Two Chinese companies Huya Bioscience International and Chipscreen Biosciences have initiated phase I clinical trials of their investigational cancer compound, Chidamide (CS055)/ HBI-8000 in China. Huya holds exclusive rights to the compound (HBI-8000) worldwide outside of China, while Chipscreen maintains rights in China. The phase I clinical trial is designed to assess the safety, tolerability and pharmacokinetics of the compound.
Huya will assist Chipscreen with development of Chidamide in China. Huya also plans to file an Investigational New Drug application and commence clinical trials with HBI-8000 in the United States and Europe.
Dr Mireille Gingras, HUYA's President and Chief Executive Officer, said, “The initiation of phase I trials is a significant achievement for us. It represents both an important development milestone for this promising cancer compound and illustrates the benefits of Chinese and American Biotech companies working together to efficiently carry out drug development. This important step will expedite the clinical development process of HBI-8000 in the US and Europe.”
Chidamide/HBI-8000 is an orally bioavailable histone deacetylase (HDAC) inhibitor derived from the benzamide class. Histone deacetylase inhibitors are a new class of cancer drugs that induce selective regulation of gene expression in cancer cells. Chidamide/HBI-8000 has exhibited preclinical efficacy and pharmacokinetic properties that may translate into a superior clinical profile over other HDAC inhibitors currently in development or being marketed.