Seres Therapeutics Announces Completion of Patient Enrollment for SER-155 Phase 1B Cohort 2 Clinical Trial in Allogenic HSCT
Seres Therapeutics, Inc. (MCRB) completes enrollment in SER-155 Phase 1b trial for Allo HSCT patients, aiming to reduce infections and improve outcomes. Clinical data readout expected by end of Q3 2024. Potential to expand microbiome therapeutic franchise into other medically vulnerable patient populations.
From a medical research perspective, the completion of enrollment in the placebo-controlled Cohort 2 of Seres Therapeutics' Phase 1b trial of SER-155 is a significant milestone. The focus on patients post-Allogeneic Hematopoietic Stem Cell Transplantation is critical, as this group is highly susceptible to infections due to their compromised immune systems. The development of SER-155, which aims to reduce the incidence and severity of enteric-derived infections, could be transformative for patient care. The implications of successful clinical results are far-reaching, potentially reducing the high mortality rates associated with infections in this vulnerable population.
Moreover, the design of SER-155 to induce immune tolerance and reduce Graft versus Host Disease (GvHD) incidence is a novel approach in the realm of immunomodulation. The anticipated data readout by the end of Q3 2024 will offer insights into the safety, drug pharmacology and efficacy of SER-155. The initial data from Cohort 1 showing favorable tolerability and successful engraftment of the drug bacteria set a positive precedent for the upcoming results. If the outcomes from Cohort 2 corroborate these findings, this could signify a breakthrough in microbiome therapeutics for immunocompromised patients.
The economic impact of SER-155, if proven effective, could be substantial for the healthcare system. Considering the estimated 40,000 annual Allo HSCT procedures worldwide, the financial burden of managing infections, including those with antibiotic resistance, is considerable. An effective microbiome therapeutic could potentially reduce hospital stays, the need for expensive antibiotics and improve overall patient outcomes. This could translate into significant cost savings for healthcare providers and insurers.
Long-term, if SER-155 extends its applications to other medically vulnerable populations such as those with chronic liver disease, cancer neutropenia and solid organ transplants, the economic implications could scale up. The preventative nature of SER-155 aligns with the broader healthcare trend towards value-based care, where reducing the incidence of severe infections can lower long-term costs and improve the quality of life for patients. This preventative approach is gaining traction in the healthcare industry and could be a key driver for adoption if SER-155 enters the market.
The announcement by Seres Therapeutics regarding the completion of enrollment for their Phase 1b trial of SER-155 has potential market implications. Investors often closely monitor clinical trial progress, as it serves as an indicator of a company's future prospects. Positive results from this trial could lead to an increase in investor confidence and potentially boost Seres Therapeutics' stock value. Furthermore, the ability of SER-155 to address a high unmet medical need in a sizeable global market presents a substantial commercial opportunity.
The strategic intention to expand the microbiome therapeutic franchise into additional patient populations demonstrates foresight and growth potential. However, it is important to note that the biotech sector is highly volatile, with stock prices sensitive to clinical trial outcomes. The market will be watching for the late Q3 2024 data readout, which could be a pivotal event for the company. Should the results be favorable, Seres Therapeutics may secure a leading position in the niche market of microbiome therapeutics for immunocompromised patients.
04/09/2024 - 07:00 AM
Clinical data readout expected end of Q3 2024
SER-155 and other Seres microbiome therapeutic candidates have potential to expand microbiome therapeutic franchise into additional medically vulnerable patient populations
CAMBRIDGE, Mass. --(BUSINESS WIRE)--
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its Phase 1b trial of SER-155 in patients who received Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT). SER-155 is an orally administered, consortium of bacteria, cultivated from cell banks and designed to reduce the incidence and severity of enteric-derived infections and resulting bloodstream infections, including those that may harbor antibiotic resistance. Infections are a leading cause of mortality and morbidity in this immunocompromised patient population. SER-155 is also designed to induce immune tolerance responses to reduce the incidence of GvHD.
“We are pleased to complete enrollment in Cohort 2 of our SER-155 Phase 1b study and are looking forward to a robust dataset late in the third quarter of this year,” said Eric Shaff, President and Chief Executive Officer of Seres. “The initial study data will include safety, drug pharmacology, and efficacy-related measures through day 100 following HSCT, a period in which many patients experience infections. There are an estimated 40,000 Allo HSCT procedures annually worldwide and infection is one of the most common causes of mortality in these patients. Our pending clinical results could validate the promise of microbiome therapeutics to prevent poor outcomes associated with pathogens in the GI tract. We intend to evaluate SER-155 and other microbiome therapeutic candidates in several other high prevalence, medically vulnerable patient populations, including chronic liver disease, cancer neutropenia, and solid organ transplants. We envision a future where Seres is pioneering a new standard of care, potentially protecting millions of immunocompromised patients from life-threatening infections.”
The SER-155 Phase 1b study (NCT04995653 ) is being conducted across 13 clinical centers in the US, including Memorial Sloan Kettering. Study Cohort 1, which included 13 participants, was designed to assess safety and drug pharmacology, including the engraftment of drug bacteria in the gastrointestinal tract. Cohort 1 clinical data, announced in May 2023, showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal microbiome. Study Cohort 2, which includes 45 participants, incorporates a randomized, double-blinded placebo-controlled 1:1 design to further evaluate safety and engraftment, as well as clinical outcomes.
About SER-155
SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development MbTx platform technologies. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays, and in vivo disease models. The SER-155 composition is designed to prevent and decrease the colonization and abundance of bacterial pathogens that can harbor antibiotic resistance and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections and GvHD. SER-155 has received FDA Fast Track Designation.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval in April 2023 as the first orally administered microbiome therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. For more information, please visit www.serestherapeutics.com .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about the timing and results of our clinical studies, the promise and potential therapeutic impact of microbiome therapeutics, future product candidates and development plans, and other statements which are not historical fact.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our 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: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our novel approach to therapeutic intervention; our reliance on third parties to conduct our clinical trials and manufacture our product candidates; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), on March 5, 2024, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240409318064/en/
Investor and Media Contact:
IR@serestherapeutics.com
Source: Seres Therapeutics, Inc.
What is the purpose of SER-155 Phase 1b trial?
The purpose of the SER-155 Phase 1b trial is to assess the safety, drug pharmacology, and efficacy-related measures of SER-155 in patients who received Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT), with the goal of reducing infections and improving outcomes.
What are the key features of SER-155?
SER-155 is an orally administered consortium of bacteria designed to reduce the incidence and severity of enteric-derived infections and resulting bloodstream infections, including those that may harbor antibiotic resistance. It is also intended to induce immune tolerance responses to reduce the incidence of GvHD.
How many participants are involved in the SER-155 Phase 1b study?
The SER-155 Phase 1b study involves 45 participants in Cohort 2, which includes a randomized, double-blinded placebo-controlled 1:1 design to evaluate safety, engraftment, and clinical outcomes.
What were the results of Cohort 1 of the SER-155 Phase 1b study?
Cohort 1 of the SER-155 Phase 1b study showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal microbiome.
Where is the SER-155 Phase 1b study being conducted?
The SER-155 Phase 1b study is being conducted across 13 clinical centers in the US, including Memorial Sloan Kettering.
