Larger Phase 2b clinical trial in NASH cirrhosis
(NASH-CX) now completely enrolled
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and
cancer, today announced topline results from NASH-FX, its Phase 2a
clinical trial evaluating the efficacy, safety, and tolerability of
GR-MD-02 in 30 nonalcoholic steatohepatitis (NASH) patients with
advanced fibrosis. This exploratory, single site, short-treatment
(four months of therapy), randomized study did not meet its primary
biomarker endpoint as measured by LiverMultiScan (LMS, Perspectum
Diagnostics), a magnetic resonance imaging test that evaluates
inflammation and fibrosis. The trial also did not meet secondary
endpoints that measure liver stiffness as a surrogate for fibrosis,
with FibroScan® and magnetic resonance elastography (MRE). While
all patients had a baseline liver biopsy to establish the diagnosis
and fibrosis severity, liver biopsies were not performed at the end
of the study following treatment due to safety considerations
involved with liver biopsy-related risk in a short duration trial.
GR-MD-02 was found to be safe and well tolerated among the patient
population with no serious adverse events.
Importantly, Galectin simultaneously announced that the
principal focus of its research efforts—its larger scale, one-year,
multi-site trial in patients with NASH cirrhosis (NASH-CX)—has
completed enrollment one month early with 162 total subjects
(exceeding the target of 156 patients), allowing for reporting of
top-line results in December 2017. In further contrast to the
NASH-FX trial, the NASH-CX trial is being conducted with a primary
endpoint (hepatic venous pressure gradient (HVPG)) which the U.S.
Food and Drug Administration may view as an acceptable surrogate
for outcomes for registration trials in this patient
population.
“Although there was no apparent improvement in the three
non-invasive tests for assessment of liver fibrosis in this four
month pilot trial, inhibition of galectin-3 with GR-MD-02 remains
promising for treatment of NASH fibrosis,” said Stephen A.
Harrison, M.D., the principal investigator (PI) of the NASH-FX
trial, medical director of Pinnacle Clinical Research in San
Antonio, TX, and visiting professor of medicine at the University
of Oxford, UK. “In regard to the potential activity of GR-MD-02, it
is encouraging that there is an important clinical effect in
moderate-to-severe psoriasis, suggesting the compound has activity
in a human disease that can occur in association with NASH.”
Dr. Harrison, who is also the co-lead PI of the NASH-CX trial,
continued, “The NASH-FX trial was designed to follow up on limited
data from a Phase 1 study in NASH with advanced fibrosis, which
suggested that FibroScan® measurements may have improved with just
four doses of drug. However, as we have witnessed in other liver
fibrosis trials, the relatively short treatment duration of only
four months assessed in the NASH-FX was inadequate to see an
efficacy response. Therefore, we look forward to additional results
from the NASH-CX trial in which patients with NASH cirrhosis are
treated for one year.”
Naga Chalasani, M.D., the other co-lead PI of the NASH-CX trial
and chief of the Division of Gastroenterology and Hepatology at
Indiana University, said, “In my assessment, the results from the
NASH-FX trial do not diminish the significance of the NASH-CX
trial. Along with the safety and tolerability profile observed in
the NASH-FX trial, the different patient population, much larger
enrollment, rigorous study design and longer duration of therapy
offer compelling rationale to complete the NASH-CX trial.”
With over 1,600 drug doses administered there is now substantial
clinical trial experience with GR-MD-02. There is no evidence of
serious adverse effects related to the drug, highlighting the good
safety profile of the therapy in this patient population with
advanced stage disease. In the NASH-CX trial 64 patients have
already completed 6 months of dosing with a low drop-out rate of
only 3 patients prematurely exiting the trial.
In support for continued funding of the NASH-CX trial, a private
placement financing for $1.5 million from a single source was
signed on September 22, 2016. “It is encouraging that we have the
confidence of a highly-respected businessman such as Mr. Richard
Uihlein, who has now invested $1.5 million in Galectin through a
limited partnership investment fund, which adds to his current
significant stake in the company,” added Peter Traber, M.D.,
Galectin's president, chief executive officer and chief medical
officer. “Mr. Uihlein is further committed to helping the company
progress through the completion of the NASH-CX trial. We will
continue to pursue the additional funding required to support our
clinical development program.”
Conference Call Information Galectin will hold
a conference call today at 5:30 p.m. Eastern Time to provide an
update by Dr. Peter Traber and Dr. Stephen Harrison on the progress
of its lead development program.
Date: September 27, 2016Time:
5:30 p.m. Eastern TimeToll-Free:
1-888-317-6003Passcode:
4681161Webcast:
http://services.choruscall.com/links/galt160927.html
The full transcript of the conference call can be accessed on
the Investor Relations page of Galectin’s website,
http://investor.galectintherapeutics.com/, approximately 24 hours
after the completion of the call, and will be available for 60 days
following the call.
