A significant clearing of psoriasis in first four
patients prompts the extension of treatment for an additional 12
weeks
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
announces positive interim results from an exploratory, open-label,
Phase 2a clinical trial with GR-MD-02 in patients with
moderate-to-severe plaque psoriasis. All four patients who received
12 weeks of therapy (six doses of GR-MD-02) had significant
improvement in their plaque psoriasis. Given the improvement noted,
Galectin has extended the treatment duration to 24 weeks.
This Phase 2a open-label trial is being
conducted in 10 patients with moderate-to-severe plaque psoriasis
who have ≥ 10% of their skin surface area affected and a PASI
(Psoriasis Area and Severity Index) of ≥ 12 points. The enrolled
patients are being treated with 8 mg/kg of GR-MD-02 every other
week for a total of seven infusions, with the seventh infusion
being administered on the same day the 12-week PASI is scored. The
primary efficacy assessment in this study is improvement in PASI,
as described in detail in a recent CEO Perspective.
“Each of the four patients who received six
doses of GR-MD-02 over 12 weeks of therapy reported improvement in
their symptoms related to psoriasis,” said Simon A. Richie, M.D.,
Staff Dermatologist, Chief of Phototherapy and Tele-Dermatology at
San Antonio Military Health System and Principal Investigator of
the trial. “Moreover, all four patients had significant improvement
in PASI measurements. It is uncommon for patients with
moderate-to-severe plaque psoriasis to spontaneously improve
without treatment. The drug infusions were well tolerated by
patients, and the two adverse events that were noted, one
infiltration of the intravenous catheter and one headache during
infusion, were mild and transient.”
Interim results are shown in the table
below.
Patient |
BaselinePASI Score |
After 3 Doses |
After 6 Doses |
PASI Score |
Percent improvement from baseline |
PASI Score* |
Percent improvement from baseline |
1 |
13.6 |
9.2 |
|
32 |
% |
8.1 |
|
40 |
% |
2 |
14.6 |
12.5 |
|
14 |
% |
7.9 |
|
46 |
% |
3 |
12.3 |
9.1 |
|
26 |
% |
10.6** |
|
14 |
% |
4 |
12.8 |
7.2 |
|
44 |
% |
4.3 |
|
66 |
% |
* PASI performed on same day as 7th
infusion |
** PASI performed 1 week following
7th infusion; patient taken off systemic therapy for psoriasis one
month prior to starting therapy |
|
“These interim results on four patients in this
exploratory clinical trial demonstrate a potentially important
clinical effect of GR-MD-02 in clearing moderate-to-severe plaque
psoriasis,” said Peter G. Traber, M.D., Galectin’s president, chief
executive officer and chief medical officer. “While these patients
were not evaluated for fatty liver disease, these findings may have
implications for activity in our main therapeutic program targeting
NASH, a disease where there is a high incidence of psoriasis and
increased galectin-3 in the skin. We are excited to extend this
trial to better determine the full potential of GR-MD-02 as a
treatment for moderate-to-severe psoriasis.”
The link, if any, between non-alcoholic
steatohepatitis (NASH) and psoriasis is not completely
understood. However, patients with psoriasis have more than a
two-fold higher incidence of NASH, the severity of which tends to
correlate with the severity of liver fibrosis and galectin-3 is
increased in psoriatic skin. The genesis of this Phase 2a psoriasis
treatment study was a 17 month remission in a NASH patient with
severe psoriasis who participated in the Company’s Phase 1 study
cohort of 4 mg/kg of GR-MD-02 for the treatment of NASH (see CEO
Perspective).
“This Phase 2a clinical trial will be extended
so that all patients, including the four who have already completed
treatment, will receive a total of 13 drug infusions,” added Dr.
Richie. “The one patient among the initial four with the least
objective response in PASI was on a systemic retinoid therapy
(acitretin) which was stopped one month before entering this study.
Stopping this drug can lead to a long-term rebound effect, which
may have contributed to the lower treatment response. Doubling the
duration of therapy, and continued enrollment to the full 10
patients, will help us to evaluate the full therapeutic potential
of GR-MD-02 in psoriasis.”
The announced results are interim in that the
originally scheduled 12 weeks of data has been obtained from only
four of the ten patients who will participate in the trial.
It is further interim in that the positive information obtained to
this point has led to the trial being extended for all 10 study
subjects in the trial.
Conference Call and Webcast
Galectin Therapeutics management will host a conference call at
9:00 a.m. Eastern time on May 17, 2016 to discuss this press
release.
To access the conference call, U.S.-based listeners should dial
866-634-2258 and international listeners should dial 330-863-3454.
All listeners should provide the following passcode: 10667177.
Individuals interested in listening to the live conference
call via the Internet may do so by logging on to the Company’s
website at www.galectintherapeutics.com.
Following the conclusion of the conference call,
a replay will be available through May 23, 2016 and can be accessed
by dialing (855) 859-2056 from within the U.S. or (404) 537-3406
from outside the U.S. All listeners should provide passcode
10667177. The webcast will be available on the Company’s website at
www.galectintherapeutics.com for 90 days.
About PsoriasisPsoriasis, which
manifests most often as plaque psoriasis, is a chronic, relapsing,
inflammatory skin disorder. Although plaque psoriasis is rarely
life threatening, it often is intractable to treatment. According
to the International Federation of Psoriasis Associations, about 3%
of the world’s population has some form of psoriasis. In the U.S.
there are about 150,000 new cases every year, and psoriasis affects
about 2% of the U. S. population, according to the Cleveland
Clinic.
About GR-MD-02GR-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 Galectin
TherapeuticsGalectin 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 StatementsThis
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 cirrhosis and/or an additional therapy for the
treatment of moderate to severe psoriasis and that positive results
in treating psoriasis may have implications for the treatment of
NASH. Factors that could cause actual performance to differ
materially from those discussed in the forward-looking statements
include, among others, that interim results in only four patients
may not be indicative of the results when all 10 patients are
treated in the Phase 2a trial, and even if the Phase 2a open label
trial when completed reports positive results, those results may
not be repeated in larger blinded trials that are required for
licensing. Further, 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, when completed,
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. 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 further develop and/or fund any
studies or 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(678) 620-3186ir@galectintherapeutics.com
LHAKim Golodetz(212)
838-3777kgolodetz@lhai.com
Galectin Therapeutics and its associated logo is
a registered trademark of Galectin Therapeutics Inc.
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