US-based Galectin Therapeutics has started a ten-patient Phase IIa pilot trial with GR-MD-02, a complex carbohydrate drug, to treat moderate-to-severe plaque psoriasis.
The company is a developer of therapeutics that target galectin proteins to treat fibrosis and cancer.
The genesis of the pilot trial is the apparent remission of a patient with severe psoriasis who participated in the company’s Phase I trial group 4mg/kg of GR-MD-02 to treat non-alcoholic steatohepatitis (NASH).
The company stated that the patient received her fourth infusion of GR-MD-02 in May 2014, and her psoriasis remained in complete remission for 17 months, with slight scaling becoming evident on her elbows this month.
Galectin president, chief executive officer and chief medical officer Peter Traber said: "We are excited to begin this study at the Brooke Army Medical Center in San Antonio, Texas.
"We know from the scientific literature that galectin-3 is at higher levels in the skin of psoriasis patients, and that GR-MD-02 inhibits galectin-3. It would follow that GR-MD-02 could affect this disease.
"We are hopeful that patients with moderate-to-severe plaque psoriasis will show a clearing of their disease without the negative side effects associated with many of the currently available therapies.
"In addition, a successful pilot study would add to our robust therapeutic pipeline for this compound."
In this open-label Phase IIa trial, ten psoriasis patients with =10% of their skin affected and a psoriasis activity and severity index (PASI) of =12 points will be treated with 8mg/kg of GR-MD-02 every other week for a total of seven infusions.
The trial’s primary endpoint will be the PASI-75, or a 75% improvement in the severity of the disease 30 days following the final infusion.
GR-MD-02 targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis, that plays a major role in diseases that involve scaring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system.
According to the company, GR-MD-02 binds to galectin proteins and disrupts their function.
Data from the preclinical animal trials showed that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
Image: Plaque psoriasis on an arm. Photo: courtesy of en:User:Marnanel.