ENROLL PATIENTS: VOWST Voyage™ Patient Support Program

VOWST clinical data

VOWST used following antibiotics was studied in a rigorous
phase 3 clinical development program^1,2

The 1-2 punch of an antibiotic followed by VOWST delivered superior, durable efficacy through 24 weeks^1-3

In a phase 3, randomized, placebo-controlled trial, VOWST resulted in statistically significant
reduction of C. diffa infection recurrence at both 8b and 24 weeksc vs antibiotics alone.^1-3

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18
years of age and older following antibacterial treatment for recurrent CDI (rCDI).²

**Percentage of participants without C. diff infection recurrence at 8 weeksb and 24 weeks^1-3,c**

The 1-2 gut punch of VOWST following antibiotics can increase your patient’s odds of beating another recurrence^1-3

^aClostridioides difficile (C. diff) infection.
^bCalculated by the rate of C. diff recurrence, which was significantly lower in VOWST recipients compared with those receiving antibiotics alone—12% vs 40%, respectively—a 0.32 relative risk (95% CI, 0.18, 0.58; P<0.001).¹
^cRelative risk of 0.46 (95% CI, 0.30, 0.73; P<0.001).³

ECOSPOR III: Clinical Study Design

Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with rCDI^a,b

Primary Endpoint

Recurrence at 8 weeks^2,3,c

Secondary Endpoints

Adverse events within 24 weeks and recurrence at 4, 12, and 24 weeks^2,3,d

Recurrence confirmed with C. diff^e toxin test and ≥3 unformed bowel movements per day for 2+ consecutive days.²

Participants received 10-21 days of vancomycin or fidaxomicin.^1,4

^aInclusive of current episode.⁴
^bEfficacy endpoints based on intent-to-treat population.
^cRecurrence was defined as ≥3 unformed stools per day for 2 consecutive days and continued diarrhea until antibiotic treatment and a positive toxin assay.¹
^dParticipants were stratified by antibiotic received (vancomycin or fidaxomicin) and age (<65 or ≥65 years) and randomized 1:1 to receive VOWST or placebo.¹
^eDue to logistics of drug or placebo delivery at some trial sites, 6 participants skipped their original randomization assignment based on available site supply. However, these participants were analyzed according to their intended assignment. Safety was assessed in the as-treated population.¹

Demographic and Clinical Characteristics of the Participants at Baseline (ITT Population)^1,5

Baseline characteristics were balanced between groups, although women represented a larger percentage of participants in the VOWST group compared with placebo.

Inclusion Criteria^1,2

≥18 years of age
Confirmed diagnosis of rCDI, defined as:

≥3 unformed stools/day for 2 consecutive days
A positive C. diff stool toxin assay

Symptom resolution following 10 to 21 days of SOC antibiotic treatment with vancomycin or fidaxomicin

Symptom resolution was defined as <3 unformed stools in 24 hours for 2 or more consecutive days

≥3 episodes of CDI (≥2 recurrences) within the previous 12 months, inclusive of the acute episode

Exclusion Criteria^1,4

Known or suspected toxic megacolon and/or known small bowel ileus
Neutropenia (absolute neutrophil count of <500 cells/mm3)
History of active inflammatory bowel disease (IBD) with IBD a believed cause of diarrhea within past 3 months

^aClostridioides difficile (C. diff) infection.
CDI, C. diff infection; ITT, intent to treat; rCDI, recurrent C. diff infection; SOC, standard of care.

In phase 3 clinical trials, VOWST taken after antibiotics
was proven to be generally well tolerated^2,6

Incidence of most common adverse reactions compared with antibiotics alone through 8 weeks²

^aThe safety population was defined as all ECOSPOR III randomized participants who received a dose of study medication, by treatment received. 85/90 participants in the VOWST group and 64/92 participants in the placebo group completed the 8-week follow-up.² Data were rounded to the nearest whole number for presentation.
^bSolicited adverse events were recorded by participants in a diary for 7 days after completion of the 3-day regimen of VOWST or placebo. Participants were monitored for unsolicited events by queries during visits for a period of 8 weeks after the first dose of study drug.²

**VOWST was used as early as first *C. diff recurrence in ECOSPOR IV

Percentage of participants without C. diffa recurrence at 8 weeks, assessed by number of prior recurrences.
In the overall study population, 91% were recurrence free at 8 weeks (N=263).

At 24 weeks, 86% of participants remained recurrence free

This open-label, single-arm study evaluated the safety and tolerability of VOWST up to 24 weeks.⁶

Limitations: Open-label, single-arm study design yields descriptive results limiting interpretations of efficacy and safety without a comparator.

^aClostridioides difficile (C. diff) infection.

