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Seres Therapeutics, Inc. (Nasdaq: MCRB) is a pioneering clinical-stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products. These novel drugs aim to treat significant diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is at the forefront of creating the first therapeutics that induce a shift towards health by enhancing the microbiome's biology.
The company operates primarily in the United States, leveraging its microbiome therapeutics platform to develop Ecobiotic™ microbiome therapeutics. These therapies are designed to restore health by repairing the function of a dysbiotic microbiome, particularly in the colon. Seres' lead product, SER-109, is developed to prevent the recurrence of Clostridium difficile infection (CDI), a severe infection of the colon. Additional product candidates include SER-262, SER-287, and SER-401.
Recently, Seres announced the sale of its VOWST assets to Nestlé Health Science under a non-binding memorandum of understanding. This transaction will provide Seres with capital infusions, including an upfront payment, and is expected to be completed in the next 90 days, subject to shareholder approval and other conditions. VOWST, the first FDA-approved oral microbiome therapy, prevents the recurrence of CDI in adults following antibacterial treatment for recurrent CDI.
Seres plans to use the capital from this transaction to retire its existing debt and strengthen its financial position. The company is also advancing SER-155, evaluated in a Phase 1b study in patients undergoing allogeneic hematopoietic stem cell transplantation. SER-155 has the potential to reduce gastrointestinal and related bloodstream infections, as well as acute graft-versus-host disease.
Seres Therapeutics continues to innovate in microbiome therapeutics, aiming to benefit multiple underserved patient groups, including those with chronic liver disease, cancer neutropenia, and solid organ transplants. The company's approach could protect millions of medically vulnerable patients from life-threatening infections while addressing the global public health issue of antimicrobial resistance (AMR).
Seres Therapeutics (Nasdaq: MCRB) announced promising results from its Phase 3 ECOSPOR III study of SER-109, an oral microbiome therapeutic aimed at reducing recurrent C. difficile infections (rCDI). The exploratory analysis revealed SER-109 significantly lowered rCDI risk in patients with pre-existing factors, such as those on acid-reducing medications. At 8 weeks, SER-109 showed an absolute recurrence reduction of 27% compared to placebo, translating to a 68% relative risk decrease. The study has potential implications for healthcare providers regarding treatment decisions for at-risk patients.
Seres Therapeutics (MCRB) announced significant findings from its Phase 3 ECOSPOR III study of SER-109, an oral microbiome therapy for recurrent C. difficile infection. The study demonstrated a substantial reduction in antimicrobial resistance genes (ARGs) in patients receiving SER-109 compared to placebo, with effects seen by Week 1 and lasting through Week 8. Results showed an 88% clinical response rate and a 27% reduction in recurrence rates at eight weeks. Seres plans to file a Biologics License Application with the FDA in mid-2022.
Seres Therapeutics (MCRB) announced the presentation of Phase 3 ECOSPOR III study data for SER-109 at IDWeek 2021, highlighting its significant impact on health-related quality of life and recurrence reduction for recurrent C. difficile infection (rCDI). SER-109 demonstrated improved health scores and reduced recurrence rates among patients with comorbidities. Additionally, SER-155 showed promise in decolonizing antibiotic-resistant pathogens. SER-109 has received Breakthrough Therapy and Orphan Drug designations from the FDA, enhancing its development prospects.
Seres Therapeutics (MCRB) has achieved enrollment of 300 subjects in the ECOSPOR IV study for SER-109, an oral microbiome therapy targeting recurrent C. difficile infection (rCDI). This milestone is crucial for the upcoming Biologics License Application (BLA) submission planned for mid-2022. SER-109 has shown a 30.2% reduction in rCDI recurrence and is positioned to be the first FDA-approved microbiome therapy. The deal with Nestlé Health Science includes a $175 million upfront payment and potential further milestones, highlighting a significant financial backing for Seres.
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced participation in three investor conferences. Management will engage in a pre-recorded fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. Additionally, a fireside chat is scheduled for September 15, 2021, at the Morgan Stanley 19th Annual Global Healthcare Conference. Lastly, Seres will hold investor meetings during the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on September 22, 2021. Webcast replays will be available on their website post-event.
Seres Therapeutics (Nasdaq: MCRB) announced that Eric Shaff, President and CEO, will discuss the company at the Canaccord Genuity 41st Annual Growth Conference on August 11 at 9:00 a.m. ET. A webcast replay will be available on the company's website two hours post-event and will be archived for 21 days.
Seres Therapeutics specializes in microbiome therapeutics with its SER-109 program being a first-ever positive pivotal clinical result for a targeted microbiome drug candidate. The company is also advancing SER-301 and SER-155 in clinical studies.
Seres Therapeutics (Nasdaq: MCRB) announced its second quarter 2021 financial results, reporting a net loss of $48.3 million, up from $20.7 million year-over-year, primarily due to increased clinical expenses. The company highlighted significant progress with SER-109, nearing target enrollment for its safety study, and plans to file a Biologics License Application to obtain FDA approval. A license agreement with Nestlé Health Science will bolster funding and commercialization efforts for SER-109. However, SER-287's Phase 2b trial for ulcerative colitis did not meet primary endpoints, leading to the closure of parts of the study.
Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call on August 3, 2021, at 8:30 a.m. ET to discuss its second quarter 2021 results and provide a general business update. Interested parties can join by dialing 844-277-9450 (domestic) or 336-525-7139 (international), using conference ID 6519859. The company is a leader in microbiome therapeutics, with its SER-109 program achieving positive pivotal clinical results and receiving Breakthrough Therapy and Orphan Drug designations from the FDA for treating recurrent C. difficile infection.
Seres Therapeutics, Inc. (Nasdaq: MCRB) held a conference call to discuss topline results from the Phase 2b ECO-RESET study evaluating SER-287 for mild-to-moderate ulcerative colitis. The company has also advanced SER-109 for recurrent C. difficile infection, achieving positive pivotal clinical results and receiving Breakthrough Therapy and Orphan Drug designations from the FDA. Current evaluations include SER-301 and SER-155 in ongoing Phase 1b studies. The press release includes forward-looking statements highlighting potential challenges in profitability and clinical development.
Seres Therapeutics (MCRB) announced topline results from its Phase 2b ECO-RESET study of SER-287 for mild-to-moderate ulcerative colitis. The study failed to meet its primary endpoint for improving clinical remission rates compared to placebo, with remission rates of 10.3% and 10.6% for full and step-down doses respectively, against 11.6% for placebo. Adverse events were reported in 67.6% of subjects in the active treatment arms. Following these results, the company will close the open label portions of the study and focus on advancing SER-109, SER-301, and their early-stage pipeline.
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