Medically reviewed by Onikepe Adegbola, MD, PhD
A recent paper has highlighted the rapid scientific advancements happening in microbiome therapies for recurrent Clostridiodes difficile. This paper emphasizes that several alternatives to fecal microbial transplantation are underway, leading to the development of oral microbiome-based pharmaceutical products (Table 1). This advancement will certainly change the landscape of microbiome therapies, particularly in recurrent Clostridiodes difficile. This paper is titled “Microbiome therapy for recurrent Clostridioides difficile.” This 2022 paper has been published in The Lancet Microbe.
| Table 1. Emerging Standardized Microbiome Therapies for Recurrent Clostridiodes difficile | ||||
| Innovating Company | Molecule | Therapy Type | Development Stage | Efficacy Results (Prevention of Clostridiodes difficile recurrence) |
| Seres Therapeutics | SER-109 | Donor stool-based oral capsules | Phase 3 trial results announced. | Demonstrated higher prevention of recurrence vs placebo in phase 3 trial (88% vs 60%, respectively) |
| Rebiotix | RBX2660 | Donor stool-based enema suspension | Phase 3 trial results announced | Demonstrated higher prevention of recurrence vs placebo in phase 3 trial (70.4% vs 58.1%, respectively) |
| Finch Therapeutics | CP101 | Donor stool-based oral capsules | Undergoing phase 3 trial | Demonstrated higher prevention of recurrence vs placebo in phase 2 trial (74.5% vs 61.5%, respectively) |
| Destiny Pharma | NTCD-M3 | Cultured bacteria (non-stool-based) containing oral capsules | Completed phase 2 trials; phase 3 trial planned | Demonstrated higher prevention of recurrence vs placebo in phase 2 trial (95% vs 70%, respectively) |
| Vedanta Biosciences | VE303 | Cultured bacteria (non-stool-based) containing oral capsules | Completed phase 2 trials; phase 3 trial planned | Demonstrated higher prevention of recurrence vs placebo in phase 2 trial (86.2% vs 54.5%, respectively) |
As shown in Table 1, some of these therapies have completed phase 3 trials, while others are undergoing or yet to undergo phase 3 trials. The phase 3/phase 2 trial results for almost all of them appear very promising in terms of preventing the recurrence of Clostridiodes difficile. Most of these products are oral capsules, and only one is suspension for enemas.
What Does This Mean For Patients with Clostridiodes difficile?
Patients with Clostridiodes difficile frequently report recurrences. These patients may need a prolongation of antibiotic therapy and may need to be hospitalized. Such patients are currently being offered fecal microbial transplantation as a microbiome-based therapy.
But fecal microbial transplantation comes with many risks, such as the potential for the transmission of coronavirus or multidrug-resistant bacteria. Moreover, fecal microbial transplantation is a non-standard treatment as there can be differences in the donor stool.
In contrast, oral microbiome-based therapies are standardized, more convenient, and do not have risks of transmission of disease-causing viruses or bacteria. Thus, they can be considered a better therapy than fecal microbial transplantation.
What are the Key Takeaways From This Paper?
Though none of the newer microbiome-based products for preventing the recurrence of Clostridiodes difficile have yet been licensed, most of them are in advanced stages of development. It can be hoped that at least one of them may be licensed shortly by the regulators. Therefore, a new therapy for preventing the recurrence of Clostridiodes difficile may see the light of the day soon.
Reference:
Gilbert J. A. (2022). Microbiome therapy for recurrent Clostridioides difficile. The Lancet. Microbe, 3(5), e334. https://doi.org/10.1016/S2666-5247(22)00096-9
