Rebyota is under clinical development by Rebiotix and currently in Phase I for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase I drugs for Crohn’s Disease (Regional Enteritis) have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Rebyota’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Rebyota overview

Fecal microbiota, live-jslm (Rebyota) is an opaque first fecal microbiota product. It is formulated as suspension for the rectal route of administration. Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

RBX-2660 is under development for the treatment of Crohn's disease, recurrent Clostridium difficile infection-associated diarrhea. The drug candidate is a fecal microbiota administered through rectal route which is formulated as an enema. The drug candidate is microbiota suspension which is an intestinal preparation containing live microbes which are used as Microbial Restoration Therapy (MRT) restores the normal microbiota through the transplantation of live microorganisms. The drug candidate is partnered after fecal transplant (FT) therapy.

It was also under development for urinary tract infection, vancomycin-resistant Enterococcus faecium Infections, hepatic encephalopathy and pediatric ulcerative colitis and inflammatory bowel disease unclassified (IBD-U).

Rebiotix overview

Rebiotix a subsidiary of Ferring Holding SA, is a clinical stage biotechnology company that develops treatments for debilitating diseases. The company’s pipeline products include RBX2660, RBX7455. Its RBX2660 is available in the form of enema formulation used for the treatment recurrent clostridium difficile infection. Rebiotix’s RBX7455 is an oral formulation in a lyophilized form. The company partners with physicians to evaluate the use of Microbiota Restoration Therapy (MRT) for ulcerative colitis, crohn’s disease, chronic idiopathic constipation, myoclonus dystonia, autism, urea cycle disorders, chronic fatigue syndrome hepatic encephalopathy and multi drug-resistant organisms. Rebiotix is headquartered in Roseville, Minnesota, the US.

For a complete picture of Rebyota’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.