Results showed that following 12 weeks of treatment with the antibody and a single infusion of bezlotoxumab, which was designed to block the ability of a toxin to attach itself to a cell, the risk of C. difficle recurrence was decreased by 15%. Instead, bezlotoxumab is a “selective, fully-human, monoclonal antibody created to neutralize C. difficile toxin B”. It was developed by the University of Massachusetts Medical School’s MassBiologics Laboratory and Medarex (which is now under Bristol-Myers Squibb).
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The company, on the basis of results, is looking forward to submit new drug applications requesting for regulatory approval of the monoclonal antibody, known as bezlotoxumab, in the United States, the European Union and Canada in 2015. In the U.S.in 2011, ~500K C. diff infections led to ~29K deaths.
“Recurrence is a major challenge with C. difficile infection, and novel approaches are needed to help prevent the cycle of C. difficile recurrence”, said Dr. Dale Gerding, professor of medicine, Loyola University Chicago Stritch School of Medicine, Maywood, Ill., and a lead investigator for the studies. Merck said that they completed 2 Phase 3 studies, which were presented at Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and global Congress of Chemotherapy and Infection (ICC) joint medical meeting in San Diego.
Merck announced that actoxumab was stopped for safety and efficacy reasons after the interim analysis.
Where bezlotoxumab or bezotoxumab plus actoxumab was taken, infection recurrence was significantly lower compared with the placebo.
The double-blind studies were labeled as MODIFY I and MODIFY II.
Even in relatively less severe infections, time is much more of the essence than it is for cancer patients. The recurrence among patients with placebo was 25%. These side effects were seen in both phases of the study, the patients in treatment and placebo arms of the trial. It was interesting to note that treatment with a bezlotoxumab and actoxumab combination did not show enhanced efficacy compared with solo bezlotoxumab treatment. The tricky thing about the cure of C.difficile is that it is cured by using anti biotic which also wipe out the good bacteria from the body which keeps the C.difficile under control. People with compromised immune systems particularly those with underlying disease are at risk of developing the infection.
According to the CDC, C. difficile is a growing problem in health care facilities and nursing homes across the U.S. It is one of the most common hospital-acquired infections, and about 500,000 US patients contract the disease every year. Eight out of 10 C. difficile-related deaths occurred in patients at least 65 years of age.
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Therefore, bezlotoxumab alone was selected for the marketing authorization application.
