.
MAT2203 is an oral, encochleated formulation of
the well-known, but highly toxic, antifungal medicine amphotericin
B, primarily used to treat serious invasive fungal infections.
MAT2203 is currently in a Phase 2 open-label, sequential cohort
study (EnACT) in HIV-infected patients with cryptococcal
meningitis. EnACT is currently enrolling patients in its second
cohort, with the next DSMB evaluation of safety and efficacy data
anticipated to occur in the middle of 2021.
MAT2501 is an oral, encochleated formulation of
the broad-spectrum aminoglycoside antibiotic medicine amikacin,
primarily used to treat chronic and acute bacterial infections. The
Company recently announced that it has been awarded up to $3.75
million from the Cystic Fibrosis Foundation (CFF) to support
development of MAT2501 toward an indication to treat nontuberculous
mycobacterial (NTM) lung disease, including infections in patients
with cystic fibrosis (CF).
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 ENHANCE-IT
study, the Company’s strategic focus and the future development of
its product candidates, including MAT9001, 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 ContactsPeter
VozzoWestwicke443-213-0505peter.vozzo@westwicke.com |
Ian CooneyDirector – Investor Relations &
Corporate DevelopmentMatinas Biopharma, Inc.(415)
722-4563icooney@matinasbiopharma.com
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