ECOSPOR IV: Clinical Study Design

Multicenter, open-label, single-arm trial in adults (≥18 years) with rCDI^6,a

Primary Endpoint

Adverse events within 24 weeks

Secondary Endpoints

Recurrence at 4, 8, 12, and 24 weeks

Recurrence confirmed with C. diff^b toxin test or PCR and ≥3 unformed bowel movements per day for 2+ consecutive days.^c

Inclusion Criteria⁶

Cohort 1

Previously enrolled in ECOSPOR III and experienced a C. diff^b recurrence within 8 weeks after receipt of a treatment regimen

Cohort 2

≥18 years of age
≥1 confirmed CDI recurrence, defined as:

≥3 unformed stools/day for 2 consecutive days
A positive C. diff stool toxin assay or PCR assay
Symptom resolution following SOC CDI antibiotic therapy

Exclusion Criteria⁶

Known or suspected toxic megacolon and/or known small bowel ileus
Absolute neutrophil count of <500 cells/mm3
History of active inflammatory bowel disease (IBD) with IBD believed cause of diarrhea within past 3 months

^aInclusive of current episode.⁶
^bParticipants who were lost to follow-up, terminated the study prematurely, or died without a recorded recurrence before the end of the time interval were assumed to have had a recurrence.⁶
^cClostridioides difficile (C. diff) infection.⁶
^dToxin or PCR testing was utilized to determine initial eligibility. Recurrences while on study were confirmed by toxin testing to ensure study integrity.⁶
^e25 placebo recipients and 4 VOWST recipients discontinued ECOSPOR III and enrolled in ECOSPOR IV.⁶
PCR, polymerase chain reaction; rCDI, recurrent C. diff infection; SOC, standard of care.

In phase 3 clinical trials, VOWST taken after antibiotics
was proven to be generally well tolerated^2,6

An open-label, single-arm trial with a primary endpoint that
evaluated the safety and tolerability of VOWST up to 24 weeks^2,6,a

The most commonly reported adverse reactions were gastrointestinal in nature, namely flatulence, diarrhea, and nausea²
The majority of adverse reactions were mild or moderate in severity^2,6
The open-label, single-arm study design yields descriptive results and limits the interpretation of efficacy and safety data without a comparator⁶

^aThe ECOSPOR IV open-label, single-arm trial primary endpoint evaluated the safety and tolerability of VOWST up to 24 weeks. Study population was comprised of 2 cohorts. Cohort 1: 29 patients previously in ECOSPOR Ill with Clostridioides difficile recurrence within 8 weeks after VOWST or antibiotics alone. Cohort 2: 234 new patients receiving VOWST with at least 1 C. diff recurrence that responded to C. diff antibiotic therapy.⁶
^bAll adverse events collected were unsolicited.²
^cData were rounded to the nearest whole number for presentation.⁶

SEE THE SCIENCE OF VOWST

ENROLL YOUR PATIENTS IN VOWST VOYAGE™

References: 1. 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(3):220-229. doi:10.1056/NEJMoa2106516 2. VOWST [Prescribing Information]. Bridgewater, NJ: Aimmune Therapeutics, Inc. 02/2025. 3. 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 4. 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(3):(suppl). doi:10.1056/NEJMoa2106516 5. Data on File. Seres Therapeutics and Nestlé Health Science; 2023. 6. Sims MD, Khanna S, Feuerstadt P, et al; ECOSPOR IV Investigators. 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

VOWST clinical data

VOWST used following antibiotics was studied in a rigorous phase 3 clinical development program1,2

The 1-2 punch of an antibiotic followed by VOWST delivered superior, durable efficacy through 24 weeks1-3

Percentage of participants without C. diff infection recurrence at 8 weeksb and 24 weeks1-3,c

In phase 3 clinical trials, VOWST taken after antibiotics was proven to be generally well tolerated2,6

Incidence of most common adverse reactions compared with antibiotics alone through 8 weeks2

VOWST was used as early as first C. diff* recurrence in ECOSPOR IV

At 24 weeks, 86% of participants remained recurrence free

This open-label, single-arm study evaluated the safety and tolerability of VOWST up to 24 weeks.6

In phase 3 clinical trials, VOWST taken after antibiotics was proven to be generally well tolerated2,6

An open-label, single-arm trial with a primary endpoint that evaluated the safety and tolerability of VOWST up to 24 weeks2,6,a

VOWST used following antibiotics was studied in a rigorous
phase 3 clinical development program^1,2

The 1-2 punch of an antibiotic followed by VOWST delivered superior, durable efficacy through 24 weeks^1-3

**Percentage of participants without C. diff infection recurrence at 8 weeksb and 24 weeks^1-3,c**

In phase 3 clinical trials, VOWST taken after antibiotics
was proven to be generally well tolerated^2,6

Incidence of most common adverse reactions compared with antibiotics alone through 8 weeks²

**VOWST was used as early as first *C. diff recurrence in ECOSPOR IV

This open-label, single-arm study evaluated the safety and tolerability of VOWST up to 24 weeks.⁶

In phase 3 clinical trials, VOWST taken after antibiotics
was proven to be generally well tolerated^2,6

An open-label, single-arm trial with a primary endpoint that
evaluated the safety and tolerability of VOWST up to 24 weeks^2,6,a