Investigational Microbiome Therapeutic SER-109 Reduces Recurrence of Clostridioides Difficile Infection (CDI) Compared to Placebo, Regardless of Presence or Absence of Comorbidities Including Chronic Obstructive Disease (COPD) and Asthma
Conference Proceeding - Restricted Access
American Journal of Respiratory and Critical Care Medicine
RATIONALE: Exacerbations of chronic obstructive pulmonary disease [COPD] and asthma are often treated with antibiotics, which are the leading risk factor for Clostridiodes difficile infection (CDI). Clinical characteristics, including presence of comorbid conditions, are considered risk factors for recurrent CDI(rCDI). Incidence of CDI has been reported to be twice as high in patients with COPD compared to adults without COPD. We examined the efficacy of an investigational purified oral microbiome therapeutic, SER-109, compared to placebo in an exploratory analysis of patients with and without comorbidities, including COPD/asthma, who enrolled in ECOSPOR III, a Phase 3 randomized double-blind trial. METHODS: Adults with rCDI(≥3 episodes in 12 months) were screened at 75 US/CAN sites. After completing standard-of-care antibiotics, subjects with symptom resolution were randomized 1:1 to SER-109 (4 capsules x 3 days) or matching placebo. The primary endpoint was CDI recurrence (recurrent toxin+ diarrhea requiring treatment). In this exploratory analysis, we analyzed the rate of CDIrecurrence among SER-109 treated subjects compared to placebo in subgroups defined by absence or presence of 1 or ≥2 comorbid conditions. RESULTS: 281 subjects were screened and 182 were randomized (59.9% female; mean age 65.5 years). In the overall study population: 33.5%, 32.4% and 34.0% had 0, 1, or ≥ 2 comorbidities. The most common comorbidities included cardiac disease (23.6%), diabetes/insulin resistance (23.1%), and COPD/asthma (19.8%). As previously reported, SER-109 was superior to placebo in reducing CDIrecurrence rates (12.4% vs 39.8%, respectively); relative risk (RR), 0.32 [95% CI, 0.18-0.58; P
McGovern BH, Louie T, Cohen S, Sims M, Wang E, Wu H, et al. Investigational microbiome therapeutic SER-109 reduces recurrence of Clostridioides Difficile infection (CDI) compared to placebo, regardless of presence or absence of comorbidities including chronic obstructive disease (COPD) and asthma. Am J Respir Crit Care Med. 2022, 205:A2792.