Fecal microbiota transplant

Ferring Pharmaceuticals' 1st in Class C.diff Treatment, Rebyota, Experiences a Positive Early Launch Ahead of Potential Competition, According to Spherix Global Insights

Retrieved on: 
Friday, March 17, 2023

EXTON, Pa., March 17, 2023 /PRNewswire/ -- When the FDA approved Rebyota, a new class of Clostridioides Difficile (C.diff) treatment, Ferring Pharmaceuticals ushered in the first significant breakthrough doctors treating the disease have seen in years. Rebyota falls in the class of therapy known as Fecal Microbiota Transplant, or FMT, a therapy over 60% of treating gastroenterologists believe will dramatically change the paradigm of C.diff treatment in the next five years, according to research from Spherix Global Insights Market Dynamix™ Clostridioides Difficile (US) service.

Key Points: 
  • At least two additional FMT treatments are in development for C.diff, including Aimmune/Seres' SER-109 and Vedanta Biosciences' VE303.
  • With a first to market advantage, Ferring's Rebyota has seen early positive adoption from gastroenterologists and infectious disease specialist in the first month post-launch.
  • As part of their Launch Dynamix™: C.diff service, Spherix reports, while new monthly initiations are modest, a majority of physicians trialing Rebyota report high satisfaction.
  • A few headwinds Ferring may be facing with Rebyota include its mode of administration, and storage and handling requirements.

Microbiome Global Market Report 2022: 26% Annual Growth Driven by Key Players AbbVie, Seres, Enterome & Others - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 30, 2022

The "Microbiome Global Market Report 2022, Type, Application, Technology" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Microbiome Global Market Report 2022, Type, Application, Technology" report has been added to ResearchAndMarkets.com's offering.
  • The increasing prevalence of inflammatory bowel disease (IBD) is a key factor driving the growth of the microbiome market.
  • Therefore, the increasing prevalence of inflammatory bowel disease (IBD) is expected to drive the growth of the microbiome market.
  • The high cost of microbial therapy is a key factor hampering the growth of the microbiome market.

Microbiome Global (FMT, Microbiome Drugs) Market Report 2022 Featuring Major Players - MicroBiome Therapeutics; Seres Therapeutics; Enterome Bioscience; Second Genome; Vedanta Biosciences - ResearchAndMarkets.com

Retrieved on: 
Friday, June 17, 2022

The "Microbiome Global Market Report 2022: By Type, By Application, By Technology" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Microbiome Global Market Report 2022: By Type, By Application, By Technology" report has been added to ResearchAndMarkets.com's offering.
  • The different technologies include genomics, proteomics, metabolomics and is used in inflammatory bowel disease, diabetes, multiple sclerosis, rheumatoid arthritis, others.
  • The increasing prevalence of inflammatory bowel disease (IBD) is a key factor driving the growth of the microbiome market.
  • Therefore, the increasing prevalence of inflammatory bowel disease (IBD) is expected to drive the growth of the microbiome market.

Global Microbiome Markets Report 2021-2030: Focus on Fecal Microbiota Transplantation (FMT) & Microbiome Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 16, 2021

The "Microbiome Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Microbiome Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.
  • Microbiome Global Market Report 2021: COVID-19 Growth and Change to 2030 provides the strategists, marketers and senior management with the critical information they need to assess the global microbiome market.
  • The microbiome market covered in this report is segmented by type into fecal microbiota transplantation (FMT); microbiome drugs and by application into inflammatory bowel disease; diabetes; multiple sclerosis; rheumatoid arthritis; others.
  • Therefore, the increasing prevalence of inflammatory bowel disease (IBD) is expected to drive the growth of the microbiome market.

Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance)

Retrieved on: 
Monday, March 15, 2021

Transplant recipients receiving maribavir exhibited lower incidence of treatment-related toxicities common with conventional antiviral therapies.

Key Points: 
  • Transplant recipients receiving maribavir exhibited lower incidence of treatment-related toxicities common with conventional antiviral therapies.
  • The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.
  • Duarte R. Maribavir Versus Investigator-Assigned Therapy for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus Infection: Efficacy Data From a Randomized Phase 3 Open-Label Study.
  • Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials.

Global GI Stool Testing Markets, 2020-2025: Growth, Trends, and Forecasts - Rising Demand for Point of Care Tests Expected to Fuel Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 3, 2020

The increasing burden of diseases related to the gastrointestinal tract and rising demand for point of care tests is expected to fuel the GI stool testing market growth.

