HiST Pharma to Start Phase III Clinical Study to Treat Psoriasis Vulgaris
HiST Pharma, along with its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG), made an announcement today regarding the approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) TC Cream.
This approval allows for the initiation of a Phase III clinical study, conducted across multiple centers in the United States, aimed at treating patients with psoriasis vulgaris.
The decision to proceed with this study comes after the successful completion of a Phase IIb trial (NCT03372811).
In the upcoming randomized, double-blind, vehicle-controlled, multicenter study, HiST Pharma aims to establish the superiority of its world-first naturally-occurring botanical new drug compared to the vehicle in treating psoriasis vulgaris.
The study will be conducted on a large population in the United States, with the primary objective being to demonstrate the drug's efficacy and long-term safety.
Furthermore, HiST Pharma intends to pursue its global licensing strategy by collaborating with biotech pharma partners to maximize the market potential of this product.
