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news.Sucampo Pharma, a wholly-owned subsidiary of Sucampo Pharmaceuticals Inc, has initiated dosing in a first-in-human clinical safety study of a proprietary prostone, SPL-017, as a potential treatment for peripheral arterial disease.
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The randomized, double-blind, placebo-controlled, single-center, single ascending dose study will evaluate the safety and pharmacokinetic profile of SPL-017. A total of 74 healthy adult male subjects will be enrolled in eight dose groups, receiving intravenous doses of SPL-017 ranging from 3mcg to 360mcg.
SPL-017 is another pipeline compound that Sucampo Pharmaceuticals has entered into human clinical studies. Sucampo continues to develop cobiprostone (SPI-8811) for treatment of non-steroidal anti-inflammatory drug induced ulcers. Lubiprostone, trade name Amitiza, approved in the US as a treatment for chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women, is currently under development for opioid-induced bowel dysfunction.
Gayle Dolecek, senior vice president of R&D at Sucampo, said: “We believe that SPL-017 has potential for treatment of a variety of vascular diseases, including peripheral arterial disease. In preclinical animal studies, intravenously administered SPL-017 improved peripheral circulation without significantly affecting systemic blood pressure. In addition, in other animal studies, SPL-017 had no effect on platelet aggregation and protected endothelial barrier function.”