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HiST Pharma Announces U.S. FDA Approval to Initiate Phase III Clinical Study With TC Cream – World’s First Botanical Small-Molecule Drug That Treats Psoriasis Vulgaris

May 17, 2023 Off By BusinessWire

GUANGZHOU, China–(BUSINESS WIRE)–HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) 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 II^b 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 II^b 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 II^b 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.

About PRIG

Psoriasis Research Institute of Guangzhou (PRIG), a wholly-owned research institute of HiST Pharma, was founded in 2008 in Guangzhou, China. PRIG has been developing TC, a botanical-based small-molecule drug since 2008. Compared to the existing therapeutic drugs, TC has a novel and different mechanism to treat psoriasis vulgaris and clinical treatment characteristics of rapid onset, good efficacy, and minimal side effects.

In its Phase II^b clinical study in the U.S., NCT03372811, TC demonstrated its superior efficacy over the vehicle under an 8-week regimen, and an excellent safety and tolerability profile owning to its multi-target and multi-system immunomodulation property that simultaneously promotes anti-inflammatory and blocks pro-inflammatory mediators. PRIG is currently preparing to launch the Phase III study in the U.S.

HiST Pharma