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news.Genzyme said that its polymer therapy for Clostridium difficile associated diarrhea missed its trial goal of non-inferiority to the standard treatment for the infection.
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Top-line data from the first of two phase III clinical studies to assess the safety and efficacy of tolevamer liquid, a polymer therapy for patients with Clostridium difficile associated diarrhea (CDAD), showed that the drug did not meet its primary endpoint of non-inferiority to the standard prescribed oral dose of the antibiotic vancomycin. The second phase III study of tolevamer liquid is fully enrolled and results are expected later this year.
This result contrasts with the findings from Genzyme’s earlier phase II study of a solid oral dosage formulation of tolevamer that met its primary endpoint of non-inferiority compared to vancomycin, the company said.
Consistent with recent published studies, high rates of CDAD recurrences were observed in patients treated with either vancomycin or metronidazole. High CDAD recurrence rates were not observed in patients treated with tolevamer liquid. Tolevamer liquid was generally well tolerated with no unanticipated safety concerns.
“These are disappointing results that alter our expectations about the potential for commercializing tolevamer in the near future,” stated Henri Termeer, chairman and CEO of Genzyme. “The results of our second phase III study will be available later this year and will help us determine what contribution tolevamer might be able to make in addressing this serious unmet medical need.”
C. difficile has become one of the most significant infection control concerns in healthcare today. Physicians worldwide are confronting a worsening epidemic, with an alarming rise in the incidence of disease, higher numbers of patients with complications and more frequent failures of standard antibiotic therapy.
Tolevamer is designed to bind and neutralize the toxins released by C. difficile that damage the intestine. A non-antibiotic approach has the potential to treat CDAD and reduce the number of disease recurrences, resulting in improved quality of life for the patient and significant savings to the healthcare system.