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STD07, a single anthraquinone compound, is developed for the treatment of Inflammatory Bowel Disease (IBD) via its anti-inflammatory effect and many other receptors on the GI lumens. STD07 is originally identified from several Chinese medicinal herbs that had been used for GI disorders.
Pre-clinical studies in IBD animal models showed that STD07 was effective in improving animal IBD symptoms as compared to the vehicle control.
In safety pharmacology, short-term and long-term toxicology studies, STD07 has been shown to have sufficient safety margins to support the intended clinical trials in humans. A near-completed Phase I trial indicated the maximal tolerable dose is about 10 to 5 times of the expected clinical dose.
A non-GCP, pilot phase I/II trial in 27 patients with constipation was conducted in Taiwan to evaluate the preliminary efficacy and safety of STD07 at the dose of 20 mg OD for two weeks. STD07 showed efficacy in those patients. No adverse events were reported and all blood chemistry results were within normal ranges.
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