Tag Archives: SER-109

Seres Therapeutics To Host a Virtual Webcast Focused on SER-109 on May 27, 2020

In The News:

Seres Therapeutics to Host Virtual SER-109 Focused Symposium on May 27, 2020, Ahead of Phase 3 ECOSPOR III Study Read-Out

– Data from SER-109 Phase 3 study in recurrent C. difficile infection expected mid-2020 –

Seres Therapeutics, Inc.  announced that it will host a virtual webcast symposium focused on SER-109 as a potential new therapeutic option for recurrent Clostridioides difficile infection (CDI) on Wednesday,  May 27, 2020 from 8:30 to 9:30 a.m. ET.

During the event, Mark Wilcox, M.D., Professor of Medical Microbiology, University of Leeds, and Seres’ management will discuss the CDI patient burden, the ongoing SER-109 Phase 3 ECOSPOR III study and the potential for SER-109 to become the standard of care for recurrent CDI.

SER-109 is being evaluated in an ongoing Phase 3 study for the prevention of recurrence of CDI. SER-109 has obtained both Breakthrough Therapy Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).

Seres previously reported the completion of enrollment in the Phase 3 ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128), a multicenter, randomized 1:1, placebo-controlled study in patients with multiply recurrent CDI. ECOSPOR III has enrolled 182 patients. Seres expects to report SER-109 Phase 3 top-line results in mid-2020.

Based on prior discussions with the FDA, Seres believes that ECOSPOR III has the potential to be the single pivotal study supporting product registration; however, this will depend on the strength of the data, and additional safety data may be required. If approved, SER-109 has the potential to be the first FDA-approved therapy for CDI to treat the underlying cause of this disease, and the first approved microbiome drug for any human condition.

To join the live webcast, on May 27, 2020 at 8:30 a.m. ET, including presentation slides, please visit the “Investors & Media” section of the Seres website at www.serestherapeutics.com. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 4884302.                                                                                Webcast Link: https://edge.media-server.com/mmc/p/3qo4hxiv.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for approximately 21 days.

To view press release in its entirety please click on the following link:

http://ir.serestherapeutics.com/news-releases/news-release-details/seres-therapeutics-host-virtual-ser-109-focused-symposium-may-27#

 

 

Seres Therapeutics SER-109 Phase 3 Clinical Study For Recurrent C. diff. Infection Initiated

Seres Therapeutics Initiates SER-109 Phase 3 Study in Patients with Multiply

Recurrent C. difficile Infection

 

Jun. 12, 2017– Seres Therapeutics, Inc.

announced the initiation of its Phase 3 SER-109 clinical study (ECOSPOR III) in patients with multiply recurrent C. difficile infection. Based on recent interactions with the U.S. Food and Drug Administration (FDA), ECOSPOR III will now be designated a Phase 3 trial and the company expects that this single pivotal study may support SER-109 registration and approval.

“We are extremely pleased to be able to initiate the SER-109 Phase 3 ECOSPOR III study. If ECOSPOR III is successful, we believe this study could serve as the basis for SER-109 approval. Our goal is to have SER-109 approved as the first microbiome drug in this new field of medicine, and the first for patients with multiply recurrent C. difficile infection, an area of very high unmet need for patients in the U.S. and around the world,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres.

The ECOSPOR III Phase 3 study design incorporates direct learnings from prior SER-109 development efforts, as well as helpful feedback obtained from the FDA and study investigators. The study is expected to enroll approximately 320 patients with multiply recurrent C. difficile infection, randomized 1:1 to either SER-109 or placebo. The study is sized to contribute to an adequate safety database that may support product licensure. ECOSPOR III will utilize more than 100 clinical sites across the U.S. and Canada. The study’s primary endpoint will compare the reduction of C. difficile recurrence rates in subjects who receive SER-109 verses placebo at up to eight weeks after dosing.

The initiation of the SER-109 Phase 3 ECOSPOR III study triggers a $20 million milestone payment under the company’s previously announced development and commercialization collaboration agreement with Nestlé Health Science. In partnership with Nestlé Health Science, Seres plans to accelerate interactions with European regulatory agencies in the coming months to establish a path toward SER-109 product approval across Europe.

About SER-109 and C. difficile Infection

SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic for the treatment of multiply recurrent C. difficile infection. SER-109 is a biologically sourced consortium of bacterial spores designed to catalyze a shift in a dysbiotic gastrointestinal microbiome to a healthier state. The FDA has granted SER-109 both Breakthrough Therapy and Orphan Drug Designations.

