FDA has approved Zealand Pharma's Investigative New Drug application for ZP1846 to be administered in humans
ZP1846 developed for the prevention and treatment of severe diarrhoea induced by chemotherapy
Zealand Pharma advances ZP1846 into Phase I clinical trials. ZP1846, a peptide which incorporates Zealand's proprietary SIP technology, is developed as a therapy for the prevention and treatment of chemotherapy-induced diarrhoea, a debilitating adverse reaction affecting patients undergoing treatment with many anti-cancer therapies.
The Phase I study will be a double-blind, placebo controlled, randomized, escalating intravenous single dose safety and tolerability study in healthy volunteers and takes place in the United States.
Zealand's pre-clinical studies have demonstrated that ZP1846 inhibits chemotherapy-induced injury in the small intestine, and consequently, it also reduces the incidence of chemotherapy-induced diarrhoea. It is anticipated that the use of ZP1846 in patients undergoing chemotherapy may ameliorate the destructive effects of the chemotherapy on the small intestine and reduce the severity of diarrhoea.
Eva Steiness , Chief Executive Officer, commented: "Advancing ZP1846 into clinical trials further strengthens our development pipeline. Zealand Pharma has applied its knowledge of peptide optimization and its proprietary SIP technology to develop a series of novel peptides that specifically enhance the growth and function of the lining of the small intestine."
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