European Pharmaceutical Review

OCTOBER 11, 2023

As part of newly acquired assets from live biotherapeutics products (LBP) manufacturer Federation Bio, Kanvas Biosciences now has two active microbiome-based clinical programmes. This acquisition allows us to manufacture and clinically investigate complex microbial consortia much faster than previously envisioned.

Manufacturing 80

Manufacturing Medicine Patients Leads 80

Pharmaceutical Technology

APRIL 26, 2023

Vedanta Biosciences intends to use the funds to advance a pivotal Phase III trial of its lead candidate, VE303, to prevent recurrent clostridioides difficile infection (CDI). It comprises eight types of clonal human commensal bacteria strains chosen to offer colonisation resistance to C difficile.

Medicine 52

Medicine Management Leads Pharmaceutical 52

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). The study showed that at eight weeks post-treatment 88% of subjects in the SER-109 group were free from C.

FDA 45

FDA Prescription Food Medical 45

Pharmacy Times

OCTOBER 5, 2022

Drs Feuerstadt, Abraham, and Chopra discuss clinical trial data for RBX2660, a live biotherapeutic product, in treatment of recurrent C difficile infection (rCDI), as well as data with RBX2660 that were presented at DDW 2022.

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European Pharmaceutical Review

JUNE 27, 2023

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. What are the most promising microbiome therapeutics in clinical development?

Food and Drug Administration 100

Food and Drug Administration Manufacturing Medicine Pharma 100

European Pharmaceutical Review

FEBRUARY 14, 2024

Achieving drug substance and drug product reproducibility is a major challenge to be overcome during product development and clinical supply of live biotherapeutic (LBP) therapies. Clinical supplies Careful consideration is necessary during clinical trial dossier compilation and the setting of drug product specifications.

Food and Drug Administration 80

Food and Drug Administration Manufacturing Engineering Pharmacology 80

European Pharmaceutical Review

JANUARY 10, 2024

As late-stage clinical development, manufacturing, quality control processes and regulation for microbiome-based treatments evolve, standardisation becomes a critical and complex challenge. Recognition of the potential of manipulating and harnessing the gut microbiome to treat and prevent disease, has seen a wave of clinical trials emerge.

Medicine 52

Medicine Manufacturing Leads Networking 52

European Pharmaceutical Review

APRIL 10, 2024

Engaging in continuous dialogue with regulatory bodies in Europe and the US helps in designing clinical trials that follow the latest safety standards and international regulations. During the development of clinical trials that use faecal-derived material, the necessity of safety is paramount.

Safety 85

Safety Patients Medical FDA 85

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. First faecal microbiota product approved for C. diff What did the safety analysis show?

Safety 97

Safety Food and Drug Administration Prospecting Food 97

MedCity News

JANUARY 24, 2023

Clinical trial setbacks and financial challenges have led Finch Therapeutics to stop a Phase 3 study for its lead microbiome program, a potential treatment for recurrent C. diff infection. As Finch seeks buyers for its remaining assets, the biotech is laying off most of its staff in a corporate restructuring.

Leads 98

Leads Biopharma Pharma 98

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. The announcement is not just a milestone for people living with recurrent C.

Food and Drug Administration 105

Food and Drug Administration FDA Food Safety 105

European Pharmaceutical Review

JULY 10, 2023

In a world-first clinical trial published Nature Medicine , a multi-centre study found 65 percent of advanced melanoma patients who retained the donors’ microbiome after a faecal microbiota transplants (FMT) had a clinical response to immunotherapy. First faecal microbiota product approved for C. difficile infections.

Medicine 90

Medicine Patients Medical Pharmaceutical 90

pharmaphorum

JANUARY 16, 2023

The fundamentals are compelling: approximately 2% of healthcare expenditure is on IVDs, yet, they are involved with around 66% of clinical decisions and are critical to an improved focus on primary care-centred, patient driven, preventative healthcare. Difficile treatment, Ser-109.

FDA 80

FDA Healthcare Healthcare Medicine 80

European Pharmaceutical Review

JANUARY 16, 2023

presented their pathway for regulatory approval to the FDA Vaccines and Related Biological Products Advisory Committee for a faecal microbiota-based live biotherapeutic to treat recurrent Clostridioides difficile infection, which is a major Healthcare Acquired Infection (HAI). Molecular Therapy – Methods & Clinical Development.

Pharmaceutical 127

Pharmaceutical Food and Drug Administration Manufacturing FDA 127

Pharmaceutical Technology

MAY 31, 2023

Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. Aureus, Acinetobacter and C. difficile in difficult-to-treat infections in the future. Following these results, SNIPR has now set its sights on future studies to evaluate SNIPR001’s ability to target E.Coli in cancer patient.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98