Research done in partnership with San Antonio Military Medical Center showed an average 50% PASI reduction by end of 24-week treatment period
NORCROSS, Ga., March 06, 2017 (GLOBE NEWSWIRE) -- 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."
Psoriasis, 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.
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 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.
Jack Callicutt, Chief Financial Officer
Source: Galectin Therapeutics
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