Medically reviewed by Onikepe Adegbola, MD, PhD
Today, Seres Therapeutics, Inc. released confirmed findings from ECOSPOR IV, an open-label trial for SER-109, an experimental oral microbiome treatment for the prevention of recurrent C. difficile infection (rCDI). Consistent with the safety profile reported in the earlier placebo-controlled ECOSPOR III trial, the overall safety profile observed in ECOSPOR IV through 24 weeks suggested that SER-109 was well tolerated. The ECOSPOR III and ECOSPOR IV trials finish the Phase 3 development program for SER-109.
In ECOSPOR IV, individuals treated with SER-109 had an 8.7% recurrence rate after eight weeks, indicating a 91.3 percent sustained clinical response, which is comparable to the 88.2% rate found in ECOSPOR III. At eight weeks, participants with a first CDI recurrence (29 percent of subjects in the ECOSPOR IV research) had a CDI recurrence rate of 6.5 percent, but subjects with two previous CDI episodes (ECOSPOR III inclusion criteria) had a CDI recurrence rate of 9.7 percent. At 24 weeks, 13.7% of all participants treated with SER-109 had a CDI recurrence. This research contributes to the FDA’s (Food and Drug Administration) established safety database criteria for SER-109.
“The ECOSPOR IV findings validate the well-tolerated safety profile and therapeutic benefit shown in the preceding ECOSPOR III trial,” said Eric Shaff, President, and CEO of Seres. “Together, these findings and the initiation of the rolling BLA filing greatly enhance our capacity to provide what may be the first microbiome-based therapy authorized by the FDA. We think that SER-109 has the potential to radically improve the management of all 170,000 annual instances of rCDI in the United States and are collaborating closely with Aimmune Therapeutics, a Nestlé Health Science Company, to expeditiously deliver this treatment candidate to patients.”
In addition to the results from the SER-109 ECOSPOR III trial (NCT03183128), the ECOSPOR IV data will be submitted to the FDA as part of the rolling submission of the BLA. While the ECOSPOR III results alone will serve as the effectiveness foundation for Seres’ BLA filing, the FDA has sought safety data from at least 300 individuals treated with SER-109 at the commercial dosage. It is anticipated that safety data from both ECOSPOR IV and ECOSPOR III will satisfy this need and conclude Seres’ Phase 3 program for SER-109. Seres has commenced the rolling submission of the SER-109 BLA and expects the submission to be complete by mid-2022. Seres expects a possible launch of SER-109 in the first half of 2023 as a consequence of SER-109’s Breakthrough Therapy designation from the FDA, which might result in a priority evaluation of the application.
The ECOSPOR IV (NCT03183141) trial comprised two cohorts of adult individuals with rCDI and provided 24-week data for an additional 263 patients given SER-109. Participants in the research had a clinical profile similar to those regularly examined and treated in clinical practice. Through 24 weeks of follow-up, the overall safety profile of SER-109 was similar to the safety profile reported in ECOSPOR III, indicating that it was well tolerated. Similar low recurrence rates were seen in critical subpopulations after eight weeks, including those with a first recurrence (6.5%), a second recurrence (6.1%), and three or more recurrences (less than 1%). (13.8 percent ). In addition, the study permitted initial CDI diagnosis to be established with either toxin or PCR, reflecting the heterogeneity across local medical practices; on-study recurrences remained to be validated by toxin to maintain the integrity of the research data.
“The 91.3% sustained clinical response rate observed at eight weeks in the overall study population with recurrent CDI, including those with the first recurrence, reaffirms the superior efficacy and favorable safety profile previously observed in the pivotal placebo-controlled ECOSPOR III trial,” stated Paul Feuerstadt, MD, FACG, AGAF, Yale School of Medicine and lead author of the New England Journal of Medicine (NEJM) paper. “As a treating physician, I anticipate the future approval of this significant treatment alternative for patients suffering from this difficult and severe condition.”
Additional Information Regarding the ECOSPOR III and ECOSPOR IV Research
182 people with rCDI were included in the multicenter, randomized, placebo-controlled ECOSPOR III (SERES-012) research. In January, the New England Journal of Medicine reported that eight weeks after therapy, 88% of participants in the SER-109 group were free of C. difficile recurrence, compared to 60% of subjects in the placebo group. At six months post-treatment, 79 percent of the SER-109 group remained C. difficile recurrence-free, compared to 53 percent of the placebo group, confirming the long-lasting remission.
