Trek Therapeutics (TREKtx) has started a Phase IIa clinical trial of TD-6450, an NS5A inhibitor being developed to treat hepatitis C (HCV).
TREKtx recently secured a worldwide licence from Theravance Biopharma for the development, manufacturing, use, marketing and sale of TD-6450 as a component in HCV products.
Phase IIa will evaluate faldaprevir (FDV), an HCV protease inhibitor, combined with TD-6450 and ribavirin (RBV) in patients infected with HCV genotype 4.
Theravance Biopharma research and development senior vice-president Mathai Mammen said: "This NS5A inhibitor has shown robust antiviral activity in a Phase I 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.
Theravance discovered TD-6450 to have improved antiviral activity against genotype 1 resistance-associated variants (RAV) that are resistant to first-generation NS5A inhibitors.
Multivalent NS5A inhibitor TD-6450 has successfully completed Phase I trials in healthy volunteers and HCV patients.
TREKtx chief medical officer Dr 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."
TREKtx’s objective is to develop affordable and accessible medicines for treating infectious diseases and commercialise them for patients worldwide.