Date: 2015-08-03
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Alios Biopharma, a J&J company (USA - NJ) Achillion Pharmaceuticals (USA - CT)
Product: simeprevir, odalasvir (ACH-3102) and AL-335
Action mechanism: direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS5B) inhibitor Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir. Odalasvir (also known as ACH-3102) is a structurally distinct, second-generation NS5A inhibitor, which achieved 100% SVR12 in a Phase 2 study of genotype 1 HCV patients treated for 6-weeks with ACH-3102+sofosbuvir. AL-335 is a nucleotide-based HCV polymerase inhibitor.
Disease: chronic hepatitis C
Therapeutic area: Infectious diseases
Country: France
Trial details: This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and Simeprevir on AL-335 pharmacokinetics in healthy volunteers. (NCT02512562)
Latest news: * On August 3, 2015, Achillion Pharmaceuticals announced that Alios Biopharma, part of the Janssen Pharmaceutical Companies (Janssen) has initiated a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102) on the pharmacokinetics of AL-335 in healthy volunteers. This phase I study is an open-label, two-group study of simeprevir and odalasvir, a HCV NS5A inhibitor, on the pharmacokinetics of AL-335, a nucleotide-based HCV polymerase inhibitor. The primary objective of the study is to investigate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 when administered in combination to healthy volunteers. As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.
