Tag Archives: SER-109

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)

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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

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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

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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.”

Seres Therapeutics, Inc., A Leading Microbiome Therapeutics Company, Announced Positive Results From the Phase 1b/2 Study of SER-109 In Recurrent Clostridium difficile infections (CDI)

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“The impressive level of efficacy observed with SER-109 treatment is striking when compared with the high rate of recurrence expected in this population,” said Dr. Stuart H. Cohen, MD, Chief, Division of Infectious Diseases, University of California, Davis. “These results demonstrate the potential of SER-109 to effectively treat recurrent CDI. With current treatment approaches having significant limitations, SER-109 has the potential to fundamentally change the management of this urgent health issue.”

Abstract

Background. Patients with recurrent Clostridium difficile infection (CDI) have a ≥60% risk of relapse, as conventional therapies do not address the underlying gastrointestinal dysbiosis. This exploratory study evaluated the safety and efficacy of bacterial spores for preventing recurrent CDI.

Methods.  Stool specimens from healthy donors were treated with ethanol to eliminate pathogens. The resulting spores were fractionated and encapsulated for oral delivery as SER-109. Following their response to standard-of-care antibiotics, patients in cohort 1 were treated with SER-109 on 2 consecutive days (geometric mean dose, 1.7 × 109 spores), and those in cohort 2 were treated on 1 day (geometric mean dose, 1.1 × 108 spores). The primary efficacy end point was absence of C. difficile–positive diarrhea during an 8-week follow-up period. Microbiome alterations were assessed.

Results.  Thirty patients (median age, 66.5 years; 67% female) were enrolled, and 26 (86.7%) met the primary efficacy end point. Three patients with early, self-limiting C. difficile–positive diarrhea did not require antibiotics and tested negative for C. difficile at 8 weeks; thus, 96.7% (29 of 30) achieved clinical resolution. In parallel, gut microbiota rapidly diversified, with durable engraftment of spores and no outgrowth of non–spore-forming bacteria found after SER-109 treatment. Adverse events included mild diarrhea, abdominal pain, and nausea.

Conclusions.  SER-109 successfully prevented CDI and had a favorable safety profile, supporting a novel microbiome-based intervention as a potential therapy for recurrent CDI.

 

Clostridium difficile infection (CDI) and its attendant complications, including diarrhea, pseudomembranous colitis, and toxic megacolon, are associated with an estimated 29 000 annual deaths in the United States and is recognized by the Centers for Disease Control and Prevention as an urgent public health priority [1]. Antibiotic exposure is the leading risk factor for CDI, and the risk of recurrent disease is increased among elderly patients and following antibiotic reexposure. Antibiotic therapy for recurrent CDI contributes to persistent disruption of the gut microbiome, which is the first-line defense against colonization and infection by pathogens, including C. difficile [25]. The risk of recurrence increases to >60% following a second episode [3, 6, 7].

Research has focused on the potential role that the human microbiome plays in health and disease. In 2008, the National Institutes of Health supported the creation of the Human Microbiome Project to characterize the species composition and function of the healthy microbiome. In the gut, the 2 dominant phyla are Firmicutes (ie, gram-positive organisms, including Bacilli and Clostridia) and Bacteroidetes (ie, gram-negative anaerobes, including Bacteroides, Parabacteroides, and Prevotella) [8, 9]. In contrast, gram-negative Enterobacteriaceae, such as Escherichia coli, make up only a fraction of the healthy microbiome [8]. There is also significant intersubject variability at both the genus and species level, suggesting that the bacterial communities in any one individual are unique, mirroring the complex interplay of diet, host genetics, immune response, and microbial coadaptation. Despite this variation, there are common core species found in a majority of healthy individuals, and metabolic pathways are preserved due to functional redundancy [10]. Thus, a wide range of microbiomes defines a healthy state.

In states of disease, there are also broad patterns that define gut dysbiosis, such as a loss of microbial diversity and increasing representation of gram-negative facultative anaerobes, such as Enterobacteriaceae [11, 12]. Antibiotic-induced dysbiosis underlies colonization and invasion by C. difficile, while repair of the microbiome, through fecal microbiota transplantation (FMT), is associated with efficacy rates of 81%–90% for those with recurrent CDI [1316]. FMT involves transferring minimally processed, uncharacterized fecal material from a healthy donor to a recipient [17].

