ROSEVILLE, Minn., April 24, 2018 /PRNewswire/ -- Rebiotix Inc. announced today the presentation of two posters during the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018) being held in Madrid, Spain. Collectively, the posters add to the growing library of data recently published and presented by Rebiotix highlighting the company's microbiome drug products, clinical programs, and pioneering research involving microbiome composition and health.
"The analysis of our RBX2660 Phase 2B and open-label Phase 2 clinical trials and additional findings from the Microbiome Health Index™ presented at ECCMID 2018 serve to demonstrate the potential of our microbiota-based drug platform to restore a dysbiotic microbiome and potentially prevent recurrent Clostridium difficile (C. diff) infection," said Lee Jones, Rebiotix's president and CEO. "Moreover, the data presented at ECCMID 2018 exemplify an ongoing mission at Rebiotix to conduct scientific research to explore the potential of our microbiome drug products and to advance the understanding of the human microbiome itself."
The first poster (P0368) titled, "The Microbiota-based Drug RBX2660 is Efficacious and Safe in Patients with Recurrent Clostridium Difficile Infections: Results from 2 Controlled Clinical Trials," provided a comparative analysis from the Phase 2B (PUNCH CD2) and open-label Phase 2 (PUNCH SOS) clinical trials of RBX2660 for the prevention of recurrent C. diff infection (rCDI). According to the researchers, the data collectively demonstrate the safety and the effectiveness of RBX2660 in preventing rCDI when compared to placebo-treated and historical control groups. These two controlled studies provided the foundational data for advancing RBX2660 into the current, ongoing Phase 3 clinical trial for the prevention of rCDI. In total, 369 rCDI patients were evaluated across both Phase 2 trials. In the Phase 2B trial, the efficacy among patients who received >1 blinded RBX2660 treatment was 66.7% (n=83) compared to 45.5% for placebo-treated patients (n=42; p<0.05). In the multi-center Open-Label Phase 2 trial, efficacy among patients who received >1 RBX2660 treatment was 79.4% (n=136), compared to 51.8% in the Control group (n=110) and was highly significant (p<0.0001).
In the second poster (P0369) titled, "Developing Microbiome Rehabilitation Biomarkers for Clostridium difficile Infections: Evaluation of a Prototype Microbiome Health Index™ (MHI™)," the researchers explored the potential of the MHI to enable a non-biased comparison of the efficacy of microbiome-based therapeutics by providing a unidimensional expression of changes in four taxonomic classes known to have relevance to microbiome health and colonization resistance – Bacteriodia, Clostridia, Gammaproteobacteria and Bacilli. This analysis, through statistical measures and in clinical trials, distinguishes patients with rCDI dysbiosis from controls and illustrates MHI increases can be measured post-treatment of RBX2660 to demonstrate restoration toward a healthier microbiome composition.
About Rebiotix Inc. Rebiotix Inc, which is part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection. Rebiotix's clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy™ (MRT™) platform. The MRT platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient's intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.
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 women's health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company's research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
Learn more at www.ferring.com
Rebiotix Media Contact: Jason Rando Tiberend Strategic Advisors 212-375-2665 [email protected]
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"The analysis of our RBX2660 Phase 2B and open-label Phase 2 clinical trials and additional findings from the Microbiome Health Index™ presented at ECCMID 2018 serve to demonstrate the potential of our microbiota-based drug platform to restore a dysbiotic microbiome and potentially prevent recurrent Clostridium difficile (C. diff) infection," said Lee Jones, Rebiotix's president and CEO. "Moreover, the data presented at ECCMID 2018 exemplify an ongoing mission at Rebiotix to conduct scientific research to explore the potential of our microbiome drug products and to advance the understanding of the human microbiome itself."
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The first poster (P0368) titled, "The Microbiota-based Drug RBX2660 is Efficacious and Safe in Patients with Recurrent Clostridium Difficile Infections: Results from 2 Controlled Clinical Trials," provided a comparative analysis from the Phase 2B (PUNCH CD2) and open-label Phase 2 (PUNCH SOS) clinical trials of RBX2660 for the prevention of recurrent C. diff infection (rCDI). According to the researchers, the data collectively demonstrate the safety and the effectiveness of RBX2660 in preventing rCDI when compared to placebo-treated and historical control groups. These two controlled studies provided the foundational data for advancing RBX2660 into the current, ongoing Phase 3 clinical trial for the prevention of rCDI. In total, 369 rCDI patients were evaluated across both Phase 2 trials. In the Phase 2B trial, the efficacy among patients who received >1 blinded RBX2660 treatment was 66.7% (n=83) compared to 45.5% for placebo-treated patients (n=42; p<0.05). In the multi-center Open-Label Phase 2 trial, efficacy among patients who received >1 RBX2660 treatment was 79.4% (n=136), compared to 51.8% in the Control group (n=110) and was highly significant (p<0.0001).
In the second poster (P0369) titled, "Developing Microbiome Rehabilitation Biomarkers for Clostridium difficile Infections: Evaluation of a Prototype Microbiome Health Index™ (MHI™)," the researchers explored the potential of the MHI to enable a non-biased comparison of the efficacy of microbiome-based therapeutics by providing a unidimensional expression of changes in four taxonomic classes known to have relevance to microbiome health and colonization resistance – Bacteriodia, Clostridia, Gammaproteobacteria and Bacilli. This analysis, through statistical measures and in clinical trials, distinguishes patients with rCDI dysbiosis from controls and illustrates MHI increases can be measured post-treatment of RBX2660 to demonstrate restoration toward a healthier microbiome composition.
About Rebiotix Inc. Rebiotix Inc, which is part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection. Rebiotix's clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy™ (MRT™) platform. The MRT platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient's intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.
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 women's health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company's research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
Learn more at www.ferring.com
Rebiotix Media Contact: Jason Rando Tiberend Strategic Advisors 212-375-2665 [email protected]
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