Trek Therapeutics recently secured an exclusive worldwide license from Theravance Biopharma to develop, manufacture, use, market and sell TD-6450 as a component in combination HCV products.
Under the Phase 2a clinical trial, which is being carried out in the US, Trek will evaluate faldaprevir (FDV), an HCV protease inhibitor, combined with TD-6450 and ribavirin (RBV) in patients infected with HCV genotype 4.
Theravance Biopharma discovered TD-6450, a multivalent NS5A inhibitor designed to have enhanced antiviral activity against genotype 1 resistance-associated variants (RAV) resistant to first generation NS5A inhibitors.
The inhibitor has completed phase 1 trials in both healthy volunteers and HCV patients.
Theravance Biopharma senior vice president of research and development Mathai Mammen said: "This NS5A inhibitor has shown robust antiviral activity in a Phase 1 trial in patients with HCV genotype 1, as well as preclinical potency against both wild type HCV and resistance-associated variants.
"We believe that its antiviral activity, in combination with other antivirals, may help improve cure rates and/or reduce treatment times for appropriate patients.
Trek Therapeutics chief medical officer Robert Hindes said: "If safety and efficacy are demonstrated, the goal is to initiate clinical trials in Egypt next year, where the need is enormous."