Safety profile of VOWST® taken after antibiotics

VOWST taken after antibiotics was generally well tolerated¹

Incidence of most common adverse reactions compared with antibiotics alone through 8 weeks¹

The majority of adverse reactions were mild or moderate in severity¹
Most adverse reactions occurred within 10 days of starting VOWST
– The median duration of these events was ≤5 days¹
No serious adverse events were considered related to the use of VOWST¹

* Safety population consisted of randomized participants who received a dose of study medication and were analyzed according to the treatment received. Data were rounded to the nearest whole number for presentation.¹

^†Solicited adverse events were recorded by participants in a diary for 7 days after completion of the 3-day regimen of VOWST or antibiotics alone.¹

VOWST taken after antibiotics was generally well tolerated¹

Incidence of the most common adverse reactions in the open-label study¹

ECOSPOR IV was an open-label, single-arm trial with a primary endpoint that evaluated the safety and tolerability of VOWST up to 24 weeks²

All adverse events collected in ECOSPOR IV were unsolicited¹
The majority of adverse reactions were mild to moderate in severity¹

^‡ Study population comprised of 2 cohorts. Cohort 1: 29 participants previously in ECOSPOR III with C. diff recurrence within 8 weeks after VOWST or antibiotics alone. Cohort 2: 234 new participants receiving VOWST with at least 1 C. diff recurrence and responded to
C. diff antibiotic therapy. Data were rounded to the nearest whole number for presentation.^1-3

2-STEP
ORAL DOSING

that is self-administered at home

VOWST DOSING DETAILS

VOWST FOLLOWING ANTIBIOTICS PROVIDED SUPERIOR, DURABLE EFFICACY VS ANTIBIOTICS ALONE

in a phase 3 clinical development program^1,3,4

SEE ECOSPOR III STUDY RESULTS

ABX, antibiotics; rCDI, recurrent C. diff infection.

REFERENCES: 1. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 06/2024. 2. Sims MD, Khanna S, Feuerstadt P, et al. Safety and tolerability of SER-109 as an investigational microbiome therapeutic in adults with recurrent Clostridioides difficile infection: a phase 3, open-label, single-arm trial. JAMA Netw Open. 2023;6(2):e2255758. doi:10.1001/jamanetworkopen.2022.55758 3. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an oral microbiome therapy for recurrent Clostridioides difficile infection. N Engl J Med. 2022;386:220-229. doi:10.1056/NEJMoa2106516 4. Cohen SH, Louie TJ, Sims M, et al. Extended follow-up of microbiome therapeutic SER-109 through 24 weeks for recurrent Clostridioides difficile infection in a randomized clinical trial. JAMA. 2022;328(20):2062-2064. doi:10.1001/jama.2022.16476

ECOSPOR III
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with recurrent C. diff ^1-3
Primary Endpoint Recurrence at 8 weeks* Secondary Endpoints Adverse events within 24 weeks Recurrence at 4, 12, 24 weeks*
Recurrence confirmed with C. diff toxin test and ≥3 unformed bowel movements per day over 2 days*
10–21 days of vancomycin (125 mg QID) or fidaxomicin (200 mg BID)

ECOSPOR IV
Multicenter, open-label, single-arm trial in adults (≥18 years) with recurrent C. diff ⁵
Primary Endpoint Adverse events within 24 weeks Secondary Endpoints Recurrence at 4, 8, 12, 24 weeks
Recurrence confirmed with C. diff toxin test or PCR and ≥3 unformed bowel movements per day over 2 days^*
10–42 days of vancomycin or 10–25 days of fidaxomicin

Safety profile of VOWST® taken after antibiotics

VOWST taken after antibiotics was generally well tolerated1

VOWST taken after antibiotics was generally well tolerated1

2-STEP ORAL DOSING

VOWST FOLLOWING ANTIBIOTICS PROVIDED SUPERIOR, DURABLE EFFICACY VS ANTIBIOTICS ALONE

VOWST taken after antibiotics was generally well tolerated¹

VOWST taken after antibiotics was generally well tolerated¹

2-STEP
ORAL DOSING