Psoriasis Research Institute of Guangzhou (PRIG), a subsidiary of iST Pharma, has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III trial of its investigational new drug (IND), TC Cream, for the treatment of psoriasis vulgaris. The upcoming trial in the US follows the completion of a Phase IIb study. The randomised, double-blind, vehicle-controlled, multicenter trial aims to demonstrate the superior efficacy and long-term safety of TC Cream compared to the vehicle in patients with psoriasis vulgaris. TC Cream is the world’s first botanical small-molecule drug specifically developed for psoriasis vulgaris. The initiation of the Phase III trial marks a significant milestone for HiST Pharma and PRIG, bringing them closer to providing a new topical treatment option that targets multiple autoimmune signalling pathways and addresses the unmet medical needs of psoriasis patients, potentially improving their long-term quality of life.
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