ECOSPOR IV (SERES-013): An open-label extension of ECOSPOR III and an open-label program for testing SER-109 in 263 adult individuals with rCDI at the commercial dosage in order to satisfy FDA criteria for the SER-109 safety database. The length of the trial for both cohorts was roughly 27 weeks, comprised of a 3-week screening phase, an 8-week main efficacy period, and a 16-week follow-up period. At eight weeks, the group as a whole had a positive safety profile and a 91 percent sustained clinical response. At 24 weeks post-treatment, 86% of SER-109-treated patients had a sustained clinical response. Complete ECOSPOR IV data will be submitted for presentation at a future scientific conference and publishing in a medical journal.
In July 2021, Seres and Nestlé Health Science came into an agreement to jointly market SER-109 in the United States and Canada. Under the terms of the agreement, Nestlé Health Science will deploy its worldwide pharmaceutical company, Aimmune Therapeutics, as the principal commercialization party. Upon FDA approval of SER-109, Seres will earn an extra $125 million in licensing fees. If accomplished, the deal also contains sales goals with a maximum value of $225 million. In the United States, Seres will be responsible for development and pre-commercialization expenses. Seres will be entitled to a sum equivalent to fifty percent of the commercial revenues upon commercialization.
Regarding SER-109
Oral microbiome treatment candidate SER-109 is composed of a consortium of highly pure Firmicutes spores, which are generally present in a healthy microbiome. SER-109 is intended to prevent recurrences of CDI by restoring the microbiome to a condition that is resistant to C. difficile colonization and proliferation. The SER-109 manufacturing purification procedure is intended to eliminate undesired microorganisms, hence minimizing the risk of disease transmission beyond that of donor screening alone. The U.S. FDA has designated SER-109 as both a Breakthrough Therapy and an Orphan Drug for the prevention of rCDI.
Concerning Seres Therapeutics
Seres Therapeutics, Inc. is a leading microbiome therapeutics firm creating a unique class of multifunctional bacterial consortia meant to engage functionally with host cells and tissues in order to cure illness. The SER-109 program of Seres produced the first-ever favorable pivotal clinical findings for a targeted microbiome medication candidate and has been designated by the FDA as a Breakthrough Therapy and Orphan Drug. The SER-109 program is being pushed to prevent recurrences of C. difficile infection and has the potential to become the first microbiome treatment licensed by the FDA. Seres is evaluating SER-155 in a Phase 1b study in patients undergoing allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections, and graft-versus-host disease, in addition to additional preclinical stage programs focusing on Infection Protection in medically compromised patients. Additionally, the company is doing research to aid the continued development of microbiome-based treatments for ulcerative colitis.
Forward-Looking Statements
This news release includes forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to historical facts should be considered forward-looking statements, including the ultimate efficacy and safety profile of SER-109; Seres’ receipt of potential milestone payments, including the ability to achieve the targets and receive any milestone payments from Nestlé Health Science; the potential market for SER-109; the timing and potential FDA review and approval of SER-109, including the exclusion of certain indications; the potential market for SER-109; and the potential market for
These forward-looking statements are based on the present expectations of Seres’s management. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties, and other important factors that could cause Seres’ actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to the following: Seres has incurred significant losses, is not currently profitable, and may never become profitable; Seres has incurred significant losses, is not currently profitable, and may never become profitable; Seres has incurred significant losses, These and other important factors discussed under the heading “Risk Factors” in Seres Therapeutics, Inc.’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 4, 2022, and their other reports filed with the SEC could cause actual results to differ materially from those projected in this press release. These forward-looking statements reflect the estimations of Seres’s management as of the date of this news release. Seres disclaims any duty to update any forward-looking statements in the future, even if subsequent events cause its views to alter. These forward-looking statements do not reflect Seres’ opinions as of any date subsequent to the date of this news release.
Reference
Business Wire. (2022, June 7). Seres Therapeutics Announces Confirmatory Results from Investigational Microbiome Therapeutic SER-109 ECO. Benzinga. Retrieved June 24, 2022, from https://www.benzinga.com/pressreleases/22/06/b27582595/seres-therapeutics-announces-confirmatory-results-from-investigational-microbiome-therapeutic-ser-?utm_campaign=partner_feed&utm_source=yahooFinance&utm_medium=partner_feed&utm_content=site
