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news.Medivir has concluded patient recruitment in three Phase 3 trials evaluating TMC435 in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients.
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TMC435, an investigational CHC protease inhibitor currently in phase 3 clinical development, is a highly potent, selective and safe once-daily (q.d.) drug jointly developed by Tibotec Pharmaceuticals to treat chronic hepatitis C virus infections.
The drug is being developed both in combination with PegIFN/RBV and in combination with Direct-acting Antiviral (DAA) agents without peginterferon and with or without ribavirin (RBV).
The trials are Quest 1 and Quest 2, in treatment naive patients, and Promise in the treatment experienced relapser patient population.
In all three trials, the duration of total treatment is response guided and patients in the TMC435 arms are eligible to stop all treatment at week 24 if predefined response-guided criteria are met.
Medivir chief scientific advisor Bertil Samuelsson said it is a monumental milestone step for Medivir as a company and for TMC435 progress towards market registration.
"The completed enrollment of Phase 3 studies for TMC435 in Japan represents another key project milestone achievement," Samuelsson said.