shares slumped some 5% Friday on news that the first of two phase III clinical studies for tolevamer, an investigational treatment for bacteria-related diarrhea, didn't meet its primary endpoint.
The study compared tolevamer liquid -- a non-antibiotic treatment for patients with Clositridium difficiel associated with diarrhea (CDAD) -- to the standard prescribed oral dose of vancomycin, an antibiotic. The data don't jibe with results from an earlier phase II study, which showed a solid oral dosage of tolevamer did show non-inferiority to vancomycin.
The Cambridge, Mass.-based biotechnology company said that high rates of CDAD recurrences appeared in patients treated with vancomycin or metroidazole but not in those treated with the tolevamar liquid. The investigative treatment was well-tolerated with no unanticipated safety concerns, according to the company.
"These are disappointing results that alter our expectations about the potential for commercializing tolevamer in the near future," Chief Executive Henri Termeer said. "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."
Genzyme shares were down $3.42 at $61.45 in recent trading Friday.