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Explore VOWST® mechanism of action, engraftment data, and manufacturing

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VOWST is used following antibiotics for a sequential dual approach to prevent recurrent C. diff*
(rCDI)1-5

After antibiotics eliminate harmful bacteria, VOWST is thought to rapidly facilitate restoration of the gut microbiome and inhibit the spore germination that can perpetuate the cycle of
C. diff recurrence1,5,†

ANTIBIOTICS Antibiotics used to treat recurrence can kill toxin-producing bacteria, but microbiome disruption and dormant spores may remain. C. diffC. diff 2-5 VOWST FOLLOWING ANTIBIOTICS VOWST increased beneficial Firmicutes bacteria within 1 week. 1,5,a VOWST is thought to inhibit spore germination and facilitate restoration of the gut microbiome. 1,5 C. diff Limitations: Engraftment data from exploratory analysis in ECOSPOR III yield descriptive results.The relationship between these data and efficacy or safety has not been established. b –specific antibiotics C. diff Beneficial bacteria Toxin-producing bacteria C. diff spores C. diff VOWST a Stool specimens for whole metagenomic sequencing were obtained at baseline and at weeks 1, 2, and 8. Of the 182 participants, 29 were excluded from analyses because of missing specimens or protocol deviations. The number of specimens available for analysis depended on the availability of baseline and post-treatment samples. ¹ b Engraftment was defined as the number of VOWST dose species detected after treatment that had not been present at baseline. ¹ –specific antibiotics C. diff Beneficial bacteria C. diff Toxin-producing bacteria spores C. diff VOWST ANTIBIOTICS Antibiotics used to treat recurrence can 2-5 killtoxin-producing bacteria, but microbiome disruption and dormant spores may remain. C. diff C. diff VOWST FOLLOWING ANTIBIOTICS 1,5,a VOWST increased beneficial Firmicutes bacteria within 1 week. 1,5 VOWST is thought to inhibit spore germination and facilitate restoration of the gut microbiome. C. diff b Engraftment data from exploratory analysis in ECOSPOR III yield descriptive results.The relationship between these data and efficacy or safety has not been established. Limitations: a Stool specimens for whole metagenomic sequencing were obtained at baseline and at weeks 1, 2, and 8. Of the 182 participants, 29 were excluded from analyses because of missing specimens or protocol deviations. The number of specimens available for analysis depended on the availability of baseline and post-treatment samples. ¹ b Engraftment was defined as the number of VOWST dose species detected after treatment that had not been present at baseline. ¹

A bimodal approach may be required to help address both the rCDI and dysbiosis of the microbiome1-5

*Clostridioides difficile (C. diff) infection.

† The mechanism of action of VOWST has not been established.6

Engraftment data from exploratory analysis in ECOSPOR III

VOWST is a purified bacterial spore suspension sourced from qualified donors and composed of Firmicutes spores.6

ECOSPOR III EXPLORATORY ENDPOINT
Limitations: 1,‡ Engraftment data yield descriptive results and the relationship between these data and efficacy or safety has not been established. Numbers of engrafting VOWST dose species were greater than antibiotics alone at week 1 and remained higher through week 8. Baseline Number of engrafting dose species 1,‡ ENGRAFTMENT OF VOWST DOSE SPECIES 74 79 66 69 60 64 66 56 100 50 0 Week 1 Week 2 Week 8 VOWST (n) ANTIBIOTICS ALONE (n) 1,‡ ENGRAFTMENT OF VOWST DOSE SPECIES Baseline Week 1 Week 2 Week 8 Number of engrafting dose species 74 66 60 66 79 69 64 56 100 50 0 VOWST (n) ANTIBIOTICS ALONE (n)

Limitations: Engraftment data yield descriptive results and the relationship between these data and efficacy or safety has not been established.

Numbers of engrafting VOWST dose species were greater than antibiotics alone at week 1 and remained higher through week 8.1,‡

‡Stool specimens for whole metagenomic sequencing were obtained at baseline and at weeks 1, 2, and 8. Of the 182 participants, 29 were excluded from analyses because of missing specimens or protocol deviations. The number of specimens available for analysis depended on the availability of baseline and post-treatment samples.1

A purified therapy backed by GoodNature™4,6,7

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1. SINGLE-SOURCE DONATION

Qualified donors are selected based on their microbiome attributes and medical history, with each course of therapy coming from a single donor.

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2. DONOR TESTING

Comprehensive and standardized screening is performed, with donations routinely tested for a panel of transmissible pathogens.

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3. PURIFICATION

Ethanol inactivation is designed to help remove vegetative/pathogenic bacteria, fungi, parasites, and viruses.§

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4. FILTRATION

The spore suspension undergoes a filtration and centrifugation process to remove solids and residual ethanol.

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5. FINAL PRODUCT

VOWST is a purified bacterial spore suspension sourced from qualified donors and containing between 1x106 and 3x107 Firmicutes spore colony forming units.

Approximately 1% of total mass of donor materials remains in final product.7

Learn more about the VOWST manufacturing process

§
VOWST may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
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Learn more about clinical results

Discover the data
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VOWST SAFETY

Explore the safety profile

SEE THE SAFETY DATA

ABX, antibiotics.

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;386:220-229. doi:10.1056/NEJMoa2106516 2. Vincent C, Miller MA, Edens TJ, et al. Bloom and bust: intestinal microbiota dynamics in response to hospital exposures and Clostridium difficile colonization or infection. Microbiome. 2016;4:12. doi:10.1186/s40168-016-0156-3 3. Chilton CH, Pickering DS, Freeman J. Microbiologic factors affecting Clostridium difficile recurrence. Clin Microbiol Infect. 2018;24(5):476-482. doi:10.1016/j.cmi.2017.11.017 4. McGovern BH, Ford CB, Henn MR, et al. SER-109, an investigational microbiome drug to reduce recurrence after Clostridioides difficile infection: lessons learned from a phase 2 trial. Clin Infect Dis. 2021;72(12):2132-2140. doi:10.1093/cid/ciaa387 5. Khanna S, Sims M, Louie TJ, et al. SER-109: An oral investigational microbiome therapeutic for patients with recurrent Clostridioides difficile infection (rCDI). Antibiotics (Basel). 2022;11(9):1234. doi:10.3390/antibiotics11091234 6. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 06/2024. 7. McChalicher C, Abdulaziz A, Zhou SS, et al. Manufacturing process of SER-109, a purified investigational microbiome therapeutic, reduces risk of coronavirus transmission from donor stool. Open Forum Infect Dis. 2022;9(9):ofac448. doi:10.1093/ofid/ofac448 8. Feuerstadt P, Theriault N, Tillotson G. The burden of CDI in the United States: a multifactorial challenge. BMC Infect Dis. 2023;23(132):1-8. doi:10.1186/s12879-023-08096-0 9. 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

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