Tag Archives: ECOSPOR III

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 Announces a New SER-109 Phase 2 Clinical Study (ECOSPOR III) For Patients With Multiple Recurrent C. diff. Infections (CDI’s)

Seres Therapeutics Inc. a leading microbiome therapeutics platform company, announced on March 16th, 2017 plans to initiate a new SER-109 Phase 2 clinical study (ECOSPOR III) in patients with multiply recurrent Clostridium difficile (C. difficile) infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the U.S. Food and Drug Administration (FDA). In a separate announcement today, Seres reported fourth quarter and full year 2016 financial results and provided an update on multiple ongoing microbiome clinical programs.

Seres plans to initiate a new SER-109 clinical study in approximately 320 patients with multiply recurrent C. difficile infection. Study participants will be randomized 1:1 between SER-109 and placebo. To ensure accurate measurement of C. difficile infection, diagnosis of recurrent C. difficile infection for both study entry and for endpoint analysis will be confirmed by C. difficile cytotoxin assay. Patients in the SER-109 arm will receive a total SER-109 dose, administered over three days, approximately 10-fold higher than the dose used in the prior ECOSPOR study. ECOSPOR III will evaluate patients for 24 weeks and the primary endpoint will compare the C. difficile recurrence rate in subjects who receive SER-109 verses placebo at up to eight weeks after dosing. The FDA has agreed that this new trial may qualify as a pivotal study with achievement of a persuasive clinical effect and addressing FDA requirements, including clinical and statistical factors, an adequately sized safety database, and certain CMC parameters.

“We are pleased to have received highly constructive guidance from the FDA regarding further SER-109 clinical development and we plan to initiate a new clinical study as soon as possible,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. “Our prior SER-109 studies provided important new biological and clinical data that have advanced our pioneering microbiome therapeutic efforts. Based on our learnings and dialogue with the FDA, we believe that we are now positioned to initiate a robust clinical study that may provide the basis for SER-109 approval. There is an urgent need for improved treatments for C. difficile infection, and we believe SER-109 has great potential to address the underlying cause of the disease and become the first approved microbiome therapeutic in this new field of medicine.”

About SER-109

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.

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. The Phase 2 study of Seres’ program SER-109 has been completed in multiply recurrent Clostridium difficile infection. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC). Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary CDI. For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.

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 without limitation statements regarding SER-109 development plans, the timing, design, and results of the ECOSPOR III study , the potential for ECOSPOR III to provide different results than the previous ECOSPOR study, the impact analysis of prior clinical studies may have on clinical outcomes, the potential for ECOSPOR III to qualify as a Pivotal Study, dysbiosis as an underlying cause of C. difficile and other diseases.

To Read article in its entirety please click on the link below:

http://finance.yahoo.com/news/seres-therapeutics-initiate-ser-109-110000650.html;_ylt=AwrBT.EHTNBYMRUAv3hXNyoA;_ylu=X3oDMTEzbjcwdjAxBGNvbG8DYmYxBHBvcwM4BHZ0aWQDVUkwMkM0XzEEc2VjA3Ny