An Open-Label Study (ECOSPOR IV) to Evaluate the Safety, Efficacy and Durability of SER-109, an Investigational Oral Microbiome Therapeutic, in Adults With Recurrent Clostridioides difficile Infection (rCDI)

The rate of rCDI was low and durable, regardless of the number of prior episodes, supporting the potential benefit of microbiome repair following antibiotics for rCDI. Summary of Treatment-Emergent Adverse Events Within 8 Weeks After Treatment, Safety Population Cohort 1 Cohort 2 (N=234) n (%) Total (N=263) n (%) Randomized Treatment Arm in ECOSPOR III Total (N=29) n (%) SER-109 (N=4) n (%) Placebo (N=25) n (%) Any TEAE 4 (100.0) 15 (60.0) 19 (65.5) 118 (50.4) 137 (52.1) Most Frequently Reported TEAEs by Preferred Term (≥5% in any cohort)  Diarrhoea 1 (25.0) 9 (36.0) 10 (34.5) 49 (20.9) 59 (22.4)  Flatulence 0 4 (16.0) 4 (13.8) 16 (6.8) 20 (7.6)  Nausea 0 3 (12.0) 3 (10.3) 17 (7.3) 20 (7.6)  Abdominal pain 1 (25.0) 2 (8.0) 3 (10.3) 15 (6.4) 18 (6.8)  Fatigue 0 3 (12.0) 3 (10.3) 9 (3.8) 12 (4.6)  Urinary tract infection 0 0 0 12 (5.1) 12 (4.6)  Abdominal distension 1 (25.0) 3 (12.0) 4 (13.8) 7 (3.0) 11 (4.2) Related/Possibly Related TEAE 1 (25.0) 4 (16.0) 5 (17.2) 27 (11.5) 32 (12.2) Severe TEAEs 0 1 (4.0) 1 (3.4) 18 (7.7) 19 (7.2) Serious TEAEs 0 0 0 20 (8.5) 20 (7.6) Serious TEAEs Related/Possibly Related to Study Drug 0 0 0 0 0 Treatment-emergent AESIs 0 0 0 10 (4.3) 10 (3.8) TEAEs Leading to Death1 0 0 0 6 (2.6) 6 (2.3) Abbreviations: AESI = adverse event of special interest;TEAE = treatment-emergent adverse event Notes: Data presented are by subject. All TEAEs were collected and summarized from time of enrollment up to Week 8;Note: N is number of subjects in the Safety Population who are in the study at the beginning of the specified time interval. 1 TEAEs leading to death by preferred term included: congestive cardiomyopathy (1 subject), coronavirus infection and intestinal peforation (1 subect), death due to natural causes (1 subject), clostridium difficile infection (1 subject), necrotising fasciitis (1 subject), and pancreatic carcinoma (1 subject).

Manufacturing Process of SER-109, a Purified Investigational Microbiome Therapeutic, Reduces Risk of Coronavirus Transmission From Donor Stool.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may present risk to patients treated with donor-derived microbiome therapies when appropriate manufacturing controls and inactivation processes are lacking. We report that the manufacturing steps for SER-109, a purified investigational microbiome therapeutic developed to reduce risk of Clostridioides difficile recurrence, inactivate porcine epidemic diarrhea virus, a model coronavirus for SARS-CoV-2.