FMT administration is often invasive and requires donor screening and stool preparation. Despite donor screening, stool preparations for FMT have the potential to transmit infections due to pathogens that are present at times outside the period of detectability or for which diagnostic tests are unavailable; there is also the possibility of unwitting transmission of emerging pathogens that have not been identified to date [18, 19]. While there have been recent reports of stool delivered via oral encapsulated FMT or stool enemas, the data demonstrate first-dose efficacy of approximately 52%–70%, which is significantly lower than that for other modes of administration, such as colonoscopy [14, 20, 21]. In recognition of FMT as an experimental biologic, the Food and Drug Administration issued guidance that this intervention should only be used for prevention of recurrent CDI and after receipt of informed consent. An alternative approach for achieving improved safety and convenience with comparable efficacy is urgently needed [22].

SER-109 is composed of approximately 50 species of Firmicutes spores derived from stool specimens from healthy donors. After demonstrating the preclinical efficacy of SER-109 in rodent CDI models, we formulated it for oral delivery in humans based on the hypothesis that spore-forming organisms would compete metabolically with C. difficile for essential nutrients and/or bile acids [2327]. In addition, spore purification with ethanol reduces the risk of transmission of other potential pathogens [28]. This initial study was designed to evaluate the efficacy and safety profile of SER-109 for CDI prevention in patients with recurrent infections and to measure alterations in the gut microbiota.

METHODS

Study Design

This open-label, single-arm, descending-dose study evaluated the safety, efficacy, and engraftment of SER-109 formulated for oral delivery. The study was sponsored by Seres Therapeutics and conducted at 4 US medical centers: Massachusetts General Hospital (Boston, Massachusetts), Mayo Clinic (Rochester, Minnesota), Miriam Hospital (Providence, Rhode Island), and Emory University Hospital (Atlanta, Georgia). The protocol was developed by investigators at Seres Therapeutics and authors of the current study (E. L. H., D. S. P., and S. K.) and was approved by the institutional review boards of the participating medical centers.

Study Population

Eligible patients were 18–90 years old and had ≥3 laboratory-confirmed CDI episodes in the previous 12 months, had a life expectancy of ≥3 months, and gave informed consent to receive this donor-derived product. Patients were excluded for a history of acute leukemia; hematopoietic stem cell transplantation, chemotherapy within 2 months and an absolute neutrophil count of <1000 neutrophils/mm3, a history of inflammatory or irritable bowel disease, colectomy, cirrhosis, pregnancy/lactation, severe acute illness unrelated to CDI, antibiotic exposure for a non-CDI indication within 14 days of screening, or prior FMT.

Eligible patients had a clinical response to antibiotic therapy for their current CDI episode immediately prior to dosing and were neither anticipated to require admission to an intensive care unit nor expected to need antibiotics within 6 weeks following study entry.

Screening of Donors

Seven adult donors of stool specimens gave informed consent, underwent a complete medical history and laboratory assessment, and were screened for blood-borne and fecal pathogens, consistent with published protocols [29, 30]. Donors were excluded for being older than 50 years, having a body mass index (BMI; calculated as the weight in kilograms divided by the height in meters squared) of >25, engaging in high-risk behaviors as per a modified American Association of Blood Banks blood donor questionnaire [31], having a history of acute/chronic gastrointestinal disorders, or using antibiotics (in the previous 6 months), immunosuppressive/antineoplastic agents, or cigarettes (Supplementary Materials).

Preparation of SER-109

SER-109 comprises Firmicutes spores fractionated from stool specimens obtained from healthy donors. Donor stool specimens were processed separately to make unique batches of SER-109. Upon collection, stool specimens were frozen at −80°C. Approximately 150 g was suspended and homogenized in normal saline and filtered through mesh screens. The slurry was centrifuged, and supernatant containing bacterial cells and spores was combined with 100% ethanol to 50% (wt/wt) and incubated at room temperature for 1 hour to reduce risk of pathogen transmission to the recipient [28]. The supernatant was pelleted by centrifugation, washed with saline to remove ethanol, resuspended with sterile glycerol, and filled into capsules (hypromellose DRcaps, Capsugel), which were stored at −80°C.

The product was characterized for spore concentration and absence of residual gram-negative bacteria. Spore content was determined by measuring the dipicolinic acid (DPA) content and normalizing against the DPA content of known numbers of spores representing 3 commensal species [32]. The absence of residual gram-negative bacteria was confirmed by selective plating on MacConkey lactose agar and Bacteroides bile esculin agar. No vegetative microbes were found in any SER-109 preparation within the limit of assay detection (<30 colony-forming units/mL).

