HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase IIb trial (NCT03372811).

“The initiation of a Phase III clinical trial for our IND, approved by the FDA, is another key milestone for the company in the final stage of our world’s first botanical new drug development following a successful Phase IIb trial for the treatment of psoriasis." – Liping Yang, CEO of HiST Pharma

The upcoming randomized, double-blind, vehicle-controlled, multicenter study aims to demonstrate the superiority of a world first-in-class naturally-occurring botanical new drug over the vehicle in treating psoriasis vulgaris in a large U.S. population, in terms of efficacy and long-term safety.

“The initiation of a Phase III clinical trial of our IND in the U.S. is another key milestone for the company in the final stage of our world’s first botanical new drug development. It is based on a successful Phase IIb trial and benefits from an earlier multicenter clinical trial of an approved new drug by the National Medical Products Administration (NMPA) in China for the treatment of psoriasis,” said Liping Yang, Chief Physician, Managing Director of PRIG, and CEO of HiST Pharma. “Our IND, TC Cream, offers a new topical option to treat psoriasis patients with breakthrough therapy targeting multiple autoimmune signaling pathways, aiming to address patients’ unmet medical needs and improve their long-term quality of life. With the clinical clearance from the FDA, we are one step closer to bringing TC to benefit millions of patients affected by this debilitating disease. We hope that TC will become the world’s first botanical drug serving as a first-line topical treatment for psoriasis and the third botanical drug ever approved for marketing by the FDA.”

HiST Pharma is planning to continue its global licensing strategy with biotech pharma partners to further leverage the product's market potential.

 

Source:businesswire.com

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