Microbiota-based CDI treatment successful and safe, studies show
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An investigational therapy that uses the gut microbiome was safe and effective in treating recurrent Clostridioides difficile infection, according to data from five abstracts presented at IDWeek.
RBX2660 is a potential first-in-class microbiota-based live biotherapeutic. Data presented at the conference were from two phase 3 trials and three phase 2 trials investigating its use in adults.
“C. difficile infection (CDI) is an urgent public health threat, according to the CDC, and therefore represents a significant unmet medical need for patients suffering from this disease,” Lindy L. Bancke, PharmD, head of clinical development at Rebiotix, told Healio. “Currently, antibiotics are the standard of care for treatment of CDI and do treat the disease, but they're also a predominant risk factor for a vicious cycle of recurrence.”
According to Bancke, in order to ensure quality, safety, efficacy and patient access, an FDA-approved microbiome-based therapeutic is needed.
“That’s what led to the initiation of this development program over a decade ago — the significant patient and caregiver burden, the unmet medical need, and the opportunity to standardize and generate robust safety and efficacy data for a promising treatment and recurrent CDI,” she said.
In five prospective trials from a decade-long program, researchers aimed to assesses the safety and efficacy of RBX2660 as a preventive therapy for recurrent CDI, as well as its impact on the microbiome of study participants, according to a press release. Overall, the studies included 723 actively treated patients, all aged 18 years or older, who had at least one recurrence of CDI after a primary episode and who had completed at least one round of standard-of-care antibiotic therapy.
Overall, the studies demonstrated that RBX2660 consistently reduced the recurrence of CDI, with up to 78.9% of participants remaining free from recurrence for 8 weeks after treatment. During the study, patients who did not respond to the initial treatment were offered an additional treatment course, which increased the reduction in recurrence to 84.4%. Researchers reported that participants who responded to treatment remained CDI free for 6 months and up to 2 years.
Data from studies assessing safety revealed that the percentage of participants reporting treatment-emergent adverse events in the RBX2660 group was similar to that in the standard-of-care plus placebo group, with most adverse events being mild or moderate in severity and non-life threatening.
Additional data shared in the studies demonstrated that, among participants who responded to treatment, RBX2660 “significantly increased” gut bacteria associated with health, specifically Bacteroidia and Clostridia, and decreased gut bacteria associated with CDI pathology, Gammaproteobacteria and Bacilli, within 7 days of treatment. According to the studies, these effects were maintained 6 months after treatment.
In addition to removing harmful bacteria, RBX2660 also “appeared to remove potentially deadly antimicrobial-resistant bacteria from the gut microbiota and seemingly kept the number of these genes low for at least 6 months,” the press release explained.
Bancke said that, overall, the data confirm the consistent efficacy and safety profile of RBX2660.
“Across all of the presentations, we have the largest, most robust clinical development program conducted in the field of microbiome-based therapeutics for recurrent CDI and we have the most compelling science to help fill a vast unmet need for people suffering from recurrent CDI,” Bancke said.
Teena Chopra, MD, MPH, professor of internal medicine and infectious diseases at Wayne State University, said the incidence of C. difficile over the years has been frustrating and disappointing, marking a “major gap” in infectious diseases.
“You have a wish list as a physician, and on my wish list is for my patients to not come back with recurrent CDI. I want something that can break that cycle and improve the microbiome of patients,” Chopra, who was not involved in the studies, told Healio. “This gives us a lot of hope to treat these patients because it is consistent and reliable and has shown a sustained clinical response.”
References:
Bancke L, et al. Abstract 167. Presented at: IDWeek; Sept. 29-Oct. 3, 2021 (virtual meeting).
Blount K, et al. Abstract 1064. Presented at: IDWeel; Sept. 29-Oct. 3, 2021 (virtual meeting).
Braun T, et al. Abstract 1042. Presented at IDWeek; Sept. 29-Oct. 3, 2021 (virtual meeting).
Hau, H, et al. Abstract 129. Presented at: IDWeek; Sept. 29-Oct. 3, 2021 (virtual meeting).
Papazyan R, et al. Abstract 1039. Presented at: IDWeek; Sept 29-Oct. 3, 2021 (virtual meeting).
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