Treatment Protocol

Two days prior to dosing, patients discontinued antibiotics for CDI. One day prior to dosing, patients underwent a bowel preparation (to minimize residual antibiotic in the gastrointestinal tract), followed by overnight fasting. Two sites used a regimen of 300 mL of magnesium-citrate (one with Dulcolax), and 2 sites used polyethylene glycol.

Part 1 enrolled 15 patients who each received 30 capsules of SER-109 (observed dose of 15 capsules on day 0 and day 1). The dose of spores varied between 3 × 107 and 2 × 1010, based on natural variations in spore concentration among healthy donors. Based on initial efficacy, 15 additional patients were enrolled in part 2 and treated with SER-109 capsules containing a lower fixed dose of 1 × 108 spores (approximately 17-fold lower than the geometric mean dose administered in part 1 and 3-fold above the minimum dose shown to be effective). Depending on spore content, patients received an observed dose of 1–12 capsules on day 0.

Any patient whose diarrhea recurred between 1 and 8 weeks was eligible for another dose of SER-109, based on data from the conventional FMT literature showing efficacy of a second dose [13, 14]. If a patient elected to receive a second dose of SER-109, the time course of study events was restarted concurrent with the second dose of SER-109.

Adverse events and recurrence of CDI symptoms were monitored through phone calls (on day 4 and weeks 1, 2, and 4) and in-clinic visits (on weeks 8 and 24). Patients were asked to provide a stool sample on day 4 and on weeks 1, 2, 4, 8, and 24 after treatment for genomic and culture-based analysis.

Clinical Outcomes

The primary end point was prevention of recurrent CDI during the 8-week follow-up after SER-109. CDI recurrence was defined as a composite end point of >3 unformed bowel movements in a 24-hour period and laboratory confirmation of C. difficile in the stool. Safety was evaluated by monitoring adverse events and assessing changes in laboratory values, vital signs, and physical examination findings over a 24-week period after dosing.

Alterations in Gut Microbiota Composition

The impact of SER-109 on gut microbiota was determined by examining stool samples before and after treatment for (1) engraftment by spore-forming species and (2) augmentation (outgrowth) of commensal bacteria not found in SER-109. Alterations in composition were measured by 16S ribosomal RNA (rRNA) genomic and culture-based analysis of patient fecal samples (Supplementary Materials). Engraftment was defined by newly detected spore formers in the patient after treatment, which were present in SER-109 but not detectable in the patient before treatment. Augmented bacteria were defined as non–SER-109 organisms whose levels increased at least 10-fold after treatment.

RESULTS

Patient Population

Thirty patients were enrolled after therapeutic response to appropriate CDI antibiotics (ie, vancomycin [n = 23], fidaxomicin [n = 5], metronidazole [n = 1], and rifaximin [n = 1]) was documented (Table 1). Patients had a median age of 66.5 years (range, 22–88 years), and the majority of subjects (67%) were female. The median time from the initial C. difficile diagnosis to the most recent recurrence was 23.1 weeks in cohort 1 and 34.3 weeks in cohort 2. In the overall study population, the median number of CDI recurrences was 3 (range, 2–6 recurrences). Infecting C. difficile strains were identified in 10 patients and included types BI, Y, and DH (Supplementary Table 1).

View this table:

Table 1.

Patient Demographic Characteristics, by Cohort

Complete blood counts and a chemistry panel (including liver function tests and analysis of albumin and creatinine levels) were performed at week 8 (for 27 of 30 patients) and at week 24 or early termination for 20 of 30 patients. No significant changes in laboratory findings were observed, with the exception of those for 1 patient, who had an elevated white blood cell count at week 8 at the time of diagnosis of a urinary tract infection.

Clinical Outcomes

Of the 30 patients who received SER-109, 26 (86.7%) achieved the primary end point of no C. difficile–positive diarrhea up to 8 weeks following dosing, with similar outcomes in both dosing cohorts (Figure 1). Of the patients who met the primary end point, 1 required a second dose of SER-109 for recurrence of C. difficile–positive diarrhea on day 26, as per protocol. Four patients who did not meet the primary end point had early onset of symptoms at days 3, 5, 7, and 9 after administration of SER-109 and laboratory confirmation of C. difficile. One of these patients declined a second SER-109 dose and chose not to continue participating in the study. Notably, the other 3 patients were determined by their primary investigator to be recovering from a self-limiting diarrheal episode at the time of stool submission for C. difficile testing. In each case, the investigators advised the patients to refrain from antibiotic use, and all symptoms resolved without any therapeutic intervention; stool samples from these 3 patients were negative for C. difficile carriage at 8 weeks, using a sensitive nucleic acid amplification test for detection of toxins A and B. Thus, 29 of 30 patients (96.7%) achieved clinical resolution of recurrent CDI following SER-109 administration.

