J&J hepatitis C drug begins phase III trials
pharmafile | February 23, 2011 | News story | Research and Development | J&J, JJ, Johnson and Johnson, TMC435, Tibotec, hepatitis, hepatitis C
Johnson & Johnson has begun late stage trials of hepatitis C drug TMC435 as a first line treatment for the virus.
TMC435 will be investigated in around 1,200 treatment-naïve patients with chronic genotype 1 hepatitis C virus (HCV).
The trials will compare the efficacy, safety and tolerability of TMC435 given as a single oral tablet once daily for 12 weeks versus placebo.
In addition to this, each patient also will be treated with a background combination regimen of Roche’s Pegasys (peginterferon) and Copegus (ribavirin).
Roche’s drugs have become standard treatment for HCV, but only 40-50% of patients see the virus suppressed to levels where they are considered to be cured.
Phase II trial results released in April 2009 showed that TMC435 demonstrated potent antiviral activity and was generally safe and well tolerated as a first line treatment.
The trials will be undertaken by Ireland, Cork-based Tibotec, a subsidiary of the US healthcare giant that specialises in anti-viral therapies.
Brian Woodfall, VP of global clinical development at Tibotec, said: “The initiation of the TMC435 phase III clinical trial programme reinforces our commitment to develop innovative new treatment options that may decrease the duration of treatment for patients with chronic hepatitis C infection.”
J&J is looking to gain market share in this area and its subsidiary Janssen has its own oral hepatitis C drug telaprevir under review by the EMA.
If successful it will compete with MSD’s boceprevir, which gained fast track reviews from both the FDA and the EMA last month after the regulators decided it marked a major advance in treatment.
Ben Adams
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