C. difficile infection is one of the top three most urgent antibiotic-resistant bacterial threats in the United States according to the Centers for Disease Control. C. difficile is a leading cause of hospital acquired infection in the U.S. and is responsible for the death of approximately 29,000 Americans each year.

To read the article in its entirety please visit Seres Therapeutics Website:

http://serestherapeutics.com/about

Seres Therapeutics, Inc. Announced That It Has Initiated a Phase 1b Clinical Trial Evaluating SER-262 In Patients With Primary C. diff. Infection (CDI)

Seres Therapeutics Inc.  a leading microbiome therapeutics company, announced today that it has initiated a Phase 1b clinical trial evaluating SER-262 in patients with primary Clostridium difficile infection (CDI).

SER-262 is an Ecobiotic® rationally-designed, fermented microbiome therapeutic derived by a manufacturing process that does not require human donor material. SER-262 is the first synthetically-derived and designed microbiome therapeutic ever to reach clinical-stage development.

“We intend to continue to utilize our platform technology and unique knowledge of bioinformatics, microbiology, manufacturing and regulatory requirements to develop additional rationally designed microbiome therapeutics for serious diseases in each of our three therapeutic franchises: infectious disease, immunology and metabolic disease.”

SER-262, an oral capsule, contains a consortium of twelve bacterial strains in spore form. The strains included in SER-262 were selected based on multiple criteria including analysis of human microbiome data, efficacy in animal models of CDI, and bacterial strain level characterization.1 The composition of SER-262 was selected among Seres’ field-leading human microbiome library containing over 14,000 well-characterized strains of bacteria.

The SER-262 Phase 1b study, a 24-week randomized, placebo-controlled, dose escalation study is expected to enroll approximately 60 patients who have experienced a first episode of CDI. The primary endpoint of the study will compare the CDI recurrence rate between the SER-262 and placebo groups at up to 8 weeks after dosing.

Approximately 640,000 and 820,000 individuals in U.S. each year experience a primary occurrence of CDI, and about 25 percent will suffer from a subsequent recurrence.

“Advancing SER-262 to the clinic is a landmark event for Seres and the microbiome field in general. The SER-262 program has demonstrated our ability to rapidly develop a new class of synthetic microbiome therapeutics comprised of rationally designed bacterial compositions,” said Roger Pomerantz, M.D., President, Chief Executive Officer and Chairman of Seres. “We intend to continue to utilize our platform technology and unique knowledge of bioinformatics, microbiology, manufacturing and regulatory requirements to develop additional rationally designed microbiome therapeutics for serious diseases in each of our three therapeutic franchises: infectious disease, immunology and metabolic disease.

With the initiation of the SER-262 Phase 1b study in primary CDI, and the ongoing SER-109 Phase 2 study in multiply recurrent CDI, Seres now has ongoing microbiome clinical programs across the entire CDI population. Initial study results from the SER-109 Phase 2 study are expected in mid-2016.

About Seres Therapeutics
Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring Clostridium difficile infection (CDI) and is currently being evaluated in a Phase 2 study in recurring CDI.

The FDA has granted SER-109 Orphan Drug, as well as Breakthrough Therapy, designations. Seres’ second clinical candidate,

SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC).

For more information, please visit www.serestherapeutics.com.

Follow Seres Therapeutics  on Twitter @SeresTx.

 

To read article in its entirety click on the link below:

http://www.businesswire.com/news/home/20160707005525/en/Seres-Therapeutics-Announces-Initiation-Phase-1b-Clinical

C. diff. Prevention of Recurrent C. diff. Infection (RCDI), Seres Therapeutics Announces Achievement of Target Enrollment of SER-109 Phase 2 Study

In The News: May 2, 2016

Seres Therapeutics Announces Achievement of Target Enrollment of SER-109 Phase 2 Study for the Prevention of Recurrent Clostridium difficile Infection

Phase 2 data expected in mid-2016

New SER-109 Expanded Access Program initiated at Phase 2 clinical sites

Seres Therapeutics, Inc.  a leading microbiome therapeutics platform company, announced that the target enrollment of 87 patients has been achieved for its ongoing SER-109 Phase 2 clinical study.

SER-109 is an oral, potential first-in-field microbiome therapeutic that has been granted Orphan Drug and Breakthrough Therapy designations by the U.S. Food and Drug Administration (FDA), and is being investigated for use in preventing recurrent Clostridium difficile infection (CDI).

