Cambridge, Mass-based Seres Therapeutics recently announced its recent earnings and some of its ongoing studies and initiatives. They reported financial results for the third quarter which ended September 30, and within the earnings report they included their product, SER-109 (Vowst), which had a net sales of $7.6 million.
The company developed Vowst, its oral microbiota treatment to prevent recurrent Clostridioides difficile infection (rCDI) and it was FDA approved back in April.
"With a broad label and compelling clinical profile, the launch of Vowst is off to a great start, exceeding our sales expectations," Seres President and CEO Eric Shaff, said in a statement. "Performance metrics from this first full quarter of launch support our belief that the product is on track to deeply penetrate the rCDI market and fundamentally transform how this disease is managed.”
Vowst is indicated to prevent rCDI in adults following antibacterial treatment and is commercialized by Nestlé Health Science in collaboration with Seres.
What You Need to Know
The financial results for the third quarter of 2023 revealed net sales of $7.6 million, surpassing sales expectations.
Seres provided updates on its investigational therapeutic, SER-155, designed to prevent enteric-derived infections and reduce the incidence of graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Data from the ECOSPOR IV study, a multicenter, randomized, placebo-controlled, open-label study, highlighted the efficacy of SER-109 in preventing recurrent CDI.
In its earnings report, the company said its SER-155 phase 1b placebo-controlled cohort 2 data readout is anticipated in mid-2024. SER-155 is an oral, cultivated bacterial consortia investigational therapeutic designed to prevent enteric-derived infections and resulting blood stream infections, as well as induce immune tolerance responses to reduce the incidence of graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Gastrointestinal (GI) microbiome data from the first 100 days post HSCT in cohort 1 of the SER-155 phase 1b open-label study showed the successful engraftment of SER-155 bacterial strains and a substantial reduction in the cumulative incidence of pathogen domination, a biomarker associated with the risk of serious enteric infections and bloodstream infections, as well as GvHD. The tolerability profile observed was favorable, with no serious adverse events attributed to SER-155 administration.
What the Vowst Data Showed
In earlier reporting by Contagion, Seres shared data from its clinical studies. The ECOSPOR IV (NCT03183141) multicenter, randomized, placebo-controlled, open-label study included 2 cohorts of adults with rCDI. Enrolled patients had a clinical profile consistent with those frequently evaluated and treated in clinical practice.
The participants treated with SER-109 had a recurrence rate of 8.7% at 8 weeks, indicating a 91.3% sustained clinical response. At 24 weeks, 13.7% of all subjects treated with SER-109 had a CDI recurrence.
SER-109 was well-tolerated through 24 weeks. The safety profile observed in ECOSPOR IV was consistent with that of its preceding placebo-controlled study, ECOSPOR III. Together, these 2 trials complete the SER-109 phase 3 development program.
Seres is also participating in the Peggy Lillis Foundation’s 2023 State of C diff Virtual Town Hall, which is happening today at 6pm EST. This is a digital event open to the public. To learn more about the event go here.
Seres Therapeutics Reports Third Quarter 2023 Financial Results Including Vowst Net Sales of $7.6 Million. Seres Press release. November 2, 2023. https://ir.serestherapeutics.com/news-releases/news-release-details/seres-therapeutics-reports-third-quarter-2023-financial-results