Tag Archives: C. difficile antibiotic clincial study

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-logo

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

July 5th Join C. diff. Spores and More With Dr. Garey and Dr. Vickers As We Discuss Summit Therapeutics: Ridinilazole, a Microbiome Preserving Antibiotic For the Treatment Of C. difficile Infection (CDI)

 

Listen to the live broadcast

on  July 5th,  2016

cdiffRadioLogoMarch2015CLICK ON THE LOGO TO BE REDIRECTED TO THE  LIVE BROADCAST PAGE

Listen in to the live broadcast at 10a PT,   11a MT,   12p CT,   1p ET     6p UK


C. diff. Spores and More,”™ Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:  

Summit Therapeutics: ridinilazole, a microbiome preserving antibiotic for the treatment of a C. difficile infection (CDI)

With Our Guests:

Dr. Kevin W. Garey; Chair, Department of Pharmacy Practice and Translational Research Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, TX

Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics

Join us as we discuss a promising and new treatment for a C. difficile infection.  Summit Therapeutic’s Ridinilazole, a microbiome preserving antibiotic will be introduced with updates with our  guests Dr. Kevin W. Garey, Chair, Department of Pharmacy Practice and Translational Research, Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, Texas and  Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics

♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦

C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

Programming for C. diff. Spores and More ™  is made possible through our official  Sponsor;  Clorox Healthcare

CloroxHealthcare_72

Summit Therapeutics PLC Is Granted A “Composition Of Matter” Patent By U.S. Patent and Trademark Office

In The News:

C. difficile Infection–  Treatment On The Horizon

Summit Therapeutics PLC

summit

The US patent and trademark office have granted a “composition of matter” patent.

It gives a period of exclusivity for ridinilazole in the United States until at least December 1, 2029, with the possibility of being extended.

It’s been a busy period for the firm and Glyn Edwards, Chief Executive said: “This new patent grant in one of our potential major commercial markets substantially strengthens our intellectual property estate protecting our novel CDI antibiotic ridinilazole and supports our efforts to maximize the potential of this promising compound.”

“We are focused on our CDI and DMD programmes and today’s news, combined with the recently announced expansion advancing  of our PhaseOut DMD trial, highlights their continuing excellent progress as we seek to have a meaningful impact on the lives of patients living with these serious diseases.”

In a Phase 2 clinical trial, ridinilazole showed statistical superiority over vancomycin – the standard of care medicine –  in rates of sustained clinical response, an endpoint that captures both initial cure and recurrence of the disease.

 

To read article in its entirety:

http://www.proactiveinvestors.co.uk/companies/news/125364/summit-therapeutics-plc-boosted-by-us-patent-for-c-diff-antibiotic-125364.html

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

Summit Therapeutics To Present Further Data Showing Superiority Of Its New Antibiotic At the 26th ECCMID Conference

summit

 

 

Summit Therapeutics is to present further data showing the superiority of its new antibiotic for hospital superbug C.diff. over the standard of care medicine.

The additional data on Summit’s ridinilazole versus vancomycin comes from the from the Phase 2 CoDIFy trial and will be heard at the 26th European Congress of Clinical Microbiology and Infectious Diseases Conference  (ECCMID).

(ECCMID 2016  Will be hosted in Amsterdam from 9 – 12 April )

Taking the antibiotic ridinilazole resulted in a marked reduction in rates of C. diff. (CDI) recurrence as compared to vancomycin (14.3% versus 34.8%) the drug discovery firm will say.

This result comes on top of t previously reported statistical superiority in ‘sustained clinical response’ rates of ridinilazole over vancomycin (66.7% compared to 42.4%) for treating the disease.

Sustained clinical response is defined as clinical cure at the end of treatment and no recurrence of the condition in 30 days after therapy.

C. diff is a serious threat in hospitals and care homes and there are between 450000 and 700000 cases in the US annually.

Recurrence is a key problem as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

 

 

To read the total article, click on the following link:

http://www.menafn.com/1094678222/Summit-Therapeutics-to-present-further-data-showing-ridinilazoles-superiority

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.