Galectin’s GR-MD-02 Demonstrates Efficacy in Patients with Moderate to Severe Plaque Psoriasis
March 06 2017 - 8:30AM
Research done in partnership with San Antonio
Military Medical Center showed an average 50% PASI reduction by end
of 24-week treatment period
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
today announced results from an exploratory, Phase 2a clinical
trial with GR-MD-02 in patients with moderate-to-severe plaque
psoriasis. Data to be presented at Maui Derm for Dermatologists on
March 20 to March 23, 2017 in Maui, Hawaii, showed no serious
adverse events and achieved an average PASI (Psoriasis Area and
Severity Index) reduction of over 50% in all patients that
participated in the 24-week trial, further demonstrating the safety
and efficacy of this novel investigational drug in this patient
population. Simon A. Ritchie, M.D., FAAD, lead investigator and
staff dermatologist, San Antonio Military Health System, Fort Sam
Houston, TX, said, “As a galectin-3 inhibitor and a member of the
lectin family, GR-MD-02 is an investigational drug that has
historically proven to be safe and potentially effective in
modulating inflammatory response in multiple patient populations
with related diseases such as fatty liver disease, atopic
dermatitis, and now psoriasis. What is most exciting about findings
from this trial is that one patient exceeded the primary endpoint
achieving an 80% improvement in PASI. Due to the safety
profile of GR-MD-02, raising the dose in future trials may provide
further reductions in PASI.”
The exploratory, open-label, Phase 2a trial enrolled five adult
patients with moderate-to-severe plaque psoriasis (PASI ≥ 12 and
BSA ≥ 10%) to undergo infusions of 8 mg/kg of GR-MD-02 every other
week for 24 weeks (13 infusions total). The primary endpoint of the
trial was a reduction in PASI score of 75% (PASI-75) with secondary
endpoints measuring adverse events and achieving PASI-50. One
patient exceeded the primary endpoint with an 80% reduction in PASI
30 days after their last infusion, while the other four patients
reached PASI-50 by their 10th infusion. All five patients completed
the treatment phase of the study with no serious adverse
events.
“We are pleased by the results of our 24-week psoriasis trial
demonstrating the safety and efficacy of GR-MD-02 in patients with
moderate to severe plaque psoriasis,” said Peter G. Traber, M.D.,
president, chief executive officer and chief medical officer,
Galectin Therapeutics. “Moreover, the activity of GR-MD-02 in
a human disease strongly associated with non-alcoholic
steatohepatitis (NASH) and increased galectin-3 expression suggests
that our lead compound may also show significant activity in NASH,
which remains the company’s primary target.”
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 refractory 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.
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
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