Momenta Pharmaceuticals Initiates Phase 1 Trial of M281, an Anti-FcRn Monoclonal Antibody
June 09 2016 - 8:00AM
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology
company specializing in the characterization and engineering of
complex drugs, today announced the dosing of the first healthy
volunteers in a Phase 1 randomized, double-blind,
placebo-controlled, ascending-dose cohort study to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of
M281, an anti-FcRn monoclonal antibody, for the treatment of
autoimmune diseases.
"The preclinical data we presented at ASH in
December 2015 supported the evaluation of M281 as a strategy for
the rapid and reversible suppression of pathogenic
autoantibodies or alloantibodies in the setting of a variety
of autoimmune diseases,” said Jim Roach, M.D., Senior Vice
President of Development and Chief Medical Officer of Momenta
Pharmaceuticals. “The initiation of this trial advances our
initiative to develop a best-in-class monoclonal antibody for the
treatment of antibody-mediated diseases with high unmet medical
needs. We anticipate presenting the data from this trial in the
second half of 2017.”
M281 is a fully human IgG1 monoclonal antibody
that targets the IgG-binding site of FcRn. In preclinical models,
M281 potently antagonizes FcRn binding of IgGs and rapidly
diminishes circulating levels of IgG antibodies, the primary
pathogenic agent in a number of autoimmune diseases.
This study will enroll up to approximately 72
healthy volunteers depending on the number of cohorts enrolled.
Part 1 of the study will assess ascending doses of M281
administered as a single dose. Part 2 will assess ascending doses
of M281 administered as repeated weekly or twice-weekly doses over
28 days.
About Momenta Pharmaceuticals
Momenta Pharmaceuticals is a biotechnology company
specializing in the detailed structural analysis of complex drugs
and is headquartered in Cambridge, MA. Momenta is
applying its technology to the development of generic versions of
complex drugs, biosimilar and potentially interchangeable
biologics, and to the discovery and development of novel
therapeutics for oncology and autoimmune indications.
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, including without limitation statements regarding future
evaluation and development of M281, clinical trial design and the
timing of availability and presentation of data from clinical
trials, are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by terminology such as
“anticipate,” “initiative,” “potentially,” “strategy,” “target,”
“will” or similar terms, variations of such terms or the negative
of those terms. Such forward-looking statements involve known
and unknown risks, uncertainties and other factors referred to in
the Company's Quarterly Report on Form 10-Q for the quarter
ended March 31, 2016 filed with the Securities and
Exchange Commission under the section "Risk Factors," as well
as other documents that may be filed by Momenta 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. Momenta 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 Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
Business Development:
Momenta Pharmaceuticals
1-617-491-9700
businessdevelopment@momentapharma.com
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