- Data Demonstrate Dose-Dependent Beneficial
Impact of ZGN-1061 on Glucose Tolerance, Body Weight and
Cardiometabolic Markers-
Zafgen, Inc. (Nasdaq:ZFGN), today announced the presentation of
data for ZGN-1061 at the 53rd Annual Meeting of the European
Association for the Study of Diabetes being held in Lisbon,
Portugal from September 11-15, 2017. ZGN-1061, the Company's
second-generation MetAP2 inhibitor, is advancing toward a Phase 2
clinical trial in patients with type 2 diabetes. The poster
presentations are available on the "Events & Presentations"
section of the Zafgen website.
The data presented includes previously presented
data from the Phase 1 clinical trial of ZGN-1061, as well as new
preclinical data demonstrating the dose-dependent effect of
ZGN-1061 on glucose tolerance, weight loss, and several metabolic
markers in diet-induced obese mice.
“The results presented today underscore the
potential of ZGN-1061 to positively impact glycemic control, body
weight and other metabolic parameters, consistent with MetAP2
inhibition," stated Thomas Hughes, Ph.D., President and Chief
Executive Officer of Zafgen. “Importantly, the new preclinical
data illustrate that the improvement in glucose tolerance produced
by ZGN-1061 occurs independently from weight loss benefits seen
with the compound. These results reinforce our confidence in the
program as we advance into a Phase 2 clinical trial of ZGN-1061 in
patients with type 2 diabetes.”
At the meeting, Zafgen presented new data
from a preclinical study evaluating ZGN-1061 in a mouse model of
obesity and insulin resistance. Highlights of the data include:
- ZGN-1061 produced dose-dependent improvements in glucose
tolerance and insulin levels in diet induced obese mice.
- ZGN-1061 produced a dose-dependent reduction in body weight
that was primarily due to loss of fat mass.
- The improvements in glucose tolerance and insulin levels seen
with ZGN-1061 also occurred with low dose levels which did not
result in weight change and suggest these glucose homeostatic
benefits can be dissociated, at least in part, from a weight loss
effect or food intake effect.
- Improvements in metabolic biomarkers, including non-esterified
fatty acids, ketone bodies (β-hydroxybutyrate), and leptin, were
consistent with loss of fat mass as well as increased fat
mobilization and oxidation.
Zafgen also presented findings from the company’s Phase 1
clinical trial of ZGN-1061. As previously reported, the data show
that ZGN-1061 treatment causes improvements across multiple
metabolic measures consistent with MetAP2 inhibition, demonstrates
rapid drug absorption and clearance, and has a favorable safety
profile with no evidence of prothrombotic effects.
About ZGN-1061
ZGN-1061 is a fumagillin-class, injectable small molecule second
generation MetAP2 inhibitor that was advanced into development due
to its unique properties that maximize impact on metabolic
parameters relevant to the treatment of type 2 diabetes and other
related metabolic disorders. In preclinical studies, ZGN-1061 has
demonstrated promising efficacy in animal models of type 2 diabetes
and obesity, with an improved pharmacokinetic profile and safety
margin relative to previous molecules in the MetAP2 inhibitor
class. As demonstrated clinically for MetAP2 inhibitors, ZGN-1061
is anticipated to improve glycemic control while also helping to
restore balance to fat metabolism, enabling calories to once again
be used as a productive energy source, leading to improved
metabolic control and long-term weight loss. Zafgen recently
completed its first Phase 1 clinical trial of ZGN-1061, and is
planning to advance the compound to Phase 2 clinical testing in
patients with type 2 diabetes who are overweight or obese. 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 metabolic diseases including type 2 diabetes and
obesity. Zafgen is focused on developing novel therapeutics that
treat the underlying biological mechanisms of metabolic diseases
through the MetAP2 pathway. Zafgen has pioneered the study of
MetAP2 inhibitors in both common and rare forms of obesity, and in
patients affected by type 2 diabetes. Zafgen's lead product
candidate is ZGN-1061, which is a novel, first-in-class,
subcutaneous injection. 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 metabolic diseases including
type 2 diabetes and obesity, ZGN-1061's improved safety margin,
including as it relates to prothrombotic characteristics, compared
to first generation MetAP2 inhibitors, such as over beloranib, 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, 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 and to differentiate ZGN-1061 and its
other product candidates from first generation MetAP2 inhibitors,
such as beloranib, 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 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, 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 AllenChief Financial
Officer617-648-9792
Argot PartnersInvestor RelationsLaura Perry
212-600-1902laura@argotpartners.com
Spectrum ScienceMedia RelationsMichelle
Strier202-587-2582mstrier@spectrumscience.com
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