“We are pleased to reach this important milestone in our ongoing development of SER-109, which has the potential to be the first therapy for C. difficile infection to treat the underlying cause of this disease, and the first microbiome drug for a human disease. This is the first placebo controlled trial for patients with multiply-recurrent CDI,” said Roger Pomerantz, M.D., Chairman, President, and CEO of Seres. “C. difficile infection is an extremely serious condition responsible for approximately 29,000 deaths each year in the United States alone. We are moving with urgency to develop SER-109 as quickly and safely as possible. We expect initial results of the Phase 2 study in the middle of this year, and we plan to initiate a Phase 3 study later in 2016.”

The SER-109 Phase 2 study (ClinicalTrials.gov identifier: NCT02437487) is a multicenter, randomized, placebo-controlled study being conducted at approximately 40 centers across the U.S. The current study builds on a completed, successful Phase 1b/2 trial, which demonstrated that 87 percent of patients (26 of 30) met the predefined endpoint of preventing recurrent CDI within eight weeks following administration of SER-109. In that study 97 percent of patients (29 of 30) achieved a clinical cure during the eight-week period after SER-109 dosing, as defined by the absence of CDI requiring antibiotic treatment. Results from the Phase 1b/2 have been published in The Journal of Infectious Disease.1

The Company has initiated a SER-109 Expanded Access Program at selected sites participating in the ongoing Phase 2 study. The Expanded Access Program will enable eligible patients with multiply-recurrent CDI to have continued access to SER-109. Furthermore, maintaining Phase 2 study sites open ahead of the anticipated start of the Phase 3 study expected to support and augment Phase 3 study execution and enrollment.

About Seres Therapeutics
Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring Clostridium difficile infection (CDI) and is currently being evaluated in a Phase 2 study in recurring CDI. The FDA has granted SER-109 Orphan Drug, as well as Breakthrough Therapy, designations. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC). For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.

TO READ THE ARTICLE IN ITS ENTIRETY CLICK ON THE LINK BELOW:

http://ir.serestherapeutics.com/phoenix.zhtml?c=254006&p=irol-newsArticle&ID=2163658

Reference

1. Khanna S. et al., A novel microbiome therapeutic increases gut microbial diversity and prevents recurrent Clostridium difficile infection, Journal of Infectious Disease, 2016.

Note:  The C Diff Foundation does not endorse this product, or any product, and shares this article strictly for informational purposes.

 

 

C. diff. Spores and More Global Broadcasting Network Welcome Guests; Dr. David Cook, Ph.D., and Dr. Michele Trucksis, Ph.D., M.D. Of Seres Therapeutics, Inc.

“Ecobiotics: A Novel Approach to Recurrent C. difficile infections”

Tuesday, February 23rd — Live Broadcast

PODCAST IS NOW AVAILABLE, PLEASE CLICK ON THE SERES THERAPEUTICS LOGO BELOW

10 a.m. Pacific Time,,   11 a.m. Mountain Time,
12 p.m. Central Time,    1 p.m. Eastern Time

We invite you to  listen to the live broadcast and archived programs by clicking on the
Cdiff radio logo displayed below:

This episode introduces Seres Therapeutics, a leading microbiome therapeutics company, which recently published in the Journal of Infectious Diseases positive results from an open-label Phase 1b/2 study of SER-109 for the treatment of patients with recurrent
C. difficile infections (CDI).  Seres Therapeutics is creating a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis.

TO LISTEN TO THIS EPISODE – PLEASE CLICK ON THE SERES THERAPEUTICS LOGO BELOW

New insights into the human microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, creating new possibilities for patients not served by current therapeutic approaches. Ecobiotics are ecological compositions of beneficial organisms that are designed to reestablish a healthy microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.

Join Guests;  
Dr. David Cook, Ph.D., Executive Vice President of R&D and Chief Scientific Officer
And
Dr. Michele (Shelley) Trucksis, Ph.D., M.D., Executive Vice President and Chief Medical Officer

As we discuss the microbiome, CDI, clinical studies SER-109, Probiotics, ECOSPOR, and much more

 

C. diff. Spores and More  Global Broadcasting Network –  producing educational programs dedicated to  C. difficile Infections and more —  brought to you by VoiceAmerica and sponsored by Clorox Healthcare

 

Seres Therapeutics Disclaimer:
“This interview will include forward-looking statements on Seres Therapeutics’ current expectations and projections about future events. These statements are based upon current beliefs, expectations and assumptions, and are subject to a number of important risks and uncertainties, including those set forth in Seres Therapeutics’ filings with the SEC, many of which are difficult to predict. Actual results may differ materially from such statements. The information included in this interview is provided only as of the date of this interview, and Seres Therapeutics undertakes no obligation to update any forward-looking statements stated in this interview on account of new information, future events, or otherwise, except as required by law. Seres Therapeutics has provided financial support to the C Diff Foundation.”