SAINT-PREX, Switzerland & PARSIPPANY, N.J. - Friday, 21. October 2022 AETOSWire
Subgroup analysis of Phase 3 trial (PUNCH™ CD3) looked at health-related quality of life data in patients treated with RBX2660 versus placebo
Separate subgroup analysis reviewed efficacy and safety data for RBX2660 across a range of patients including those over age 65 years with recurrent C. difficile infection and existing comorbidities
(BUSINESS WIRE)--Ferring Pharmaceuticals today announced the presentation of two subgroup analyses at Infectious Disease Week (IDWeek) 2022 that further characterize RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection (CDI) after antibiotic treatment.
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These subgroup analyses reviewed data from the PUNCH™ CD clinical program and included a subgroup analysis which assessed the impact of treatment with RBX2660 versus placebo on the health-related quality of life (HRQL) in participants with recurrent CDI (rCDI), as well as a separate subgroup analysis which looked at outcomes in older patients with rCDI with cardiac, renal, and gastrointestinal (GI) comorbidities.
The first subgroup analysis (Significant Improvement in Health-Related Quality of Life (HRQL) With RBX2660: Results from A Phase 3 Randomized, Placebo-Controlled Trial in Recurrent Clostridioides Difficile Infection (PUNCH CD3); poster number 522) assessed the impact of treatment with RBX2660 versus placebo on HRQL. The results were based on the Clostridioides difficile Health-related Quality of Life Questionnaire (Cdiff32), a disease-specific instrument that measures physical, mental, and social domains. Changes in Cdiff32 from baseline to week 8 were compared between RBX2660 and placebo (PBO) using unadjusted and adjusted analyses controlling for baseline scores, demographics, and disease characteristics. Of the 206 participants (140-RBX2660, 66-placebo) included in the analysis, Cdiff32 scores improved significantly from baseline to weeks 1, 4, and 8 in both treatment arms with greater improvements for the RBX2660 arm through week 8. At week 8, statistical differences were found for mental domain and total score, all favoring RBX2660.
“The treatment effect observed in the subgroup analysis suggests that RBX2660 may help improve the quality of life for patients following CDI recurrence,” said Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., Yale University School of Medicine and an author of both studies.
The second subgroup analysis (Treatment of Recurrent Clostridioides difficile Infection with RBX2660 in Patients ≥ 65 Years Old with Underlying Comorbidities; poster number 236) assessed 8-week outcomes in the PUNCH CD3 Phase 3 trial of 119 participants (87-RBX2660, 32-placebo) over 65 years old with underlying cardiac disorders (42%), chronic kidney disease (CKD) (19%), and GI disorders (61%). Treatment success in the trial was defined as remaining free of CDI recurrence 8 weeks after treatment. Treatment success rates were consistent across all RBX2660 groups, 69% for participants 65 years of age and older and 69%, 68%, and 67% for those with a cardiac disorder, CKD, or GI disorder, respectively. In the total safety population, the overall incidence of treatment-emergent adverse events (TEAEs) was 52% with RBX2660 treatment versus 44% with placebo treatment. Among participants with a cardiac disorder, CKD, or GI disorder, the incidence of TEAEs was 61%, 68%, and 51%, respectively. Most TEAEs were mild or moderate in severity and related to a pre-existing condition.
About C. difficile infection
C. difficile infection (CDI) is a serious and potentially deadly disease that impacts people across the globe. The C. difficile bacterium causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis (an inflammation of the colon).1 Declared a public health threat by the U.S. Centers for Disease Control and Prevention (CDC) requiring urgent and immediate action, CDI causes an estimated half a million illnesses and tens of thousands of deaths in the U.S. alone each year.1,2,3
C. difficile infection often is the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.4,5 It has been estimated that up to 35% of CDI cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections.6,7,8,9 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.8,9
RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection after antibiotic treatment. RBX2660 has been granted Orphan and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). RBX2660 was developed by Rebiotix, a Ferring company.
About the PUNCH™ CD3 Clinical Trial (Clinicaltrials.gov identifier: NCT03244644)
PUNCH CD3 is a Phase 3, prospective, multi-center, randomized, double-blinded, placebo-controlled clinical trial evaluating the efficacy and safety of RBX2660 vs. placebo in preventing rCDI. The study included adults ages 18 or older who had at least one recurrence after a primary episode of CDI. Participants were followed up to 8 weeks for the efficacy analysis, and up to six months for the safety analysis. The TEAEs were mild-to-moderate GI symptoms in both the RBX2660 and placebo treated arms.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately owned Ferring now employs around 6,000 people worldwide, has its own operating subsidiaries in more than 50 countries, and markets its products in 110 countries.
Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.
Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. Ferring is working to develop novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.
IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). IDWeek is a recognized forum for peer-reviewed presentations of new research on scientific advances and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. For more information, visit www.idweek.org.
Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available from: https://www.cdc.gov/cdiff/what-is.html
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Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. 2021;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11.
Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(suppl 6):21–27.
Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
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