On 5 April, Ferring Pharmaceuticals announced its acquisition of Rebiotix, a clinical-stage biotech focused on the development of microbiome-based therapeutics. By obtaining Rebiotix’s proprietary Microbiota Restoration Therapy (MRT) drug development platform, which features its Phase III Clostridium difficile asset RBX2660, Ferring continues to bet big on the short- and long-term potential of harnessing the microbiome to treat a variety of diseases.
The Rebiotix deal is the latest in a list of microbiome-focused investments by Swiss-based Ferring, which has recently formed partnerships with companies such as MetaboGen and MyBiotics. While details of the agreement were not announced, executives from both companies appear committed to the continued autonomy of Rebiotix, a smart strategy by Ferring given the highly specialised nature of the microbiome drug development space.
Promising pipeline candidates
The MRT platform has thus far yielded promising pipeline candidates for C. difficile, pediatric ulcerative colitis (UC), multidrug-resistant urinary tract infections (UTIs), and hepatic encephalopathy, with its lead asset, RBX2660, currently in Phase III of clinical development for the prevention of recurrent C. difficile infections.
An investigational human microbiota suspension formulated for enema delivery, RBX2660 adheres to specific standardized donor screening and manufacturing processes – a strategy aimed at exploiting a key drawback to fecal microbiota transplant (FMT), a procedure that has shown promise in preventing C. difficile recurrence but has not been fully embraced by regulatory agencies. Having been granted the FDA’s coveted Fast Track and Breakthrough Therapy designations, RBX2660 is currently being evaluated in a randomised, placebo-controlled Phase III study (PUNCHCD3) that aims to evaluate its safety and efficacy in over 250 participants. An oral version (RBX7455), which offers more long-term promise due to the more favourable route of administration, is being investigated in a Phase I study.
According to key opinion leaders (KOLs) interviewed by GlobalData, the treatment and prevention of recurrent C. difficile infections represents a glaring unmet medical need, as current treatment options, such as oral vancomycin, are effective at treating primary infections but leave over 20% of patients vulnerable to recurrences. With GlobalData projecting the market for C. difficile therapeutics to reach $1.7bn across the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, and Japan) by 2026, the acquisition of Rebiotix positions Ferring as a future player in a lucrative marketplace.
Beyond C. difficile, Ferring hopes that its investments in several complementary microbiome technology platforms – headlined by Rebiotix’s MRT, MyBiotics’ MyCrobe and SuperDonor, and MetaboGen’s MeduzaGen – will one day result in products to treat a variety of gastrointestinal, immunological, and metabolic disorders. In the short term, however, GlobalData views RBX2660 as an important asset that will help to shape future microbiome trial design and product positioning regardless of its performance in late-stage studies.
GlobalData (2017). OpportunityAnalyzer: Clostridium difficile Infections – Opportunity Analysis and Forecasts to 2026, July 2017, GDHC070POA.
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