Bezlotoxumab: Phase III data

The double-blind, international Phase III MODIFY I trial in 1,452 patients receiving standard of care (SOC) antibiotics for CDI showed that a single IV infusion of 10 mg/kg bezlotoxumab alone and in combination with 10 mg/kg actoxumab each met the primary endpoint of a lower rate of CDI recurrence at week 12 vs. placebo (17.4% and 15.9%, respectively, vs. 27.6%, p=0.0003 and p<0.0001). Patients received SOC plus single IV infusions of placebo, bezlotoxumab alone, actoxumab alone or a combination of the 2 mAbs. Merck said a single IV infusion of 10 mg/kg actoxumab ( MK-3415), a human mAb targeting Clostridium difficile toxin A (TcdA), provided no benefit in the prevention of CDI recurrence vs. placebo. The bezlotoxumab arms also led to lower rates of CDI recurrence vs. placebo in the pre-specified subgroups of patients with any prior episode(s) of CDI within the previous 6 months, patients infected with the BI/NAP1/027 strain, patients with severe CDI, patients ages >=65 and patients with compromised immunity. The most common adverse reactions reported through 4 weeks after infusion were nausea, diarrhea and pyrexia. Data were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection joint meeting in San Diego. ...