Zafgen Announces Regulatory Update on ZGN-1061
30 Mai 2019 - 1:00PM
Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical
company leveraging its proprietary knowledge of MetAP2 systems
biology to develop novel therapies for patients affected by a range
of metabolic diseases, today announced the receipt of minutes from
its Type A meeting with the U.S. Food and Drug Administration (FDA)
regarding the clinical hold for ZGN-1061.
Zafgen provided key new data in advance of the meeting,
including newly developed in vitro assays of human plasma
coagulation using endothelial cells and assessment of tissue factor
expression with endothelial cells, and other supportive new assays.
The Company is working with FDA to gain alignment on an in vivo
animal model to confirm relevant safety margins as a next step
toward resolving the clinical hold. Zafgen will be prepared to
rapidly implement the agreed upon work.
“The Type A meeting with the FDA for ZGN-1061 was marked by
constructive dialogue and progress driven by the important new data
that the team worked diligently to provide to inform the
discussion. This effort for Zafgen was led by highly experienced
members of our team, Dr. Priya Singhal, our new Head of R&D,
and Lisa Percival, our Vice President of Regulatory,” said Jeffrey
Hatfield, Chief Executive Officer. “We believe the new in vitro
data generated was encouraging, and the FDA was helpful with
guidance regarding data needed to move forward in type 2
diabetes.”
Additionally, the Company is evaluating serious, rare disease
indications that have few or no approved therapies in which
ZGN-1061 could potentially benefit patients. The FDA was supportive
of Zafgen seeking guidance on a second investigational new drug
application (IND) for ZGN-1061, as appropriate.
Zafgen will provide an update on development plans by the end of
the third quarter of 2019.
About ZafgenZafgen (Nasdaq:ZFGN) is a
clinical-stage biopharmaceutical company leveraging its proprietary
MetAP2 biology platform to develop novel therapies for patients
affected by complex metabolic diseases. Zafgen has pioneered the
study of MetAP2 inhibitors in both common and rare metabolic
disorders. Learn more at www.zafgen.com.
Safe Harbor Statement Various statements
in this release concerning Zafgen's future expectations,
plans and prospects, including without
limitation, Zafgen's expectations regarding the
development and use of ZGN-1061 as a treatment for metabolic
diseases, nonclinical or clinical options to resolve the clinical
hold concerning ZGN-1061, and Zafgen's expectations with
respect to the timing and success of its nonclinical studies and
clinical trials of ZGN-1061 and its other product candidates, and
Zafgen’s expectations regarding the length of its cash runway, may
constitute forward-looking statements for the purposes of the safe
harbor provisions of 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, ZGN-1258, ZGN-1345 and its
other product candidates and to differentiate them from first
generation MetAP2 inhibitors, such as beloranib, the nonclinical
and clinical results for ZGN-1061, ZGN-1258, ZGN-1345 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 nonclinical studies
and clinical trials of its product candidates, Zafgen's
ability to successfully engage with the FDA concerning the clinical
hold on a clinical trial of ZGN-1061 and to design and conduct a
nonclinical study or clinical trial demonstrating sufficient data
to exclude cardiovascular risk to an acceptable degree and
demonstrating the risk is reasonable to type 2 diabetes or other
indications, Zafgen’s ability to overcome the full clinical hold
placed on ZGN-1061 by the FDA and obtain regulatory approval,
Zafgen’s ability to continue to evaluate ZGN-1258 and to advance
the program in nonclinical and clinical development,
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 and establish and maintain
strategic business alliances and new business initiatives when
needed, Zafgen’s ability to attract and retain personnel,
Zafgen's dependence on third parties for development,
manufacture, marketing, sales and distribution of product
candidates, and unexpected expenditures, as well as those risks
more fully discussed in the section entitled "Risk Factors"
in Zafgen's most recent Annual Report on Form 10-K 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, including without
limitation Zafgen’s Quarterly Reports on Form 10-Q. 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 Contacts:Zafgen, Inc.
Patricia Allen Chief Financial Officer 617-648-9792
MediaKrystle GibbsTen Bridge Communications
krystle@tenbridgecommunications.com 508-479-6358
InvestorsJohn
WoolfordWestwickejohn.woolford@westwicke.com443-213-0506
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