DelveInsight’s, “Clostridium Difficile Infections (Clostridium Difficile Associated Disease) Pipeline Insight, 2022” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in Clostridium Difficile Infections (Clostridium Difficile Associated Disease) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Key takeaways from the Clostridium Difficile Infections Pipeline Insight Report
- DelveInsight’s Clostridium Difficile Infections Pipeline report depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for Clostridium Difficile Infections treatment.
- The leading Clostridium Difficile Infections Pipeline Companies are working such as Rebiotix, Seres Therapeutics, Acurx Pharmaceuticals, Adiso Therapeutics, Summit Therapeutics, Finch Therapeutics Group, Mikrobiomik Healthcare Company S.L., Crestone, MGB Biopharma, Vedanta Biosciences, Inc., Deinove, Biovertis AG, Lumen Bioscience, and others.
- Promising Clostridium Difficile Infections Pipeline therapies such as Fidaxomicin, DAV132, RBX2660, SER-109, Ridinilazole, MK-6072, MK-3415A, SOC, Cadazolid, and others.
- The Clostridium Difficile Infections Companies and academics are working to assess challenges and seek opportunities that could influence Clostridium Difficile Infections (Clostridium Difficile Associated Disease) R&D. The therapies under development are focused on novel approaches to treat/improve Clostridium Difficile Infections (Clostridium Difficile Associated Disease).
Recent Developmental Activities in the Clostridium Difficile Infections Pipeline
- Rebiotix Inc., a Ferring Company, has conducted several trials of the lead microbiota-based product in the MRT™ drug platform, RBX2660, for reducing the rate of recurrence of Clostridioides difficile infection. RBX2660 is currently under study in a Phase 3 clinical trial in conjunction with the US Food and Drug Administration’s Investigational New Drug application.
- SER-109 is a first-in-class investigational microbiome therapeutic administered orally following antibiotics to reduce recurrence of C. difficile infection (CDI) in patients with recurrent CDI. SER-109 is comprised of purified Firmicutes spores, based on their modulatory role in the life cycle of C. difficile and disease pathogenesis. The FDA has granted SER-109 Breakthrough Therapy Designation and Orphan Drug Designation. In a Phase 3 clinical trial, SER-109 achieved high rates of sustained clinical responses with a favorable safety profile comparable to placebo in patients with recurrent CDI.
- Ibezapolstat (formerly named ACX-362E) is our lead antibiotic candidate. Ibezapolstat is a first-in-class of a new class of Pol IIIC inhibitors which is in clinical development to treat C. difficile infections or CDI. Current treatments for CDI infections utilize other mechanisms of action while ibezapolstat is the first antibiotic candidate intended to work by blocking the Pol IIIC enzyme in C. difficile. This enzyme is necessary for replication of the DNA of the DNA of the bacterial cell.
- ADS024 is an oral single strain live biotherapeutic product (SS-LBP). A naturally occurring live biotherapeutic product, ADS024 possesses a dual mechanism of action. It is bactericidal toward Clostridioides difficile and degrades Toxins A and B produced by C. difficile while maintaining other components of the microbiome. ADS024 is a single strain multimodal LBP and is manufactured from a pure, clonal bacterial cell bank, yielding a standardized lyophilized drug product eliminating the need to directly source from donor fecal material.
