Medivir AB announced top-line results from three Phase 3 trials examining the one pill, once-daily, investigational protease inhibitor, simeprevir (TMC435), administered with pegylated interferon and ribavirin.
Results from the QUEST-1 and QUEST-2 trials found that 80% and 81% of treatment-naive patients with chronic genotype 1 hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR12). Results from the PROMISE trial found that 79% of prior relapsed patients treated with simeprevir achieved SVR12. All three studies utilized response-guided treatment (RGT) criteria and 85%, 91% and 93 % of the patients, respectively, were eligible to stop all treatments after 24 weeks.
The overall safety, tolerability and efficacy results from these studies were consistent with those previously obtained in Phase 2 studies.
Final analysis of the Phase 3 trials is ongoing and the full data set from these studies will be submitted for presentation at future scientific conferences.
"We are extremely happy about the data from these Phase 3 studies, which robustly demonstrate high cure rates in both treatment-experienced, so called relapsers, and treatment-naïve patient groups, both including patients with severe liver disease. Together with the very good safety profile and the fact that a large proportion of the patients were eligible to end all treatments in a shorter time frame as compared to current standard of care, should provide new hope for large patient groups with this disease”, said Charlotte Edenius, EVP of Research and Development, Medivir AB. “We look forward to seeking regulatory approvals to bring simeprevir forward to help treat people living with chronic hepatitis C."
Date: December 20, 2012
Source: Medivir AB