CdiffSeresTherapeuticsFig1

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Seres Therapeutics Focused On Developing Drugs To Treat Diseases Of The Microbiome With First Clinical Program ECOSPOR Research Study In The Treatment Of C. diff. Infection (CDI) And Now Open For Enrollment

seres_logo2_cmykSeres Therapeutics is a clinical-stage therapeutics company focused on discovering and developing drugs to treat diseases of the microbiome. The biology of the microbiome is driven by ecologies—the functional collections of various organisms—which are central to health and disease.

Seres is developing Ecobiotic® therapeutics to treat diseases that have an underlying microbiome biology. Seres Therapeutic’s first clinical program, The ECOSPOR Research study is in the treatment of Clostridium difficile  infection (CDI).
About The ECOSPOR Research Study

Although antibiotics are used to treat recurrent C. difficile infection, most of the time they do not cure C. difficile. In addition, antibiotics continue to wipe out the good bacteria that protect you against C. difficile. Currently, there are no medications available that can prevent this infection from coming back when your gut is defenseless.

SER-109 is an investigational medicine being developed to prevent recurrent C. difficile from coming back again. The idea is to first treat patients with antibiotics that work against C. difficile so that the diarrhea goes away. Then patients may get SER-109 to keep the C. difficile infection from coming back.

In the ECOSPOR study, doctors will compare SER-109 to a placebo pill, which looks like SER-109. However, the placebo pill will have no medication inside it. Patients will be randomly assigned to receive either SER-109 or placebo. The study is designed to provide more information about the potential safety and effectiveness of SER-109, and will last about 7 months. The results will help doctors and researchers learn whether SER-109 could one day be used to prevent recurrent CDI.

The ECOSPOR Study is now open for enrollment. If you would like more information the study is posted on ClinicalTrials.gov.

You can all contact clinicalstudies@sereshealth.com or by calling  1-617-945-9626  (USA) to find a doctor near you who is involved in the study.

 

 

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

C. diff. Infection Prevention Study: Phase 2 Study SER-109 by Seres Therapeutics; First Patient Dosed for the Prevention of Recurrent C. diff. Infection in Adults

* In The News *

Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, announced on May 28th, 2015 the enrollment and dosing of the first patient in its Phase 2 clinical study of SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (CDI) in adults.

The objective of the Phase 2 study is to further assess the efficacy and safety of SER-109, Seres’ leading development candidate.

“Recurrent CDI is a rapidly growing problem in the U.S., and antibiotics are currently the only FDA-approved treatment option,” said Roger Pomerantz, Chairman, President and CEO of Seres. “For many patients, antibiotics may exacerbate the problem by inducing or prolonging an imbalance of the microbiome and creating the conditions that support disease recurrence. We are excited about evaluating the potential of SER-109 to correct the microbiome and address this critical patient need.

“The start of our Phase 2 study is an important milestone for patients, and for Seres.

Our earlier studies suggest that SER-109 is a potentially transformative therapeutic for tens of thousands of patients each year, validating our conviction that treating dysbiosis of the microbiome enables us to address the underlying cause of disease and bring about rapid improvements in health.”

Results from the Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87 percent of patients met the primary study endpoint and 97 percent of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.

The Phase 2 study is a multicenter, randomized, placebo-controlled study that will evaluate the efficacy and safety of SER-109. The primary outcome measure is the absence of clinically-significant CDI through eight weeks following administration of SER-109 compared to placebo. SER-109 will be administered orally as a single dose, following the standard of care antibiotics for CDI. The study is actively enrolling and will be conducted at approximately 35 centers across the U.S. The read-out from the Phase 2 study is currently expected in the middle of 2016.

About SER-109

SER-109 is the lead Seres Ecobiotic® microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics™ platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to health. CDI is a rapidly growing problem associated with antibiotic use. Approximately 85,000 to 110,000 CDI patients in the U.S. are expected to have more than one recurrence.

About Seres Therapeutics, Inc.

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.

 

For article in its entirety:

http://finance.yahoo.com/news/seres-therapeutics-inc-announces-first-113000601.html

 

 

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