Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a
biotechnology company focused on discovering and developing novel
biologic therapeutics to treat rare immune-mediated diseases, today
announced new preclinical data for M281, its potentially
best-in-class anti-FcRn antibody, was published in the
American Journal of Obstetrics & Gynecology.
The data show that M281 inhibits maternal to fetal IgG transfer in
the human ex vivo term placental perfusion model, while showing
minimal transfer itself to fetal circulation.
The published study entitled, “M281, an anti-FcRn antibody,
inhibits IgG transfer in a human ex vivo placental perfusion
model,” was conducted in collaboration with the laboratory of Dr.
Tatiana Nanovskaya at the University of Texas Medical Branch.
“This study in the gold standard model of the human term
placenta showed that M281 has the potential to block the transfer
of IgG from maternal to fetal circulation through late pregnancy.
Prevention of maternal to fetal transfer of pathogenic
antibodies through late pregnancy, the period with the highest
placental IgG transfer, is a mechanism that may benefit alloimmune
and autoimmune diseases of the fetus and newborn which can be
potentially life threatening,” said Santiago Arroyo, M.D., Ph.D.,
Senior Vice President of Development and Chief Medical Officer of
Momenta Pharmaceuticals. “Additionally, M281 itself showed
insignificant transfer to the fetal circulation, which could
minimize exposure of the fetus to M281. With lowering of systemic
IgG, as seen in our Phase 1 study, and the potential to block
placental transfer of pathogenic antibodies, we believe M281 has
broad potential to treat alloimmune and autoimmune diseases of
pregnancy, as well as a number of autoimmune diseases.
“We are also pleased to announce that we obtained appropriate
regulatory approvals in the U.S., Canada, and several EU countries,
and that clinical sites are in the process of being activated
globally for our multicenter clinical trial evaluating M281 in the
prevention of early antenatal hemolytic disease of the fetus and
newborn, a disease with high fetal mortality and infant morbidity,”
continued Dr. Arroyo.
About M281 M281 is a fully human anti-neonatal
Fc receptor (FcRn), aglycosylated immunoglobulin G (IgG1)
monoclonal antibody, engineered to reduce circulating pathogenic
IgG antibodies by blocking endogenous IgG recycling via FcRn.
Momenta previously reported positive data showing safety,
tolerability and proof of mechanism for M281 in a Phase 1 single
ascending dose (SAD) and multiple ascending dose (MAD) study of
normal human volunteers. Over the 98-day MAD study, M281 exhibited
no serious adverse events, was well tolerated, and decreased
circulating IgG levels up to 89% with a mean reduction of 84%.1
M281 is currently being evaluated in Phase 2 studies in generalized
myasthenia gravis2 and in early onset antenatal HDFN3 with plans
for an additional Phase 2 autoimmune study later this year.
About Hemolytic Disease of the Fetus and Newborn
(HDFN) Hemolytic disease of the fetus and newborn is a
rare and potentially life-threatening condition that affects
approximately 4,000-8,000 pregnancies each year in the U.S. alone.
The disease is caused by antibodies from the mother which target
proteins (also called antigens) on the fetal red blood cells (a
process known as red cell alloimmunization). The most common
antigen is RhD, although other antigens such as Rhc, RhE and Kell
may also be involved in the process.
During pregnancy, antibodies can cross the placenta and bind to
the antigens on the surface of the fetus’ red blood cells, leading
to fetal red blood cell destruction and anemia. Anemia causes less
oxygen to be delivered to all the fetal tissues and can lead to
organ damage and ultimately lead to fetal heart failure and even
fetal death. In addition, severe HDFN can, in some cases, result in
long-term neurodevelopmental delay including cerebral palsy and
bilateral deafness. Intrauterine blood transfusions are the current
standard of care, as there are no FDA-approved drugs to treat
women at risk of HDFN.
About Momenta Momenta is a biotechnology
company with a validated innovative scientific platform focused on
discovering and developing novel therapeutics to treat rare,
immune-mediated diseases. Momenta’s product candidate, M281, is a
potentially best-in-class anti-FcRn antibody; M254, is a
hyper-sialylated human immunoglobulin (hsIgG) designed as a high
potency alternative to intravenous immunoglobulin (IVIg); and M230
(CSL730), is a potential first-in-class novel recombinant Fc
multimer being developed in collaboration with CSL. Momenta also
has a focused pipeline of two biosimilar candidates: M923,
Momenta’s wholly-owned proposed biosimilar to HUMIRA®, and M710, a
proposed biosimilar to EYLEA® being developed in collaboration
with Mylan. Momenta’s two FDA-approved complex generic
products, enoxaparin sodium injection and Glatopa® (glatiramer
acetate injection), are marketed by its collaboration
partner, Sandoz.
To learn more about Momenta, please
visit www.momentapharma.com, which does not form a part of
this press release. Momenta’s logo, trademarks, and service marks
are the property of Momenta Pharmaceuticals, Inc. All
other trade names, trademarks, or service marks are property of
their respective owners.
Forward-Looking Statements Statements in
this press release regarding management's future expectations,
beliefs, intentions, goals, strategies, plans or prospects, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including but not limited
to statements about the design, timing and goals of clinical
trials, including gold standard models, and the availability and
timing of reporting results; the use efficacy, safety,
tolerability, convenience and commercial potential of our product
candidates, including their potential as best-in-class agents.
Forward-looking statements may be identified by words such as
"believe," "continue," “plan to”, "potential," "will," and other
similar words or expressions, or the negative of these words or
similar words or expressions. Such forward-looking statements
involve known and unknown risks, uncertainties and other important
factors, including the risk of the unpredictable nature of early
stage development efforts for our product candidates; safety,
efficacy or tolerability problems with our product candidates;
unexpected adverse clinical trial results; and those referred
to under the section "Risk Factors" in the Company's Annual Report
on Form 10-K for the year ended December 31, 2018 filed
with the Securities and Exchange Commission, as well as other
documents that may be filed by the Company from time to time with
the Securities and Exchange Commission. As a result of such
risks, uncertainties and factors, the Company's actual results may
differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. The Company is providing the
information in this press release as of this date and assumes no
obligations to update the information included in this press
release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
INVESTOR CONTACT: Patty
Eisenhaur Momenta Pharmaceuticals 1-617-395-5189
IR@momentapharma.com |
MEDIA CONTACT: Karen
Sharma MacDougall Biomedical Communications 1-781-235-3060
Momenta@macbiocom.com |
1 Clinical Pharmacology & Therapeutics. November 2018
“M281, an Anti-FcRn Antibody: Pharmacodynamics, Pharmacokinetics,
and Safety Across the Full Range of IgG Reduction in a
First-in-Human Study”. Ling LE, Hillson JL, Tiessen RG, Bosje
T, van Iersel MP, Nix DJ, Markowitz L, Cilfone NA, Duffner J,
Streisand JB, Manning AM, Arroyo S. Clin Pharmacol Ther. 2018
Nov 6. doi: 10.1002/cpt.1276. [Epub ahead of print].2
Clinicaltrials.gov identifier NCT037725873 Clinicaltrials.gov
identifier NCT03842189
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