Clostridioides difficile infection

FDA Approves First Fecal Microbiota Product

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Wednesday, November 30, 2022
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SILVER SPRING, Md., Nov. 30, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI.

Key Points: 
  • SILVER SPRING, Md., Nov. 30, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency.
  • As the first FDA-approved fecal microbiota product, today's action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI."
  • The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.
  • In addition, Rebyota may contain food allergens; the potential for the product to cause adverse reactions due to food allergens is unknown.

Global Microbiome Therapeutics Market Report 2022: Mergers and Collaborations Continue to Boost Brand New Industry - ResearchAndMarkets.com

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Monday, November 28, 2022
Health, Biotechnology, Growth, AstraZeneca, Clostridioides difficile infection, AbbVie, Phenylketonuria, Attention, Organization, Prevalence, CDI, Partnership, Biotechnology, Hepatic encephalopathy, Government, USD, Crohn's disease, Disease, Cancer, Research, Diabetes, Therapy, Federation, Inflammatory bowel disease, Immunotherapy, Drug discovery, FMT, Pharmaceutical industry, Application

The "Global Microbiome Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2017-2027 Segmented By Type (FMT v/s Microbiome Drugs), By Application (C. Difficile, Crohn's Disease, Inflammatory Bowel Disease, Diabetes, Others), By Region" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Microbiome Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2017-2027 Segmented By Type (FMT v/s Microbiome Drugs), By Application (C. Difficile, Crohn's Disease, Inflammatory Bowel Disease, Diabetes, Others), By Region" report has been added to ResearchAndMarkets.com's offering.
  • The global microbiome therapeutics market is anticipated to witness an impressive growth during the forecast period, 2023-2027.
  • This in turn is expected to drive the growth of global microbiome therapeutics market during the forecast period.
  • According to clinicaltrials.gov, there are around 188 clinical trials registered on its portal related to microbiome therapeutics.

SAB Biotherapeutics Initiates IND-Enabling GLP Toxicology Study for SAB-142, Novel Immunotherapeutic for Type 1 Diabetes

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Monday, November 21, 2022
Autoimmune disease, Degenerative disease, SAB, Type 1, IND, Anaphylaxis, Patient, Mortality, Government, Toxicity, Genetic engineering, Pandemic, Clostridioides difficile infection, GLP, File, MD, Diabetes, Patent, Annual report, Infection, Serum sickness, Health, Therapy, Type, United States Department of Defense, Immunotherapy, Form 10-K, FDA, Probability, Vaccine, Pharmaceutical industry, T1D

In an IND-enabling GLP study, SAB-142 will be compared to an FDA-approved T-cell depleting therapeutic, to assess toxicity and pharmacodynamic effects.

Key Points: 
  • In an IND-enabling GLP study, SAB-142 will be compared to an FDA-approved T-cell depleting therapeutic, to assess toxicity and pharmacodynamic effects.
  • Type 1 diabetes is an autoimmune disease that represents a staggering unmet patient need, said Alexandra Kropotova, MD, Chief Medical Officer of SAB Biotherapeutics.
  • Patients in the Americas are disproportionally affected by Type 1 diabetes.
  • The initiation of this study supports the progression of our SAB-142 immunotherapeutic towards IND filing.

SAB Biotherapeutics Provides Company Update for Q3 2022 Financial Results

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Tuesday, November 15, 2022
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SIOUX FALLS, S.D., Nov. 15, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today reported financial results for the third quarter ended September 30, 2022, and provided a company update.

Key Points: 
  • SIOUX FALLS, S.D., Nov. 15, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today reported financial results for the third quarter ended September 30, 2022, and provided a company update.
  • The SAB fully-human polyclonal antibody platform maintains its efficacy against multiple variants of several highly mutating viruses.
  • Financial Guidance: SAB received $8.6 million from the DoD contract on November 10, 2022, for work performed.
  • SAB Biotherapeutics, Inc. (SAB) We are a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders.

Seres Therapeutics to Host Investor Webcast on December 8, 2022 to Discuss SER-109 Commercial Strategy

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Tuesday, November 22, 2022
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Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it will host an investor webcast to discuss the planned commercialization approach and market opportunity for therapeutic candidate SER-109 in recurrent C. difficile infection (rCDI) on Thursday, December 8, 2022, at 8:30 a.m.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it will host an investor webcast to discuss the planned commercialization approach and market opportunity for therapeutic candidate SER-109 in recurrent C. difficile infection (rCDI) on Thursday, December 8, 2022, at 8:30 a.m.
  • The SER-109 investor webcast will include members of management from Seres Therapeutics, Aimmune Therapeutics, Inc., a Nestl Health Science Company, as well as Carl Crawford M.D.
  • To join the live webcast, please visit the Investors and News section of the Seres website at www.serestherapeutics.com .
  • Seres Therapeutics, Inc. (Nasdaq: MCRB) is a leading microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.

