Fecal-based drug failed in clinical trials

Oleg Lischuk, N+1

The American company Seres Therapeutics presented interim results of clinical trials of the experimental drug SER-109, made on the basis of human feces (Seres Therapeutics Announces Interim Results from SER-109 Phase 2 ECOSPOR Study in Multiply Recurrent Clostridium difficile Infection). The drug proved ineffective in recurrent intestinal infection caused by the bacterium Clostridium difficile.

SER-109 is a capsule with intestinal bacteria spores taken from people with a healthy gut microbiome. Unlike whole fecal preparations, it does not contain living microorganisms. In preclinical and first phase clinical trials, data were obtained on its effectiveness in infection caused by C.difficile (the drug helped 29 out of 30 participants).

89 patients with three or more relapses of the disease participated in the second phase trials. After antibiotic therapy, 59 of them took SER-109 once, and 30 – placebo. Eight weeks later, the clinical manifestations of infection resumed in 44 percent of the volunteers from the experimental group and 53 percent from the control group, which indicates the ineffectiveness of the drug. The frequency of side effects in the groups did not differ.

Roger Pomerantz, Executive Director of Seres Therapeutics, noted that the failure of the tests was a big surprise. According to him, the company will be engaged in a thorough analysis of clinical data and the intestinal microbiome of patients, as well as comparing this information with the results of a successful first phase of clinical trials.

Infection caused by C.difficile most often occurs in the form of severe pseudomembranous colitis, resistant to most existing antibiotics. In the USA alone, it claims about 30 thousand lives annually. In a number of studies systematically conducted since the 1980s, fecal transplantation has helped people with this disease. The procedure consists of taking whole feces from people with an optimal composition of the intestinal microbiome and introducing them to patients in the form of an enema or capsule for oral administration. Donor bacteria, multiplying, colonize the patient's intestines and inhibit the growth of clostridium and other pathogenic microorganisms. Currently, fecal transplantation and preparations based on it are being tested for ulcerative colitis, diabetes mellitus, obesity and other diseases. The perspective of the technique served to create three banks of excrement – two in the USA and one in the Netherlands.

Portal "Eternal youth" http://vechnayamolodost.ru  23.08.2016