Findings published in Open Forum Infectious Diseases indicated that surotomycin did not show superiority or noninferiority to vancomycin for treating Clostridium difficile infection.
“Clostridium difficile infection [CDI] remains a leading cause of hospital-acquired diarrhea,” Vicente Boix, MD, PhD, of the unit of infectious diseases, Hospital General Universitario de Alicante, Alicante, Spain, and colleagues wrote. “Surotomycin is a novel cyclic lipopeptide in development for the treatment of CDI. In phase 2 clinical trials, CDI cure rates were similar for surotomycin 125 mg twice daily, 250 mg twice daily and oral vancomycin 125 mg four times daily.”
Boix and colleagues conducted a randomized phase 3 trial to demonstrate the efficacy and safety of twice-daily surotomycin compared with four-times daily vancomycin in patients with confirmed CDI (n = 570) from July 28, 2012 to March 20, 2015. The study included adults from 115 sites in North America, Europe and the Middle East. The primary outcomes were clinical response and safety. Secondary outcomes included response after 30 to 40 days of follow-up and time to diarrhea resolution. Two hundred-ninety patients were randomized to surotomycin and 280 to vancomycin.
Surotomycin produced a clinical cure rate of 79% at the end of treatment, compared with 83.6% for vancomycin (95% CI, -11 to 1.9), the researchers reported. Although Boix and colleagues wrote that both drugs were well tolerated, surotomycin had a sustained clinical response of 60.6% at the end of the trial, compared with 61.4% for vancomycin (95% CI, -8.8 to 7.1).
“Given the burden of CDI and its recurrence, clinical development of new CDI therapeutics remains an urgent unmet medical need,” the researchers wrote. “The data from this phase 3 trial, which was conducted to assess the safety and efficacy of surotomycin relative to vancomycin, demonstrated that surotomycin did not meet the primary efficacy endpoint of noninferiority compared with vancomycin; nor did it meet the key secondary efficacy endpoints of clinical response over time and sustained clinical response superiority over vancomycin.” – by Andy Polhamus
Disclosure: Boix reports consulting and speaking fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck Sharpe & Dohme and ViiV Healthcare. Please see the full study for a complete list of all other researchers’ relevant financial disclosures.