Galectin Therapeutics (GALT) Announces Results from GR-MD-02 Phase 2a; Won't Continue Testing in Psoriasis

August 25, 2016 7:55 AM EDT

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Galectin Therapeutics (Nasdaq: GALT) announces interim results from an exploratory, open-label, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis.

In May, the company announced significant improvement in PASI (Psoriasis Area and Severity Index) scores at the 12-week mark for all four patients in the study (7 infusions of 8 mg/kg every other week). These results prompted an extension of treatment for an additional 12 weeks at the same dose and dosing interval (13 total infusions). Four patients have now completed 24 weeks of therapy with GR-MD-02, and a fifth patient has completed 12 weeks. Despite the extension of treatment, the original four patients have experienced minimal additional improvement in their psoriasis beyond that first reported in May.

“We are pleased to report that there is clinically meaningful activity of GR-MD-02 for the treatment of moderate to severe psoriasis,” said Peter G. Traber, M.D., Galectin’s president, chief executive officer and chief medical officer. “Moreover, this activity in a human disease, strongly associated with NASH and increased galectin-3 expression, suggests that GR-MD-02 may also have activity in NASH, which remains the company’s primary target.

“While the improvement among the patients is significant, we have to consider the extent of improvement in the context of biological agents for psoriasis currently on the market or in development. The primary endpoint for these existing agents is a 75% improvement in PASI, and none of our patients reached that level of improvement at the dose level and duration administered in the study. There are potential advantages which GR-MD-02 might have over biological agents, such as safety and cost, and the current safety profile of GR-MD-02 does support the possibility of studying higher doses or a more frequent dosing regimen for psoriasis. However, without much more study, these potential advantages remain untested.”

Galectin Therapeutics conducted this small psoriasis study because of an unexpected positive effect on the psoriasis of a NASH patient in the Company’s Phase 1 trial in liver disease. Given the Company’s focus on the phase 2 program in NASH with advanced fibrosis and cirrhosis, additional studies to develop GR-MD-02 as a psoriasis treatment will not occur at this time. The Company may later conduct additional studies in psoriasis either directly or through a partner who may wish to take this forward.

“The results of the psoriasis trial confirm GR-MD-02 is active in a human disease,” concluded Traber. “The Company continues to pursue the application of GR-MD-02 for the treatment of NASH with liver fibrosis and cirrhosis which has always been the primary focus of our business.”

Results of the 24-week psoriasis trial are shown in the table below.



PASI Score

After 7 Doses

After 13 Doses

PASI Score



from baseline

PASI Score



from baseline


13.6 8.1 40% 7.4 46%


14.6 7.9 46% 6.0 59%


12.3 10.6 14% 9.0 27%


12.8 4.3 66% 5.1 60%


19.1 12.7 34% NA NA

NA: Data not currently available

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