Date: 2016-06-21
Type of
information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Trek Therapeutics (USA - MA)
Product: TD-6450 and faldaprevir
Action
mechanism:
- direct-acting antiviral agent/NS5A inhibitor/protease inhibitor. TD-6450 is a multivalent NS5A inhibitor designed to have improved antiviral activity against genotype 1 resistance-associated variants (RAV) resistant to first generation NS5A inhibitors. TD-6450 has successfully completed Phase 1 studies in both healthy volunteers and HCV patients. Theravance Biopharma recently granted TREKtx an exclusive worldwide license for the development, manufacturing, use, marketing and sale of TD-6450 as a component in combination HCV products. Other terms of the transaction have not been disclosed.
- Faldaprevir is a protease inhibitor that TREKtx acquired from Boehringer Ingelheim. This compound has completed Phase 3 studies in combination with pegylated interferon and ribavirine.
Disease: hepatitis C
Therapeutic
area: Infectious diseases
Country: New Zealand, USA
Trial
details:
Latest
news:
- • On June 21, 2016, Trek Therapeutics has initiated a Phase 2a study evaluating TD-6450 plus faldaprevir with and without ribavirin in patients with genotype 1b (GT 1b) HCV infection in New Zealand and the United States. The GT 1b study was initiated following TREKtx analysis of interim results from a Phase 2a study evaluating faldaprevir plus TD-6450 and ribavirin in patients with HCV GT 4. In that 16-patient study, all patients achieved HCV RNA <15 IU/mL by treatment Week 3, and all patients with post-treatment data (10/16) have achieved a sustained viral response 4 weeks after the end of treatment (SRV4). Of the 5 patients who have completed post-treatment follow-up, all have SVR12. Six patients still on treatment have maintained HCV RNA <15 IU/mL.
Is
general: Yes
