SYN-004 Shows Positive Results for Preventing C. difficile, Antibiotic-associated Diarrhea

Issue: July 2016

The second phase 2a open-label clinical trial of SYN-004, an investigational therapy for preventing Clostridium difficile infection and antibiotic-associated diarrhea by protecting the gut microbiome from side effects of certain IV beta-lactam antibiotics, showed positive results for the drug candidate, according to a press release.

Researchers evaluated 14 participants to determine if 150 mg of SYN-004 (Synthetic Biologics) degrades IV ceftriaxone given alone or with the proton pump inhibitor esomeprazole. Consistent with previous results, in both scenarios the agent degraded residual ceftriaxone to near or below detectable levels in the intestinal chyme of healthy individuals with functioning ileostomies. Further, study participants had similar plasma levels of ceftriaxone whether an oral PPI was present or not, and the dose was well tolerated.

“These topline data support the hypothesis that SYN-004 has the capacity to degrade residual IV ceftriaxone, in the presence of a PPI, thereby preserving the balance of the gut microbiome with the intent to prevent CDI, AAD and the emergence of antibiotic-resistant organisms, without affecting the antibiotic level in the bloodstream necessary for the treatment of primary infection,” Jeffrey Riley, president and CEO of Synthetic Biologics, said in the press release. “Our phase 2b proof-of-concept, randomized, placebo-controlled clinical trial has enrolled over 210 patients to evaluate the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower respiratory tract infection and receiving IV ceftriaxone. An interim analysis of blinded data performed by an independent data monitoring committee is expected in summer of 2016.”

Two related poster presentations will be revealed at the American Society for Microbiology Microbe 2016 meeting in June, according to the press release.

Disclosure : Riley is employed by Synthetic Biologics.