Ferring Presents Award-Winning, Real-World Outcomes Analysis for Investigational Microbiota-Based Live Biotherapeutic, RBX2660, at ACG 2021

New retrospective analysis found RBX2660 demonstrated efficacy and safety outcomes among a real-world population of C. difficile (CDI) patients, including those with comorbidities previously excluded from clinical trials
Analysis adds to the consistent body of efficacy and safety evidence for RBX2660 across prospective and retrospective analyses and varying patient populations

2021-10-26 16:40 출처: Ferring Pharmaceuticals

PARSIPPANY, N.J.--(뉴스와이어) 2021년 10월 26일 -- Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced the results of two key retrospective analyses at the American College of Gastroenterology 2021 annual congress. One analysis evaluated the safety and efficacy of investigational RBX2660 among a broad cohort of CDI patients with comorbidities commonly found in patients with CDI, and was recognized with a Presidential Poster Award for high-quality, novel, unique and interesting research.

While the eligibility criteria in prospective clinical trials often are narrowly defined to include patients diagnosed with only CDI, this analysis allowed researchers to evaluate the impact of RBX2660 in a patient population that is more reflective of a real-world setting. In the analysis, 94 participants with comorbid conditions commonly found in people with recurrent CDI (rCDI) were treated with RBX2660 under a U.S. Food and Drug Administration (FDA) Enforcement Discretion policy. The analysis showed a treatment success rate of 82.8%, with no observable difference between participants who received one dose (83.3%) vs. two doses (82.5%). Treatment success was defined as absence of CDI recurrence at 8 weeks post administration of RBX2660. Among participants who responded to treatment after the first dose, 88.7% demonstrated a sustained clinical response to six months. Safety outcomes in this real-world analysis were comparable to prospective studies with most treatment-emergent adverse events being mild to moderate in severity.[1]

“The results of this retrospective study provide critical additional information about RBX2660, as it supports the concept that data observed in well-controlled, prospective clinical trials may be replicable in a real-world setting,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine. “This research shows that even with wide eligibility criteria, RBX2660 performed similarly to the more narrow and limited inclusion for the Phase 2 and 3 trials. This retrospective study included patients across different comorbidities who are more representative of the population living with C. difficile and remain vulnerable to the debilitating cycle of recurrence.”

The comorbid conditions represented in this population included: gastroesophageal reflux disease (47.9%); irritable bowel syndrome (17%); gastritis (11.7%); constipation (8.5%); microscopic colitis (7.4%); diverticulitis (6.4%); Crohn’s disease (5.3%); and ulcerative colitis (4.3%).[1]

In a second abstract, researchers conducted a real-world comparison of outcome rates and healthcare resource utilization among patients ages 65 or older who had at least one CDI episode with or without co-occurring IBD. The analysis, based on Medicare data analyzed between 2009 and 2017, included a total of 497,489 patients with CDI, including 36,059 diagnosed with IBD. Overall, the rate of death among patients with CDI was higher among those without co-occurring IBD, including Crohn’s disease (CD) (42.9% vs. 34.7% with CD; p<0.0001) and ulcerative colitis (UC) (42.9% vs. 40.0% with UC; p<0.0001). Among patients with IBD, mortality was higher among those with primary CDI (CD 37.6%; UC 44.6%) vs. recurrent CDI (CD 28.7%; UC 31.1%; p<0.001).[2]

While all the groups studied had high rates of hospitalization - between 86% and 99% (p<0.0001) - those with CDI and IBD used more healthcare resources, including longer hospital stays and higher 30-day readmission rates. Among patients who died, those with CDI and UC had significantly higher monthly costs versus those with CD. The researchers noted that, given their elevated risk, CDI patients with IBD are likely to be identified more rapidly and require more resources to stabilize both conditions, which may explain the lower death rates but higher healthcare usage.[2]

About the gut microbiome and 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).[3] 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.[3,4,5]

C. difficile infection often is the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.[6,7] Up to 35% of CDI cases recur after initial diagnosis[8,9] and people who have had a recurrence are at significantly higher risk of further infections.[10,12,12,13] After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.[14]

Recurrent C. difficile infection (rCDI) is associated with disruptions to the gut microbiome, or “dysbiosis”. The gut microbiome is a highly-diverse microbial community that plays an essential role in human health. There is a growing body of evidence that shows when there is a disruption of the composition and/or diversity of the gut microbiome, there may be an associated risk for serious illnesses, including CDI. The current standard of care treatment for rCDI is antibiotics, which does not address the underlying dysbiosis or restore the gut microbiome.[14] The use of antibiotics has been shown to disrupt the ecology of the gut microbiome and are a predominant risk factor for rCDI.[8,9,15]

Restoring the gut microbiome is increasingly accepted as a promising treatment option for recurrent C. difficile infection.[16]

About RBX2660

RBX2660 is a potential first-in-class microbiota-based live biotherapeutic being studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent C. difficile infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). The pivotal Phase 3 program builds on nearly a decade of research with robust clinical and microbiome data collected over six controlled clinical trials with more than 1,000 participants.

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 approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. The Ferring Research Institute Inc. (FRI), based in San Diego, USA, is part of the Global Drug Discovery & External Innovation unit, which is the research and ideas engine of Ferring Pharmaceuticals. FRI is an integral part of Ferring’s R&D organization, focusing on early drug discovery and development. 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. With the 2018 acquisition of Rebiotix and several other alliances, Ferring is a world leader in microbiome research, developing 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.

About Rebiotix

Rebiotix Inc, a Ferring Company, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRTTM drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com, or connect with us on Twitter, Facebook, LinkedIn and YouTube.

About ACG

The American College of Gastroenterology (ACG) is a recognized leader in educating gastrointestinal (GI) professionals and the general public about digestive disorders. Our mission is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation, and advocacy in the areas of scientific investigation, education, prevention, and treatment. More information can be found at www.gi.org.

References:

[1] Feuerstadt, P, Harvey, A, Bancke, L. RBX2660, an Investigational Live Microbiota-Based Biotherapeutic, Improves Outcomes of Clostridioides difficile Infection in a Real-World Population: A Retrospective Study of Use Under Enforcement Discretion. Presented at ACG 2021 Annual Scientific Meeting & Postgraduate Course. October 22-27, 2021. Poster #P2217.
[2] Feuerstadt, P, Dahdal, D., Wong, A., et al. A Real-World Comparison of Mortality, Healthcare Resource Utilization, and Cost Among Medicare Beneficiaries with Clostridioides difficile Infection (CDI) With and Without Inflammatory Bowel Disease (IBD). Presented at ACG 2021 Annual Scientific Meeting & Postgraduate Course. October 22-27, 2021. Poster #2611.
[3] Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
[4] Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html
[5] Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
[6] Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
[7] Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
[8] Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
[9] Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154-61.
[10] Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
[11] Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims. J Manag Care Spec Pharm. Published online March 11, 2021.
[12] Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21-27.
[13] Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
[14] Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.
[15] Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med. 2016;8(1):39.
[16] van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013;368(5):407-415.

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