About NASH-CX TrialGalectin announced in August
the completion of patient recruitment ahead of original
expectations in the NASH-CX trial, its Phase 2b clinical trial with
GR-MD-02 in patients with NASH with cirrhosis. The Company has
enrolled 162 liver biopsy-confirmed NASH cirrhosis patents into the
treatment phase, with the original goal to enter 156 patients.
Enrolled patients are receiving either 8 mg/kg or 2 mg/kg of
GR-MD-02 or placebo every other week for 52 weeks, for a total of
26 doses. The primary study endpoint is a reduction of hepatic
venous pressure gradient (HVPG). Patients treated with GR-MD-02
will be evaluated to determine the change in HVPG as compared to
patients treated with placebo. HVPG will be correlated with
secondary endpoints of liver biopsy fibrosis staging at baseline
and the end of the trial, measurement of liver stiffness
(FibroScan®), and assessment of liver metabolism (13C-methacetin
breath test, Exalenz). The Company projects topline results of this
trial will be available in December 2017. More information on
the NASH-CX trial may be found in a post on Dr. Traber's blog, CEO
Perspectives and at www.clinicaltrials.gov.
About GR-MD-02 GR-MD-02 is a complex
carbohydrate drug that targets galectin-3, a critical protein in
the pathogenesis of fatty liver disease and fibrosis. Galectin-3
plays a major role in diseases that involve scarring of organs
including fibrotic disorders of the liver, lung, kidney, heart and
vascular system. The drug binds to galectin proteins and disrupts
their function. Preclinical data in animals have shown that
GR-MD-02 has robust treatment effects in reversing liver fibrosis
and cirrhosis.
About Fatty Liver Disease with Advanced Fibrosis and
Cirrhosis Non-alcoholic fatty liver disease (NAFLD) has
become the most common disease of the liver, generally associated
with the rise in obesity rates. NAFLD is characterized by the
presence of fat in the liver in people who consume little or no
alcohol, and when associated with inflammation and cell damage is
called non-alcoholic steatohepatitis (NASH). Over time, patients
with NASH can develop fibrosis, or scarring of the liver, which may
progress to severe fibrosis, called cirrhosis. Approximately one in
four people in the world have NAFLD, with 5% of those developing
cirrhosis, and 2% eventually dying of the disease. These data
translate into ~20,000,000 liver-related deaths among patients
currently alive with NAFLD. There are no drug therapies approved
for the treatment of NASH, liver fibrosis, or cirrhosis, for which
liver transplant is the only treatment available. A recent analyst
estimate indicated that by 2025 the worldwide market for NASH
treatments could approach $35 billion.
About Galectin Therapeutics Galectin
Therapeutics is developing promising carbohydrate-based therapies
for the treatment of fibrotic liver disease and cancer based on the
Company's unique understanding of galectin proteins, which are key
mediators of biologic function. Galectin seeks to leverage
extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. The Company is pursuing a
development pathway to clinical enhancement and commercialization
for its lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
Forward Looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
relate to future events or future financial performance, and use
words such as "may," "estimate," "could," "expect" and others. They
are based on management's current expectations and are subject to
factors and uncertainties that could cause actual results to differ
materially from those described in the statements. These statements
include those regarding the hope that Galectin's development
program for GR-MD-02 will lead to the first therapy for the
treatment of fatty liver disease with advanced fibrosis and/or
cirrhosis. Factors that could cause actual performance to differ
materially from those discussed in the forward-looking statements
include, among others, that Galectin may not be successful in
developing effective treatments and/or obtaining the requisite
approvals for the use of GR-MD-02 or any of its other drugs in
development. The Company's current clinical trial and any future
clinical studies may not produce positive results in a timely
fashion, if at all, and could prove time consuming and costly.
Plans regarding development, approval and marketing of any of
Galectin's drugs are subject to change at any time based on the
changing needs of the Company as determined by management and
regulatory agencies. Regardless of the results of any of its
development programs, Galectin may be unsuccessful in developing
partnerships with other companies or raising additional capital
that would allow it to complete its ongoing or subsequent
trials. Galectin has incurred operating losses since
inception, and its ability to successfully develop and market drugs
may be impacted by its ability to manage costs and finance
continuing operations. For a discussion of additional factors
impacting Galectin's business, see the Company's Annual Report on
Form 10-K for the year ended December 31, 2015, and subsequent
filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause
its views to change, management disclaims any obligation to update
forward-looking statements.
Contacts:
Jack Callicutt, Chief Financial Officer
Galectin Therapeutics, Inc.
(678) 620-3186
ir@galectintherapeutics.com
Kathy McConnell, Senior Account Executive
Gregory FCA
(610) 228-2149
kmcconnell@gregoryfca.com
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