Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology
company focused on discovering and developing novel biologic
therapeutics to treat rare immune-mediated diseases, announced the
launch of an adaptive Phase 2/3 clinical study for its FcRn
inhibitor nipocalimab (M281) in warm Autoimmune Hemolytic Anemia
(wAIHA). This follows the acceptance of its Investigational New
Drug (IND) application by the U.S. Food and Drug Administration.
The FDA has also granted Fast Track Designation for nipocalimab in
wAIHA.
“wAIHA is a rare autoimmune disease with high unmet
medical need and no labelled treatments. By targeting FcRn as a
mechanism to reduce circulating levels of pathogenic IgG
antibodies, nipocalimab could offer significant potential benefit
for patients with this devastating severe immune mediated disease,”
said Craig Wheeler, President and Chief Executive Officer of
Momenta Pharmaceuticals. “This study initiation is an important
milestone for Momenta, marking the start of our third clinical
study of nipocalimab in auto and alloimmune diseases. To date,
nipocalimab has exhibited a best-in-class profile and we continue
to believe in its broad market potential across a range of
immune-mediated diseases. Moreover, if successful, this adaptive
Phase 2/3 study could serve as a pivotal study which could enable
nipocalimab to be the first treatment option for wAIHA
patients.”
“There are no approved treatments for warm
autoimmune hemolytic anemia and the current treatment options are
associated with significant side effects,” said Howard A. Liebman,
MD, MA, USC Norris Comprehensive Cancer Hospital. “Patients and
families are seeking out new treatments without potential serious
complicating factors.” This randomized, double blind,
placebo-controlled, multi-center, adaptive Phase 2/3 clinical trial
will investigate the efficacy, safety and tolerability of
nipocalimab (M281) in patients with wAIHA. Often used in rare
diseases, adaptive study designs allow for modification of the
study design and hypotheses based on interim analyses of the data.
This strategy allows for greater flexibility and efficiencies in
study design, which can benefit both sponsors and patients in
diseases with large unmet need, as the amount of useful data
collected is maximized.
About Warm Autoimmune Hemolytic
Anemia
wAIHA is a rare autoimmune hemolytic anemia
characterized by the destruction of red blood cells due to the
presence of pathogenic IgG autoantibodies. Destruction of red blood
cells results in severe anemia, leading to weakness and fatigue. As
the disease progresses, and without safe and effective treatment,
serious complications can develop. Up to 8% of wAIHA patients may
die prematurely, with those experiencing active and uncontrolled
hemolysis most at risk. Rates as high as 30% have been observed for
wAIHA patients with severe disease admitted to an ICU. All suffer
from serious complications from the disease and its associated
treatments.
Nipocalimab (M281) Overview
Using proprietary antibody engineering technology,
Momenta has developed nipocalimab (M281), a fully human, anti-FcRn,
aglycosylated IgG1 monoclonal antibody.
In patients with wAIHA, nipocalimab is expected to
rapidly ameliorate the physical and laboratory manifestations of
the disease by blocking FcRn-mediated recycling of IgG and reducing
circulating levels of antibodies, including the pathogenic
autoantibodies that cause wAIHA.
Momenta previously reported positive data showing
safety, tolerability and proof of mechanism for nipocalimab in a
Phase 1 single ascending dose (SAD) and multiple ascending dose
(MAD) study of normal human volunteers. Over the 98-day MAD
study, nipocalimab exhibited no serious adverse events, was well
tolerated, and decreased circulating IgG levels up to 89% with a
mean reduction of 84%.Nipocalimab is also being evaluated in two
ongoing Phase 2 trials: the Vivacity-MG clinical trial, a
randomized, double-blinded, placebo-controlled multi-dose trial in
60 generalized myasthenia gravis patients where top line data is
anticipated in the second or third quarter of 2020; and the Unity
trial, an open label Phase 2 clinical trial of nipocalimab in 15
pregnant women at high risk for early onset severe hemolytic
disease of the fetus and newborn (HDFN), with top line data
anticipated in 2021. Additional clinical trial information can be
found here and patients and families can find more information at
www.momentapharma.com.
About the FDA’s Fast Track
Program
The FDA’s Fast Track program is designed to
facilitate the development and expedite the review of drugs that
treat serious conditions and fill unmet medical needs. A drug
granted Fast Track Designation may be eligible for several
benefits, including more frequent meetings and communications with
the FDA and, if certain criteria are met, the potential for
Accelerated Approval, Priority Review or Rolling Review of a
Biologics License Application (BLA).
About Momenta
Momenta Pharmaceuticals is a biotechnology company
with a validated innovative scientific platform focused on
discovering and developing novel therapeutics to treat rare,
immune-mediated diseases and advancing its late stage biosimilar
portfolio. The company is headquartered in Cambridge, MA.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does
not form a part of this press release.
The Company’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 timing
of our regulatory filings for clinical development and marketing
approval; the timing of regulatory approval and launch of our
product candidates; development timelines; the Company’s ability to
meet its development and strategic goals; market potential and
revenue of our products and product candidates, design, timing and
goals of clinical trials and the availability, timing and
announcement of data and results; the use, efficacy, safety,
potency, 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 those referred to under the section
"Risk Factors" in the Company's Quarterly Report on Form 10-Q for
the quarter ended March 31, 2019 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: |
MEDIA CONTACT: |
Patty Eisenhaur |
Karen Sharma |
Momenta Pharmaceuticals |
MacDougall Biomedical
Communications |
1-617-395-5189 |
1-781-235-3060 |
IR@momentapharma.com |
Momenta@macbiocom.com |
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