Abbott hep C drug ABT-450/r impresses in mid-stage trial
pharmafile | November 2, 2010 | News story | Research and Development | ABT-450/r, Abbott, Abbott Laboratories, American Liver Disease congress, Enanta Pharmaceuticals, Norvir, hepatitis C
Mid-stage trial results of Abbott Laboratories’ oral hepatitis C drug ABT-450/r have impressed at the American Liver Disease congress.
The phase II data showed 91.3% of treatment-naïve patients achieved hepatitis C viral levels (HCV-RNA) of less than 25 IU/mL after four weeks of treatment with ABT-450/r and Abbott’s established antiviral Norvir
Abbott also said that after just three days treatment with ABT-450/r alone, patients had a statistically significant reduction of HCV-RNA when compared to placebo across the full dosing range.
Scott Brun, divisional VP of infectious disease development at Abbott, said: “Abbott has focused its antiviral research expertise on finding new treatment options for HCV-infected patients that could transform current therapy – by shortening the duration of treatment and increasing cure rates.
“We continue to explore the potential for use of ABT-450/r in a variety of combination regimens.”The objectives of the 48-week phase II study are to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple dose strengths of ABT-450/r in treatment-naïve adults infected with HCV genotype 1, which is the most common and difficult to treat form of the infection in the developed world.
Trial endpoints include early virologic response and rapid virologic response and it was used with a100mg dose of Abbott’s Norvir to support once-daily dosing.
Abbott is developing the antiviral drug with Massachusetts, US-based Enanta Pharmaceuticals.
Jay Luly, president and chief executive of Enanta Pharmaceuticals, said: “We are very encouraged by the three-day monotherapy and four-week rapid virologic response results for ABT-450 and we look forward to further clinical results from the programme.
“These data are an important step in our HCV programme, and for advancing our broader vision to improve patient care in this field.”
Ben Adams
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