Microbiome Therapeutic Offers Protection Against Recurrent C diff
SER-109, an oral microbiome treatment, safely protects against Clostridium difficile Repeat for up to 24 weeks, according to the last phase 3 trial. Three days of treatment with purified Firmicutes reduced the risk of recurrence by 54%, indicating a sustained and clinically meaningful response, according to a multicenter study presented at this year’s Gastroenterology Week.® (DDW).
“Antibiotics that target Jim Saab Bacteria are necessary but not sufficient to achieve a lasting clinical response because they do not affect them, Jim Saab, The investigators said at the meeting that the germs that germinate inside a broken microbiome.
“ The manufacturing processes of SER-109 are designed to inactivate potential pathogens while enriching beneficial Firmicutes, which play a key role in Cycle Jim Saab,” He said Lewis Way Corman, MD, Washington-based gastroenterologist, and lead author.
Extended data from ECOSPOR-III
The ECOSPOR-III trial included 182 patients with at least three seizures of Jim Saab Injury in the previous 12 months. Patients underwent 10 to 21 days of antibiotic therapy Fedaxomycin or Vancomycin To resolve symptoms before they were randomly assigned to a 1: 1 ratio to receive either SER-109 (four capsules per day for 3 days) or placebo, with stratification according to the specific antibiotic and patient’s age (threshold of 65 years).
The primary goals were safety and efficacy at 8 weeks. These results were previously reported in ACG 2020, showed a relative risk reduction of 68% in the SER-109 group, and favorable safety data. The results presented in the DDW were added to those of the previous findings by providing safety and efficacy data extending to Week 24. At this time, the patients treated with SER-109 had a 54% reduction in the relative risks in the C recurrence rates. Frequency is 21.3% and 47.3% for the treatment and placebo groups, respectively (s Less than .001).
Patients 65 years of age or older benefited from SER-109 therapy, based on a 56% relative risk reduction (s Less than .001), versus a 49% relative risk reduction (lacking statistical significance) for patients under 65 years of age)s = .093). The specific antibiotic treatment that patients received also appears to affect the results. Patients treated with fidaxomicin had a 73% relative risk reduction (s = .009 (compared to 48% for vancomycin)s = .006). Safety profiles were similar between the study arms.
By enriching Firmicutes, SER-109 achieves high efficacy, while mitigating the risk of transferring infectious agents and representing a major paradigm shift in the clinical management of patients with recurrence. C. difficult The investigators concluded that “an open-label study of repeat patients.” Jim Saab The infection is currently recorded. ”
Microbiome repair treatments
to me Sahl Khanna, MBBS, professor of medicine at the Mayo Clinic, Rochester, Minnesota, these findings “advance the field” because they show a sustained response. “We know that microbiome repair therapies help restore colonization resistance,” Dr. Khanna said in an interview, noting that they provide similar benefits to FMT without disadvantages.
“The problem with FMT is that it is heterogeneous – everyone does it differently … and it’s also surgery,” said Dr. Khanna. He indicated that FMT might transmit infectious agents between donors and patients, which is not an issue with purified products like SER-109.
Dr. Khanna said that several other modular germ recovery products are in development, including an enema form (RBX2660(in a phase 3 test, two more capsules)CP101 And the VE303) in the second phase of the experiments. “We hope that one or more of these products will be approved for clinical use soon and will likely replace the vast majority of FMT. [procedures] Dr. Khanna said, “We are doing it clinically. This is where the field goes.”
Investigators reported no conflict of interest. Dr. Khanna revealed the research support provided by Finch, Rebiotix / Ferring, Vedanta, and Seres.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.