Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated
to significantly improving the health and well-being of patients
affected by obesity and complex metabolic disorders, today
announced that the Company has recently initiated dosing in the
multiple ascending dose (MAD) cohorts of its ongoing Phase 1
clinical trial of ZGN-1061. The initiation of the MAD portion was
triggered following a review of the initial safety and tolerability
data from the first two cohorts of the single ascending dose (SAD)
portion of the clinical trial. ZGN-1061 is a second-generation,
differentiated MetAP2 inhibitor in development for severe and
complicated obesity indications.
“For the last decade Zafgen has been studying
the MetAP2 pathway to inform the development of molecules that will
leverage the powerful benefits of MetAP2 inhibition, while
minimizing off-target effects. Based on this work we have optimized
ZGN-1061 to deliver an efficacy and safety profile appropriate for
development in prevalent obesity-related disorders,” said Thomas
Hughes, Ph.D., President and Chief Executive Officer of
Zafgen. “This clinical trial is an important first step as we
look to validate the clinical profile of ZGN-1061. Initial results
show ZGN-1061 exhibits pharmacokinetic properties in humans within
our specified target range, translating to encouraging early safety
and tolerability that support our plans for continued development
of this promising candidate.”
The Phase 1 clinical trial is evaluating safety,
tolerability, and weight loss efficacy over four weeks of
treatment. The clinical trial includes a SAD portion, which will
enroll up to 48 healthy subjects across up to six cohorts of single
escalating doses of ZGN-1061. The clinical trial also includes a
MAD portion, which is evaluating twice-weekly ZGN-1061 over four
weeks in up to 24 obese subjects. Key elements of the clinical
trial involve evaluation of the uptake and elimination of ZGN-1061,
or pharmacokinetics, and evaluation of endpoints related to blood
coagulation. The Company continues to expect top-line data from the
clinical trial by the end of the first quarter of 2017.
ZGN-1061, is a fumagillin-class MetAP2 inhibitor
that originated from Zafgen's discovery program as part of a
multi-year campaign to identify novel compounds that avoided
limiting preclinical safety concerns observed with its
first-generation MetAP2 inhibitor, beloranib, including
teratogenicity and adverse effects on testicular function. The
compound has metabolic efficacy, potency, and range of activity in
animal models of obesity similar to beloranib, but displays highly
differentiated safety properties and a reduced potential to impact
thrombosis, supporting the value of the compound as a more highly
optimized MetAP2 inhibitor.
“The clinical trial is progressing well, and we
are particularly encouraged that there have been no significant
safety signals or tolerability concerns observed in patients
treated to date,” stated Dennis Kim, M.D., Chief Medical Officer of
Zafgen. “We look forward to further advancing this clinical trial,
the results of which will provide us with important insights on the
potential of ZGN-1061 in severe and complicated obesity, and help
inform the doses, design, and patient population for our Phase 2
program.”
About ZGN-1061
ZGN-1061 is a fumagillin-class, injectable small
molecule second generation MetAP2 inhibitor that modulates the
activity of key cellular processes that control the body's ability
to make and store fat, and utilize fat and glucose as an energy
source. In preclinical studies, ZGN-1061 has demonstrated promising
efficacy and potency in animal models of obesity, with an improved
pharmacokinetic profile and safety margin relative to previous
molecules in the MetAP2 class. ZGN-1061 is anticipated to help
reduce hunger and restore balance to fat metabolism, enabling
calories to once again be used as a productive energy source,
leading to weight loss and improved metabolic control. ZGN-1061 is
currently in Phase 1 clinical development. Zafgen holds exclusive
worldwide rights for the development and commercialization of
ZGN-1061.
About Zafgen
Zafgen (Nasdaq:ZFGN) is a biopharmaceutical
company dedicated to significantly improving the health and
well-being of patients affected by obesity and complex metabolic
disorders. Zafgen is focused on developing novel therapeutics that
treat the underlying biological mechanisms of severe and
complicated obesity through the MetAP2 pathway. Zafgen has
pioneered the study of MetAP2 inhibitors in both common and rare
forms of obesity. Zafgen's lead product candidate is ZGN-1061,
which is a novel, first-in-class, twice-weekly subcutaneous
injection. Zafgen is also developing ZGN-839, a liver-targeted
MetAP2 inhibitor, for the treatment of nonalcoholic
steatohepatitis, or NASH, and abdominal obesity. Zafgen aspires to
improve the lives of patients through targeted treatments and has
assembled a team accomplished in bringing therapies to patients
affected by metabolic diseases.
Safe Harbor Statement
Various statements in this release concerning Zafgen's future
expectations, plans and prospects, including without limitation,
Zafgen's expectations regarding the use of ZGN-1061 and other
MetAP2 inhibitors as treatments for severe and complicated obesity
and Zafgen's expectations with respect to the timing and success of
its preclinical studies and clinical trials of ZGN-1061 and its
other product candidates, including timing for reporting results
from such clinical trials may constitute forward-looking statements
for the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. Forward-looking statements can be identified by
terminology such as "anticipate," "believe," "could," "could
increase the likelihood," "estimate," "expect," "intend," "is
planned," "may," "should," "will," "will enable," "would be
expected," "look forward," "may provide," "would" or similar terms,
variations of such terms or the negative of those terms. Actual
results may differ materially from those indicated by these
forward-looking statements as a result of various important
factors, including, without limitation, Zafgen's ability to
successfully demonstrate the efficacy and safety of ZGN-1061 and
its other product candidates, the preclinical and clinical results
for ZGN-1061 and its other product candidates, which may not
support further development and marketing approval, actions of
regulatory agencies, which may affect the initiation, timing and
progress of preclinical studies and clinical trials of its product
candidates, Zafgen's ability to obtain, maintain and protect its
intellectual property, Zafgen's ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties, competition from others developing
products for similar uses, Zafgen's ability to manage operating
expenses, Zafgen's ability to obtain additional funding to support
its business activities when needed and establish and maintain
strategic business alliances and new business initiatives, Zafgen's
dependence on third parties for development, manufacture,
marketing, sales and distribution of product candidates, the
outcome of litigation, and unexpected expenditures, as well as
those risks more fully discussed in the section entitled "Risk
Factors" in Zafgen's most recent Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission, as well as
discussions of potential risks, uncertainties, and other important
factors in Zafgen's subsequent filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent Zafgen's views only as of today and should not be relied
upon as representing its views as of any subsequent date. Zafgen
explicitly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Media/Investor Relations Contact:
Zafgen, Inc.
Patricia Allen
Chief Financial Officer
617-648-9792
Argot Partners
Investor Relations
Laura Perry or Glenn Garmont
212-600-1902
laura@argotpartners.com
glenn@argotpartners.com
Spectrum Science
Media Relations
Michelle Strier
202-587-2582
mstrier@spectrumscience.com
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