Key Points: 
  • The increasing burden of diseases related to the gastrointestinal tract and rising demand for point of care tests is expected to fuel the GI stool testing market growth.
  • Thus, this factor can increase the demand for GI stool testing to detect bacteria and parasites.
  • Furthermore, the rising prevalence of diarrhea is expected to raise the demand for reagents in the GI stool testing market.
  • Collaborations, mergers, and acquisitions by companies related to GI stool testing are expected to boost the market growth.

Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive SER-109 Phase 3 Study Results

Retrieved on: 
Friday, September 11, 2020

After obtaining highly statistically significant topline Phase 3 ECOSPOR III SER-109 study results in recurrent CDI, Seres requested a Breakthrough Therapy Designation meeting with the FDA.

Key Points: 
  • After obtaining highly statistically significant topline Phase 3 ECOSPOR III SER-109 study results in recurrent CDI, Seres requested a Breakthrough Therapy Designation meeting with the FDA.
  • Seres is taking various measures to expedite open-label study enrollment, including increasing the number of SER-109 clinical study sites across the U.S. and Canada.
  • Seres also anticipates that the quarantine of material used for unapproved Fecal Microbiota Transplantation (FMT) by a national provider will accelerate SER-109 open-label study enrollment.
  • Seres SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA.

Seres Therapeutics Issues Statement Regarding U.S. Food and Drug Administration’s March 12, 2020 Safety Alert Related to Use of Fecal Microbiota Transplantation

Retrieved on: 
Friday, March 13, 2020

Seres Therapeutics, Inc. (Nasdaq: MCRB) today provided a statement on a safety alert from the U.S. Food and Drug Administration (FDA) regarding bloodstream infections with multi-drug resistant organisms (MDROs) transmitted through fecal microbiota transplantation (FMT).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB) today provided a statement on a safety alert from the U.S. Food and Drug Administration (FDA) regarding bloodstream infections with multi-drug resistant organisms (MDROs) transmitted through fecal microbiota transplantation (FMT).
  • SER-109 is manufactured under Good Manufacturing Practices (GMP) conditions and is quality-controlled using stringent standards to ensure product quality and consistency.
  • Seres believes that donor and product screening are necessary but insufficient to minimize infection risk for donor-derived microbiome and FMT products.
  • Seres is also developing SER-401 in a Phase 1b study in patients with metastatic melanoma and SER-301 for ulcerative colitis.

Enrolment of first patient in Phase II trial testing DNV3837 in Clostridioides difficile infections

Retrieved on: 
Monday, January 27, 2020

The Phase II clinical trial aims to evaluate the efficacy, safety and pharmacokinetics of DNV3837 in patients with Clostridioides difficile gastrointestinal infection (CDI).

Key Points: 
  • The Phase II clinical trial aims to evaluate the efficacy, safety and pharmacokinetics of DNV3837 in patients with Clostridioides difficile gastrointestinal infection (CDI).
  • DNV3837 targets the treatment of Clostridioides difficile infections (CDI), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections1.
  • The Phase II trial aims to evaluate the efficacy of DNV3837 in pathological conditions (through monitoring of symptoms, stool analysis, etc.
  • "The start of this Phase II clinical trial is a significant step forward for DEINOVE and a great hope for patients.

Pitt Hopkins Research Foundation Announces First-ever Human Clinical Trial: Eradicating Gastrointestinal Challenges Through Microbiota Transfer Therapy

Retrieved on: 
Tuesday, October 1, 2019

In partnership with Arizona State University's (ASU) Autism/Asperger's Research Program, a trial is scheduled to begin early 2020 focused on Microbiota Transfer Therapy (MTT), also known as a fecal microbiota transplant.

Key Points: 
  • In partnership with Arizona State University's (ASU) Autism/Asperger's Research Program, a trial is scheduled to begin early 2020 focused on Microbiota Transfer Therapy (MTT), also known as a fecal microbiota transplant.
  • "This trial is a huge milestone for our young foundation," said Audrey Davidow Lapidus, president of the Pitt Hopkins Research Foundation.
  • "Not only do we hope the trial will bring relief for our children, it signals the continued growth of the Pitt Hopkins Research Foundation as a serious player in the medical research field."
  • About the Pitt Hopkins Research Foundation: Since 2013, the Pitt Hopkins Research Foundation (PHRF) has supported research dedicated to finding a treatment, and an eventual cure of PTHS and other similar disorders.