Zafgen Provides Update on Investigational New Drug Application for ZGN-1061
November 26 2018 - 7:00AM
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 that the Company received a
letter last week from the U.S. Food and Drug Administration (FDA)
placing a clinical hold on the Investigational New Drug Application
(IND) for its first U.S. clinical trial of ZGN-1061, the Company’s
second-generation, investigational MetAP2 inhibitor currently in
development for the treatment of type 2 diabetes.
The FDA cited the possibility of cardiovascular (CV) safety risk
based on the Company’s prior compound and outlined multiple
potential paths for moving forward, including nonclinical or
clinical options, to address these concerns in the ongoing
development of ZGN-1061. The Company plans to assess these options
and request a Type A meeting with the Agency to discuss next steps
with the program.
Zafgen continues to advance its ongoing ex-U.S. Phase 2 clinical
trial of ZGN-1061, which includes a 1.8 mg dose cohort. Dosing in
this clinical trial was recently completed and, while still
blinded, no CV safety signals have been observed to date. The
Company remains on track to report topline data from this cohort in
early 2019. Zafgen previously reported positive full 12-week
results for its initial cohort of this Phase 2 proof-of-concept
clinical trial, which included a range of doses up to 0.9 mg. In
that initial cohort, ZGN-1061 met all primary endpoints,
demonstrating proof-of-concept efficacy with robust A1C lowering
effects, and a favorable safety and tolerability profile generally
comparable to placebo, with no treatment-related serious adverse
events and no CV safety signals observed.
With the delay of additional clinical development for ZGN-1061,
Zafgen now expects the Company’s cash runway will extend through
calendar year 2020, with sufficient capital through multiple
milestones.
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 and is currently advancing programs for type 2
diabetes, Prader-Willi syndrome and liver diseases. 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 multiple
paths for moving forward, including nonclinical or clinical options
to resolve the clinical hold concerning the IND for a new proposed
clinical trial of ZGN-1061, the use of ZGN-1258, ZGN-1061, ZGN-1345
and other second-generation MetAP2 inhibitors as treatments for
metabolic diseases including PWS, type 2 diabetes, liver diseases
and obesity, Zafgen’s expectations regarding its capital
requirements and runway, 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, may
constitute forward-looking statements for 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 engage with
the FDA concerning the clinical hold on a clinical trial of
ZGN-1061, to design and conduct a nonclinical study or clinical
trial demonstrating sufficient data to exclude cardiovascular risk
to an acceptable degree, collect and analyze medical history and
medical events from PATH for PWS participants, the capacity for
such data to inform clinical trial design and potential areas for
future study, Zafgen’s ability to successfully demonstrate the
efficacy and safety of ZGN-1258, ZGN-1061, ZGN-1345 and its other
product candidates and to differentiate ZGN-1258, ZGN-1061,
ZGN-1345 and its other product candidates from first generation
MetAP2 inhibitors, such as beloranib, the nonclinical and clinical
results for ZGN-1258, ZGN-1061, 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
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 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 WoolfordWestwicke
Partnersjohn.woolford@westwicke.com443-213-0506
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