Medivir AB (OMX: MVIR) today announced top-line results from three pivotal phase III 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 II studies.
Final analysis of the phase III 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 III 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."
QUEST-1 (C208), QUEST-2 (C216) and PROMISE (C3007)
In the global QUEST-1 and QUEST-2 trials, 394 and 391 respectively, treatment-naïve patients with genotype 1 hepatitis C were randomized to receive either 150 mg of once-daily simeprevir for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks based upon response guided treatment criteria (simeprevir group) or pegylated interferon and ribavirin alone for 48 weeks (control group).
In the PROMISE study, 393 patients, who had previous relapse after completing HCV treatment with pegylated interferon and ribavirin, were randomized to receive either 150 mg of once-daily simeprevir for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks based on response guided treatment criteria (simeprevir group) or pegylated interferon and ribavirin alone for 48 weeks (control group).