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Clostridium Difficile Infections Overview
Clostridium difficile infection (CDI) is acute diarrhea and colitis that is most often preceded by antimicrobial use and is caused by an anaerobic spore-forming, toxin-producing bacterium. C. difficile is found in water, soil, meats, and vegetables and is particularly common in health care environments, where the spores are difficult to eradicate. Patients are exposed to and ingest C. difficile spores in the health care setting from contact with the environment or health care workers who do not practice good hand hygiene. Clostridium difficile infection is the most common cause of hospital acquired diarrhea and carries significant morbidity and mortality. Current treatment options are limited by high rates of recurrence, and fecal transplantation has proven to be an effective and safe option, with very low rates of recurrence. Initial treatment of CDI involves discontinuation of any nonvital antibiotic therapy and administration of fluid and electrolyte replacement. For mild cases, this treatment may be curative. Persistent symptoms or moderate to severe disease warrant antimicrobial therapy directed against C.difficile. Oral metronidazole remains the first-line therapy for mild to moderate CDI in children. For more severe infection, oral vancomycin is approved by the U.S. Food and Drug Administration (FDA) for CDI. Diagnosis of CDI is based on the presence of clinical symptoms (usually defined as more than three watery, loose or unformed stools within ≤24 hours) coupled with a diagnostic test (usually of a stool specimen) that either detects the presence of the C. difficile organism or its toxin genes or detects C. difficile toxin using an enzyme immunoassay or cell cytotoxin assay. The first steps in effective treatment are to stop any therapy with the offending antibiotic and provide fluid and electrolyte support, if needed. Prevention in the health care environment is focused on preventing patient exposure to spores of C. difficile by utilizing isolation, cohorting, gloves and gowns, and hand washing (alcohol rubs are ineffective against spores). Bleach is used in the environment to eradicate spores. It is exceedingly difficult to prevent spore exposure, so antimicrobial stewardship programs to reduce unnecessary antimicrobial use are extremely effective in limiting the number of susceptible patients.
Clostridium Difficile Infections Pipeline Report
In the Clostridium difficile infection pipeline report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Clostridium Difficile Infections(Clostridium Difficile Associated Disease) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Clostridium Difficile Infections Emerging Drugs Profile
- RBX 2660: Rebiotix
- SER 109: Seres Therapeutics
- Ibezapolstat: Acurx Pharmaceuticals
- ADS 024: Adiso Therapeutics
Clostridium Difficile Infections Pipeline Therapeutic Analysis
There are approx. 25+ key companies which are developing the therapies for Clostridium Difficile Infections (Clostridium Difficile Associated Disease). The companies which have their Clostridium Difficile Infections (Clostridium Difficile Associated Disease) drug candidates in the most advanced stage, i.e. Pre-Registration include, Rebiotix.
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Clostridium Difficile Infections Therapeutics Assessment
The Clostridium Difficile Infections pipeline report proffers an integral view of the Clostridium Difficile Infections emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Clostridium Difficile Infections Pipeline Insight Report
- Coverage- Global
- Clostridium Difficile Infections Companies- Rebiotix, Seres Therapeutics, Acurx Pharmaceuticals, Adiso Therapeutics, Summit Therapeutics, Finch Therapeutics Group, Mikrobiomik Healthcare Company S.L., Crestone, MGB Biopharma, Vedanta Biosciences, Inc., Deinove, Biovertis AG, Lumen Bioscience, and others.
- Clostridium Difficile Infections Pipeline Therapies- Fidaxomicin, DAV132, RBX2660, SER-109, Ridinilazole, MK-6072, MK-3415A, SOC, Cadazolid, and others.
- Clostridium Difficile Infections Emerging Therapies, Clinical Trials, Breakthroughs
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Table of Content
- Introduction
- Clostridium Difficile Infections Executive Summary
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease): Overview
- Clostridium Difficile Infections Pipeline Therapeutics
- Clostridium Difficile Infections Therapeutic Assessment
- Clostridium Difficile Infections(Clostridium Difficile Associated Disease)– DelveInsight’s Analytical Perspective
- Late Stage Products (Pre-Registration)
- RBX 2660: Rebiotix
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Ibezapolstat: Acurx Pharmaceuticals
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- ADS 024: Adiso Therapeutics
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) Key Companies
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) Key Products
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) – Unmet Needs
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) – Market Drivers and Barriers
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) – Future Perspectives and Conclusion
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) Analyst Views
- Clostridium Difficile Infections (Clostridium Difficile Associated Disease) Key Companies
- Appendix
Key Questions
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Clostridium Difficile Infections (Clostridium Difficile Associated Disease) drugs?
- How many Clostridium Difficile Infections (Clostridium Difficile Associated Disease) drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Clostridium Difficile Infections (Clostridium Difficile Associated Disease)?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Clostridium Difficile Infections (Clostridium Difficile Associated Disease) therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Clostridium Difficile Infections (Clostridium Difficile Associated Disease) and their status?
- What are the key designations that have been granted to the emerging drugs?
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