HiST Pharma subsidiary Psoriasis Research Institute of Guangzhou (PRIG) has secured approval for its investigational new drug (IND), TC Cream, from the US Food and Drug Administration (FDA) to commence a Phase III trial in patients with psoriasis vulgaris.
The US-based trial is set for launch following a Phase IIb study that was previously concluded.
The proposed randomised, double-blind, vehicle-controlled, multicentre trial has been designed to show the superiority of TC Cream in terms of efficacy and long-term safety over the vehicle to treat patients with psoriasis vulgaris in the US.
TC Cream represents the world’s first botanical small-molecule drug for treating psoriasis vulgaris.
HiST Pharma CEO and PRIG chief physician and managing director Liping Yang said: “The initiation of a Phase III clinical trial of our IND in the US 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.
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“Our TC Cream offers a new topical option to treat psoriasis patients with breakthrough therapy targeting multiple autoimmune signalling 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.”