GR-MD-02 Demonstrates Clinically Significant Effect in Patients with Severe and Refractory Atopic Dermatitis (Eczema)
March 14 2017 - 8:47AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
today announced preliminary results for severe and refractory
atopic dermatitis from a small, open label, investigator-initiated
study with GR-MD-02 that has enrolled 3 patients. There were no
serious adverse events observed. All three patients showed
clinical response as determined by reduction of the Eczema Area and
Severity Index (EASI) score at week 12 having received 6 every
other week doses, with two patients achieving a 64% and 74%
reduction in EASI, respectively, at six weeks after receiving only
3 doses of GR-MD-02 (see graph below). These findings are believed
to demonstrate a clinically significant effect of this novel
investigational drug in this patient population. More information
and commentary on these findings can be found in a simultaneously
released CEO
Perspective: http://perspectives.galectintherapeutics.com/galectin-inhibitor-therapy-effective-severe-atopic-dermatitis-eczema/.
A photo accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/254ebcff-519a-41b0-8f1a-e9c9be2b09ee
Simon A. Ritchie, M.D., FAAD, lead investigator and
staff dermatologist, San Antonio Military Health System, Fort Sam
Houston, TX, said “There is a lack of effective therapy currently
on the market for patients with severe, refractory atopic
dermatitis. As a galectin-3 inhibitor, GR-MD-02, represents a novel
mechanism for treatment in patients with severe atopic dermatitis
that have failed standard of care. The significant clinical effect
we have seen from preliminary results in this
investigator-initiated protocol is encouraging and warrants a phase
2 controlled trial with various doses and regimens to further
explore the drug’s potential.”
The small, open label, investigator-initiated
protocol treated three adult patients with severe atopic
dermatitis. All three patients had failed a number of systemic
therapies and would be classified as refractory, meaning that they
have not responded to medical treatment beyond topical steroids.
The disease severity was determined using EASI, an objective
scoring system in common use for atopic dermatitis studies.
GR-MD-02 was given intravenously at a starting dose of 8 mg/kg at
baseline and then every other week for 10 weeks (6 infusions) and
then increased to 12 mg/kg every other week for an additional 7
infusions. All three patients experienced improvement in their
atopic dermatitis, with patient 1 achieving a 64% reduction in EASI
at 24 weeks, the time of his 13th infusion. While patient 1 has
completed the full 13 infusions, patients 2 and 3 have just started
the higher dose of 12 mg/kg. It should be noted that patient 1 has
elected to remain on 24 additional weeks of therapy because of the
positive effect on his clinical symptoms.
“We are pleased by the results of this study
demonstrating the safety and clinically significant effect in
patients with severe atopic dermatitis, although because of the
potential of a placebo effect in this disease, confirmation of the
magnitude of the effect will require placebo-controlled trials,”
said Peter G. Traber, M.D., president, chief executive officer and
chief medical officer, Galectin Therapeutics. “Moreover, the
activity of GR-MD-02 in these patients compares favorably with
other drugs currently in development, and with minimal side effects
as demonstrated by nearly 3,000 doses of our compound being
administered in multiple completed and ongoing clinical trials with
no severe adverse effects attributed to the drug.”
About Atopic Dermatitis Atopic
dermatitis, commonly called eczema, is a chronic inflammatory
condition of the skin of caused by multiple factors that usually
arises in early childhood, often in infancy. While it usually
resolves by early teenage years, approximately 5-10% of patients
have the disease extend into adulthood. Classic symptoms are
itching and burning of the skin, resulting in thickening of the
skin in response to the scratching. In some adults, it can be
severe with debilitating itching, inability to sleep, and social
stigmatization due to skin damage and thickening, often on the
face.
Surveys suggest that up to 18% of the population
have atopic dermatitis, up to 37% of those people seek medical
care, and over 70% of those seeking care have mild disease that is
handled by primary care physicians. Approximately 20% with mild and
2% with severe disease are referred to specialists. The national
estimated cost of treatment is as high as $3.8 billion, as of
2012.
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 Therapeutics
Galectin Therapeutics is dedicated to developing novel
therapies to improve the lives of patients with chronic liver and
skin diseases and cancer. Galectin's lead drug (GR-MD-02) is a
carbohydrate-based drug that inhibits the galectin-3 protein which
is directly involved in multiple inflammatory, fibrotic, and
malignant diseases. The lead development program is in
non-alcoholic steatohepatitis (NASH) with cirrhosis, the most
advanced form of NASH related fibrosis. This is the most common
liver disease and one of the largest drug development opportunities
available today. Additional development programs are in treatment
of severe atopic dermatitis, moderate-to-severe plaque psoriasis,
and in combination immunotherapy for advanced melanoma and other
malignancies. Galectin seeks to leverage extensive scientific and
development expertise as well as established relationships with
external sources to achieve cost-effective and efficient
development. 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, and use words such as "may," "estimate,"
"could," "believe", "expect" and others. They are based on 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 a therapy for the treatment of atopic dermatitis,
psoriasis and other skin diseases, as well as fibrotic and
cancer. 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. 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 current trials or
further develop and/or fund further 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) 620-3186
ir@galectintherapeutics.com
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