Inhibitex Drug Shows Positive Results
Monday May 9, 2:21 pm ET
Inhibitex Bloodstream Infection Drug Aurexis Shows Favorable Results in Clinical Trial
ATLANTA (AP) -- Biopharmaceutical company Inhibitex Inc. said Monday that data from a mid-stage trial showed that patients with life-threatening staph infections had a better survival rate when treated with blood infection drug Aurexis as well as antibiotics, rather than using antibiotics alone.
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The Phase II, 60-patient study demonstrated that patients with serious Staphylococcus aureus infections had lower mortality and relapse rates, as well as fewer complications when treated with Aurexis combination therapy.
The company said that there was only one death and one relapse of infection in the Aurexis plus antibiotics group, compared with four deaths in the antibiotics-only group.
Inhibitex said it plans to begin a follow-on Phase II trial based on the trial data.
The company said the study uncovered two serious adverse events possibly related to Aurexis, but an independent data safety monitoring board found no serious safety issues with the treatment.
Inhibitex also noted that patients in the Aurexis group stayed an average of three days in intensive care compared with seven days in the antibiotics-only group, and that no patients in the Aurexis group saw their infection progress, compared with four patients in the antibiotics-only group.
While not an endpoint of the study, Inhibitex also reported that nine patients on antibiotics alone experienced a candida infection, or yeast infection, during the trial compared with three patients in the Aurexis group who contracted the additional infection.
"The top-line data is positive and provides the information we need to move forward and design a larger, well-powered Phase II clinical trial for Aurexis in S. aureus bloodstream infections," said William D. Johnston, chief executive and president, in a statement.
"We believe reducing mortality and the progression of sepsis in patients with these serious infections are meaningful clinical endpoints, and that decreasing the number of days these patients spend in the ICU can provide a significant pharmacoeconomic benefit to our hospitals and health-care system," Johnston continued.
Inhibitex shares fell 4 cents to $6.96 in afternoon trading on the Nasdaq.
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