When the FDA approved Rebyota, a new class of Clostridioides Difficile (C.diff) treatment, Ferring Pharmaceuticals ushered in the first significant breakthrough doctors treating the disease have seen in years. Rebyota falls in the class of therapy known as Fecal Microbiota Transplant, or FMT, a therapy over 60% of treating gastroenterologists believe will dramatically change the paradigm of C.diff treatment in the next five years, according to research from Spherix Global Insights Market Dynamix™ Clostridioides Difficile (US) service.
At least two additional FMT treatments are in development for C.diff, including Aimmune/Seres’ SER-109 and Vedanta Biosciences’ VE303. Finch Pharmaceuticals recently discontinued their FMT development program for CP101.
With a first to market advantage, Ferring’s Rebyota has seen early positive adoption from gastroenterologists and infectious disease specialist in the first month post-launch. As part of their Launch Dynamix™: C.diff service, Spherix reports, while new monthly initiations are modest, a majority of physicians trialing Rebyota report high satisfaction.
A few headwinds Ferring may be facing with Rebyota include its mode of administration, and storage and handling requirements. Rebyota is administered as a single dose enema in a doctor’s office. Doctors who spoke with Spherix were cautious in how patients might receive this. Specifically, respondents commented, “I don’t want enemas as a way of introduction to treat” and “patients are less likely to feel comfortable with enemas,” yet others offered that after recurring disease, the patient population would be more open to enema treatments. Additionally, Rebyota’s package insert states: “Store the REBYOTA carton in an ultracold freezer (-60˚C to -90˚C, -76˚F to -130˚F). It can then be thawed prior in a standard refrigerator and stored up to 5 days prior to use.” While unique handling requirement are not uncommon for gastroenterology/infectious disease practices, this may limit the number of specialists that can accommodate the handling limitations.
SER-109, set for an FDA PDUFA decision in April 2023, presents a different option for administration. Published data from the ECOSPOR III trial describes SER-109 as 4 matching oral capsules taken once daily over 3 consecutive days. Links to the trial protocol describe the administration process as including “confirmation of standard of care antibiotic dosing” and “consumption of 10 oz (300 mL) of magnesium citrate or 250 mL of GoLytely the day before SER-109 dosing.” In other words, SER-109 is an oral medication taken after antibiotic standard of care and a single bowel prep.
When launched, each therapy will have benefits to promote and implications to manage. Rebyota describes the drug as delivered “directly where needed,” in a single dose, with no additional preparation. However, it is an enema and comes with extraordinary handling and storage requirements. SER-109 is an oral therapy that can be stored at room temperature, although it may require a bowel prep before taking. Both showed significant reduction in recurrence of C.diff.
Physicians surveyed by Spherix showed a fairly large preference for SER-109, with commentary emphasizing, “I would strongly urge my patients to take this medication” and “SER-109 appears to be a safe, single dose administration option for C.diff and is efficacious”
For patients, both therapies offer a welcome improvement over the prevailing standard of care and promise to reduce the suffering experienced by those unfortunate enough to contract C.diff. Spherix will continue to monitor the launch of Rebyota and, pending approval, the uptake and impact of SER-109 for C.diff via the Launch Dynamix™ service for the first eighteen months of each brands’ commercial availability.
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