Data for the 1.8 mg dose demonstrated
meaningfully greater efficacy than the 0.9 mg dose
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 positive data for the second
cohort of its Phase 2 clinical trial of ZGN-1061, designed to
evaluate efficacy and safety in patients with type 2 diabetes and
the likely therapeutic dose range of ZGN-1061 up to 1.8 mg. The
clinical trial met all of its primary objectives at the 1.8 mg
dose, which included glycemic control, or change in A1C, and safety
and tolerability. The 12-week data demonstrated that treatment with
the 1.8 mg dose of ZGN-1061 produced substantially more improvement
in A1C than the 0.9 mg dose. Progressive and notable reduction in
body weight also occurred in patients treated with the 1.8 mg dose.
The data showed a favorable safety and tolerability profile for
ZGN-1061, with no treatment-related serious adverse events and no
cardiovascular (CV) safety signals observed.
“The results we’ve seen in our Phase 2 development of ZGN-1061,
and particularly with this latest 1.8 mg dose cohort, appear very
competitive with the currently available best-in-class
anti-diabetes therapies,” said Dennis Kim, M.D., Chief Medical
Officer, Zafgen. “All of the pharmacological actions of ZGN-1061
improve at the 1.8 mg dose level and, with its insulin-sensitizing
effects, we believe there is a clear opportunity for even greater
benefit with longer treatment duration given the effect we are
seeing at just 12 weeks.”
Treatment with ZGN-1061 demonstrated a statistically significant
reduction in A1C for 0.9 mg and 1.8 mg versus placebo at Week 12
(p=0.0003 and p<0.0001, respectively), with a 1.1% reduction in
A1C at the 1.8 mg dose relative to placebo. A1C levels continued to
decline with no waning of effect for both doses through Week 12.
Progressive weight reduction was also observed at the 1.8 mg dose
(p=0.0002), with placebo-corrected weight loss of 2.3 kg (5.1
pounds) seen at Week 12 with no evidence of waning effect.
Significant improvements were observed across multiple secondary
efficacy endpoints and various relevant metabolic biomarkers, as
well.
ZGN-1061 was generally safe and well-tolerated, with an adverse
event (AE) profile comparable to placebo. AEs were primarily mild
to moderate, and there were no treatment-related serious AEs in the
second cohort. The most frequent AEs at the 1.8 mg dose were upper
respiratory tract infection, injection site bruising, contusion and
nasopharyngitis. There were no meaningful elevations in mean
D-dimer concentrations across the dosing groups, including 1.8 mg,
as compared to baseline or placebo (excluding three patients who
experienced a hand fracture [placebo], gout [0.3 mg] and synovial
rupture [1.8 mg] unrelated to treatment) and no CV safety signals
observed.
“For many people with type 2 diabetes, A1C levels are not
adequately addressed by currently available treatments. MetAP2
inhibition offers a novel and unique mechanism of action and a
promising potential option in the treatment of this serious
disease,” said John Buse, M.D., Ph.D., Chief, Division of
Endocrinology at the University of North Carolina School of
Medicine. “The significant improvements in A1C and weight, two
cornerstone pathology parameters of type 2 diabetes, coupled with
very good tolerability and safety results for ZGN-1061, are
impressive at 12 weeks. So far, these results look very
encouraging.”
Zafgen previously reported positive full 12-week results for the
initial cohort of this Phase 2 proof-of-concept clinical trial that
included a range of doses up to 0.9 mg at the American Diabetes
Association’s 78th Scientific Sessions in June 2018.
“While there are many treatments available to address type 2
diabetes, the bar is rising for new options and innovative
mechanisms to address this complex disease and growing epidemic,”
said Jeffrey Hatfield, Chief Executive Officer, Zafgen. “The
profile of ZGN-1061, based on the Phase 2 clinical data, continues
to align with our mission to bring safe, effective and potentially
transformative treatments to patients who could benefit, and we
believe these data will strengthen the attractiveness of ZGN-1061
in our ongoing discussions with potential partners.”
Zafgen expects to present full results of the Phase 2 clinical
trial for ZGN-1061, including the 1.8 mg dose cohort, at an
upcoming medical meeting in 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 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, 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, 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 nonclinical
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 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, An ICR
Companyjohn.woolford@westwicke.com443-213-0506
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