US-based biotechnology firm Cocrystal Pharma has signed a clinical trial agreement with Humanity & Health Research Centre in Hong Kong to conduct a Phase IIa clinical trial of its hepatitis C drug candidate CC-31244 in the country.
Under the agreement, Humanity & Health Research Centre will sponsor and perform the investigator-initiated trial, while CC-31244 will be supplied by Cocrystal Pharma.
Developed using the company’s structure-based drug discovery technology, CC-31244 is an oral, potent, broad-spectrum replication inhibitor called non-nucleoside inhibitor (NNI). It can act against HCV genotypes 1-6 and is said to be an ultra-short treatment.
Humanity and Health Medical Centre chairman George Lau said: “There remains a huge unmet need for shorter, safe and effective treatment options for treating hepatitis C in the Asian population.
“Clinical data on CC-31244 has been very compelling and has demonstrated promise in the potential to provide an ultra-short therapy to patients.”
The open-label Phase IIa trial will investigate the safety, tolerability and preliminary efficacy of CC-31244 in conjunction with sofosbuvir and daclatasvir, with or without a protease inhibitor.
Expected to be initiated in the fourth quarter of this year, the trial will enrol 16 patients with hepatitis C infection.
Cocrystal Pharma vice-chairman and CEO Gary Wilcox said: “We are grateful to the Humanity & Health Research Centre for sponsoring and conducting the study and look forward to further understanding the potential to change the treatment paradigm for patients living with HCV by providing an ultra-short therapy to enhance the existing hepatitis C combination therapies.”
According to the World Health Organization (WHO), an estimated 71 million people are chronically infected with the hepatitis C virus globally, leading to about 399,000 deaths each year.
In Asia, the prevalence of hepatitis C has been estimated to be more than 1%.