ACTION, ENGRAFTMENT DATA,
Although the mechanism of action of VOWST has not been established,
VOWST IS THOUGHT TO RAPIDLY FACILITATE THE RESTORATION OF THE GUT MICROBIOME1,2
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
*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.
†Engraftment was defined as the number of VOWST dose species detected after treatment that had not been present at baseline.
ENGRAFTMENT DATA FROM EXPLORATORY
ANALYSIS IN ECOSPOR III
VOWST is a bacterial spore suspension sourced from
qualified donors and composed of Firmicutes spores6
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 81‡
‡ Stool specimens for whole metagenomic sequencing were obtained at baseline and at Weeks 1, 2, and 8. Engraftment is defined as detection of species after treatment but not at baseline. 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.
A PURIFIED THERAPY BACKED BY GOODNATURE™,
A SERES THERAPEUTICS PROGRAM5-7
Antibiotics do not restore the functionality of a disrupted
microbiome—a root cause of C. diff recurrence7-10
Qualified donors are selected based on their microbiome attributes and medical history, with each course of therapy coming from a single donor
Comprehensive and standardized screening is performed, with donations routinely tested for a panel of transmissible pathogens
Ethanol inactivation is designed to help remove vegetative/pathogenic bacteria, fungi, parasites, and viruses§
The spore suspension undergoes a filtration and centrifugation process to remove solids and residual ethanol
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 product7
§ VOWST may carry a risk of transmitting infectious agents.6 Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
VOWST requires no refrigeration and can be stored at room temperature
REFERENCES: 1. Feuerstadt P, Louie TJ, Lashner B, et al. N Engl J Med. 2022;236:220-229. doi: 10.1056/NEJMoa2106516. 2. Khanna S, Sims M, Louie TJ, et al. Antibiotics. 2022;11(9):1234. doi:10.3390/antibiotics11091234. 3. Vincent C, Miller MA, Edens TJ, et al. Microbiome. 2016;4(12):1-11. doi:10.1186/s40168-016-0156-3. 4. Theriot CM, Young VB. Ann Rev Microbiol. 2015;69:445-461. doi:10.1146/annurev-micro-091014-104115. 5. McGovern BH, Ford CB, Henn MR, et al. Clin Infect Dis. 2021;72(12):2132-40. doi:10.1093/cid/ciaa387. 6. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 04/2023. 7. McChalicher C, Abdulaziz A, Zhou SS, et al. OFID. 2022. doi: 10.1093/ofid/ofac448.