Ferring Presents New Analyses of Efficacy, Safety and Microbiome Composition Data at DDW 2022 for RBX2660 its Investigational Microbiota-Based Live Bi
Data adds to the growing body of evidence of the RBX2660 clinical development program the largest, most robust program conducted in the field of microbiome-based therapeutics for recurrent C. difficile infection (rCDI).
뉴스일자: 2022-05-25
SAINT-PREX, SWITZERLAND & PARSIPPANY, NJ, USA-- May 25, 2022 -- Ferring Pharmaceuticals today announced the presentation of four abstracts at Digestive Disease Week (DDW) 2022 that further characterize RBX2660, a potential first-in-class microbiota-based live biotherapeutic studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.
less of their baseline characteristics.
The first abstract (RBX2660 Versus Placebo to Reduce the Recurrence of Clostridioides Difficile Infection: Subgroup Analysis; Session number 892), an oral presentation, was a subgroup analysis of integrated data from randomized participants who received one dose of blinded treatment of RBX2660 (n=221) or placebo (n=131) in the PUNCH CD2 and PUNCH CD3 trials. In the analysis, participants who received RBX2660 demonstrated greater treatment success compared to placebo (68.3% vs. 55.0%, respectively; P=0.012). Treatment success was defined as remaining recurrence-free for 8 weeks after treatment. There were no differences in treatment success observed based on age, sex, race, ethnicity, site geography, number of previous episodes of CDI recurrence, or duration of antibiotic use prior to study entry (P>0.05).
“The consistent treatment effect with RBX2660 observed in the study, regardless of risk factors associated with recurrence such as older age, female gender, antibiotic use and underlying conditions, demonstrates the potential for RBX2660 to reduce CDI recurrence in a broad patient population,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine. “These findings - in combination with the overall RBX2660 data presented at DDW - further support the potential efficacy and safety of RBX2660 in patients with rCDI.”
The second subgroup analysis (Treatment Success of RBX2660 in Reducing Recurrent Clostridioides difficile Infection in Patients with Underlying Comorbidities; Poster number Su1600) included participants in the modified intent-to-treat study population (n=262) of the PUNCH CD3 trial who were stratified by underlying comorbidities as mild (n=107), moderate (n=71), and severe (n=84) based on baseline Charlson Comorbidity Index (CCI) scores. The CCI is comprised of a number of comorbid conditions - such as cardiovascular and cerebrovascular diseases, any type of cancer, diabetes, and liver or kidney diseases, among others - and provides an estimate for risk of long-term mortality, with severe CCI scores equating to a higher risk of death. Participants with moderate and severe CCI scores had more CDI episodes compared with those who had a mild score.
Across all CCI subgroups, participants who received RBX2660 showed greater and consistent treatment success compared to placebo. The percentage of patients achieving treatment success with RBX2660 vs. placebo, respectively, were as follows: 76.5% vs. 71.8% (mild CCI), 68.0% vs. 57.1% (moderate CCI), and 67.8% vs. 52.0% (severe CCI). The absolute difference in treatment success rates between RBX2660 and placebo increased with increasing comorbidity burden (mild, 5%; moderate, 11%; severe, 16%).
Most treatment-emergent side effects were mild or moderate regardless of underlying comorbidities. Serious adverse events were infrequent and reported in a similar percentage of participants regardless of treatment or underlying comorbidities. One participant with a severe CCI score who received RBX2660 experienced an adverse event leading to death but no deaths or serious AEs were considered related to RBX2660 or its administration.