CHOP-led Study Shows that Antibiotic-Resistant Microbes in the Gut Make C. difficile More Infectious

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Wednesday, November 16, 2022
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PHILADELPHIA, Nov. 16, 2022 /PRNewswire/ -- Clostridioides difficile, often referred to as C. difficile or C. diff, is a bacterium that causes severe intestinal illness and, as its name suggests, can be difficult to study and treat. Approximately 1 in 6 patients infected with C. difficile will be reinfected within two months. Yet scientists have not figured out why C. difficile infection is more difficult to treat in some patients versus others. The human gut is filled with trillions of microbes, and these microbes influence the virulence of various pathogens, but until now, scientists had little understanding of how C. difficile cooperates with the rich collection of microorganisms in the gastrointestinal tract.

Key Points: 
  • Yet scientists have not figured out why C. difficile infection is more difficult to treat in some patients versus others.
  • Prior studies have shown that adults infected with C. difficile also have high levels of Enterococcus in their gut and that vancomycin-resistant Enterococcus (VRE) frequently co-infects patients with C. difficile.
  • They also observed a positive correlation between C. difficile burdens and ornithine, supporting a key role for this amino acid in C. difficile infection.
  • difficile."

Finch Therapeutics Provides Corporate Updates and Reports Third Quarter 2022 Financial Results

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Thursday, November 10, 2022
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SOMERVILLE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (Finch or Finch Therapeutics) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs, today provided corporate updates and reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • SOMERVILLE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (Finch or Finch Therapeutics) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs, today provided corporate updates and reported financial results for the third quarter ended September 30, 2022.
  • Presented CP101 PRISM-EXT Biomarker Data at ACG 2022: In October 2022, Finch announced the presentation of biomarker data from the PRISM-EXT open-label trial of CP101 in recurrent CDI at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting.
  • Finch reported a net loss of $40.4 million for the third quarter of 2022, compared to a net loss of $10.0 million for the same period in 2021.
  • Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.

SAB Biotherapeutics Presents ‘Novel Biologic Therapeutics for Infectious Diseases’ at U.S. Pharma Partnering Summit 2022

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Tuesday, November 8, 2022
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The Pharma Partnering Summit brings together dealmakers of leading life science companies to disseminate knowledge through expert speakers and help large, mid-sized and small pharma and biotech companies expand their network, establish deals, and develop their business.

Key Points: 
  • The Pharma Partnering Summit brings together dealmakers of leading life science companies to disseminate knowledge through expert speakers and help large, mid-sized and small pharma and biotech companies expand their network, establish deals, and develop their business.
  • SABs presentation, titled Novel Biologic Therapeutics for Infectious Diseases, will take place on Thursday, Nov. 17 at 12:25 pm ET.
  • SAB Biotherapeutics, Inc. (SAB) We are a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders.
  • Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients.

Vedanta Biosciences to Present at the 9th International Human Microbiome Consortium Congress

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Wednesday, November 9, 2022
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Vedanta Biosciences , a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced that Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences, will present at the 9th International Human Microbiome Consortium Congress (IHMC), being held from November 8 10, 2022 in Kobe, Japan.

Key Points: 
  • Vedanta Biosciences , a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced that Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences, will present at the 9th International Human Microbiome Consortium Congress (IHMC), being held from November 8 10, 2022 in Kobe, Japan.
  • The presentation will include results of the Phase 2 CONSORTIUM study of VE303 in Clostridioides difficile infection (CDI).
  • VE303 is a defined bacterial consortium therapeutic candidate designed for the prevention of recurrent Clostridioides difficile infection (rCDI).
  • Vedanta Biosciences controls a foundational portfolio of more than 60 patents and has built what it believes is one of the largest libraries of bacteria derived from the human microbiome.

BiomeBank Announces World First Regulatory Approval for Donor Derived Microbiome Drug

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Wednesday, November 9, 2022
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Therapeutic Goods Administration, Solution, TGA, Therapy, Clostridioides difficile infection, Machine learning, Disease, Diarrhea, Ecology, Microbiology, Pharmaceutical industry, Antibiotics

BiomeBank today announced the first regulatory approval for a donor derived microbiome drug product worldwide.

Key Points: 
  • BiomeBank today announced the first regulatory approval for a donor derived microbiome drug product worldwide.
  • C.difficile infection is the most common cause of health care associated diarrhoea, a debilitating condition with significant global unmet medical need.
  • BiomeBank's Co-founder and Managing Director Dr Sam Costello said, "This approval is a landmark for BiomeBank and an important advance for microbiome therapeutics globally.
  • We are thrilled to achieve market authorisation and intend to scale manufacturing of our donor derived microbiome drug product to meet the immediate medical need.