Tag Archives: Clostridium difficile clinical studies

U.S. Food and Drug Administration (FDA) Has Accepted 2 New Drug Applications (NDA) for DIFICID (fidaxomicin) In Children Aged Six Months Or Older

OCTOBER 2019

Merck

Known as MSD outside the United States and Canada

announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for DIFICID ® (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides ) difficile infections (CDI) in children aged six months or older. Both applications have received a priority review classification by the FDA. The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020. The investigational pediatric indication for DIFICID was granted Orphan Drug Designation (ODD) in 2010.

“Evidence indicates the increasing incidence of C. difficile -associated diarrhea among hospitalized children 1,” said Dr. Nicholas Kartsonis, senior vice president, Clinical Research, infectious diseases and vaccines, Merck Research Laboratories. “The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for DIFICID tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs.”

The sNDA is based primarily on results of the Phase 3 SUNSHINE study 2, which were presented as part of the Late Breaker Oral Abstracts on Emerging Infections at IDWeek 2018 in San Francisco, California.

About DIFICID (fidaxomicin)

DIFICID is a macrolide antibacterial medicine indicated in adults (18 years of age or older) for treatment of Clostridium difficile -associated diarrhea (CDAD). To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridiumdifficile. DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID. DIFICID should only be used for the treatment of C. difficile-associated diarrhea. DIFICID is not effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin.

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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

Summit Therapeutics plc Outlines Phase 3 Program for Novel C. difficile Infection Antibiotic Ridinilazole

summit

Clostridium difficile Treatment – Phase 3 program outline —

 

SUMMIT OUTLINES PHASE 3 PROGRAMME FOR NOVEL CDI ANTIBIOTIC RIDINILAZOLE FOLLOWING FDA AND EMA REGULATORY MEETINGS

Oxford, UK, On 1 February 2017 – Summit Therapeutics plc
the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’),  outlines its Phase 3 programme for its novel antibiotic, ridinilazole, following recent regulatory meetings with the US Food and Drug Administration (‘FDA’) and European Medicines Agency (‘EMA’).

With input from the FDA and EMA, Summit intends to design the Phase 3 clinical programme to evaluate superiority of ridinilazole over standard of care in the treatment of C. diffiicle Infection (CDI).

A positive Phase 3 result on superiority has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial CDI and reduce disease recurrence.

Mr Glyn Edwards, Chief Executive Officer of Summit commented: “The constructive end of Phase 2 meetings with the US and European regulators have enabled us to design a Phase 3 programme that focuses on evaluating ridinilazole’s superiority over standard of care. This is something we believe would help differentiate our novel class antibiotic from currently marketed CDI treatments and those in late-stage development. Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of CDI.”
Summit discussed its Phase 3 development programme with the FDA at an End of Phase 2 meeting and through a scientific advice process with EMA. With input from both agencies, the Phase 3 programme is expected to include two trials evaluating ridinilazole as compared to the standard of care, vancomycin, each of which would enrol approximately 700 patients with CDI with the primary endpoint being superiority in sustained clinical response (‘SCR’). Other planned endpoints will include health economic outcome measures. The Phase 3 trial designs are consistent with the successful proof of concept Phase 2 trial, CoDIFy, in which ridinilazole achieved statistical superiority over vancomycin in SCR. SCR is a combined endpoint that measures cure at the end of treatment and a lack of recurrence in the 30 days after treatment. FDA also confirmed that ridinilazole would be eligible for Priority Review based on its QIDP designation.
Mr Edwards continued: “As we continue to evaluate our options to maximize the value of ridinilazole, our stronger financial position following the DMD programme partnership with Sarepta Therapeutics, Inc. means Summit has more time to fully explore all options. These include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government and charitable organizations. In parallel, activities

About Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI.

In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection.

Resources:

http://www.summitplc.com/media/press-releases/

Rebiotix Is Issued U.S. Patent For Its Patent Application Entitled “Microbiota Restoration Therapy (MRT) Compositions and Methods Of Manufacture”

Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases,  announced on October 11, 2016 that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,433,651 to Rebiotix for its patent application entitled, “Microbiota Restoration Therapy (MRT), Compositions and Methods of Manufacture.” The patent covers Microbiota Restoration Therapy (MRT) compositions and methods for manufacturing, processing and delivering the compositions, and builds on Rebiotix’s patent issuances in Australia and Canada.

MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a readyto-use and easy-to-administer format. The patented technology is based on ground-breaking work that provides an avenue for the treatment of a variety of diseases including Clostridium difficile (C.diff), ulcerative colitis, hepatic encephalopathy and multi-drug resistant organisms.

“This patent covering our MRT platform is a significant addition to Rebiotix’s IP estate as we continue to advance our industry-leading pipeline of microbiome-directed drug therapies, including RBX2660, our Phase 3-ready drug candidate,” stated Lee Jones, Chief Executive Officer of Rebiotix. “Rebiotix has established one of the deepest IP portfolios in the microbiome industry covering an array of subjects, from formulation and storage to delivery and disease targets, that we believe are key to the eventual commercialization of microbiota-based therapeutics.”

https://cdifffoundation.org/clinical-trials-2/

 

About Rebiotix Inc.

Rebiotix Inc. is a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically advanced microbiome company in the industry, with its Phase 3-ready drug candidate, RBX2660, having successfully completed a Phase 2b randomized, double-blind, placebo controlled trial as a potential treatment for recurrent Clostridium difficile infection (PUNCH™ CD2). RBX2660 has been granted Orphan Drug status, Fast Track status and Breakthrough Therapy Designation from the FDA for its potential to treat recurrent C. diff. infection.

Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around its pioneering Microbiota Restoration Therapy (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

source:  Rebiotix

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.

 

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