Ferring and Rebiotix Present Positive Interim Phase 3 Results From Open-Label Study of Investigational Microbiota-Based Live Biotherapeutic RBX2660 at Digestive Disease Week® (DDW)

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SAINT-PREX, Switzerland & ROSEVILLE, Minn. — Ferring Prescribed drugs and Rebiotix, a Ferring Firm, introduced at present the primary presentation of interim knowledge from a Section 3 open-label examine exhibiting robust developments in efficacy and security for investigational microbiota-based dwell biotherapeutic RBX2660 in lowering recurrent Clostridioides difficile (C. difficile) an infection over six months, per earlier findings within the complete RBX2660 medical growth program. The examine additionally enrolled sufferers identified with co-morbid circumstances akin to inflammatory bowel illness (IBD) and irritable bowel syndrome (IBS). The sufferers enrolled intently mirror the recurrent C. difficile an infection sufferers who healthcare suppliers deal with each day. The outcomes had been introduced at Digestive Illness Week^® (DDW) 2021, happening nearly this yr from Could 21-23.

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“These knowledge are important as a result of eligibility standards for such research are sometimes inflexible and exclude sufferers with probably confounding co-morbid circumstances. In distinction, eligibility standards for the PUNCH CD3 open-label examine had been much less restrictive, mimicking actual medical apply,” mentioned Colleen Kraft, MD, MSc, Affiliate Professor, Division of Infectious Illnesses, Emory College Faculty of Drugs, Atlanta, Ga., and presenting creator. “This interim evaluation helps the security and efficacy of RBX2660 in lowering CDI recurrence in a affected person inhabitants consultant of ordinary medical apply, together with these with a co-diagnosis of IBD and/or IBS. The noticed efficacy and security are additionally per different trials of RBX2660, with the sustained efficacy at six months suggesting a possible long-term profit.”

On the time of the interim evaluation, 75% of individuals whose therapy outcomes may very well be analysed (n=60) had been freed from C. difficile an infection at 8 weeks. Amongst sufferers with therapy successes who additionally reached six-month follow-up (n=27), 74% remained symptom-free. About half (49%) of sufferers reported treatment-emergent adversarial occasions (TEAEs). The commonest TEAEs had been gastrointestinal, and gentle to average in nature. These preliminary findings construct on, and are supportive of, the information from the Section 3 PUNCH™ CD3 randomized, placebo-controlled trial, which had been introduced at DDW on Could 21.

The RBX2660 program is the most important and most strong medical program ever carried out within the area of microbiome-based therapeutics, together with six trials involving greater than 1,000 sufferers. Along with the interim six-month efficacy and security seen within the PUNCH CD3-OLS, the Section 2b double-blind, randomized, placebo-controlled trial (PUNCH CD2) and the Section 2 open-label examine (PUNCH Open Label) confirmed medical response for as much as two years publish therapy.

“Our medical program is the one one to seize constant proof over six medical trials, repeatedly demonstrating the efficacy and security of RBX2660,” mentioned Ken Blount, Chief Scientific Officer, Rebiotix and Vice President of Microbiome Analysis, Ferring Prescribed drugs. “The interim outcomes of the PUNCH CD3-OLS, which encompasses rCDI sufferers that clinicians see of their day by day apply, affirm the constant security we’ve seen with RBX2660 over the course of this growth program. We imagine RBX2660 might assist tens of 1000’s of people that expertise recurrent C. difficile an infection yearly – these knowledge are a vital demonstration of RBX2660’s potential.”

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Retrospective Examine Exhibits Devastating Well being, Monetary Influence of Sepsis in CDI Sufferers
Along with the PUNCH CD3-OLS outcomes, Ferring introduced a second poster evaluating the speed of loss of life, healthcare useful resource utilization (HRU), and value amongst U.S. Medicare beneficiaries with major CDI (pCDI) and rCDI with and with out sepsis – sepsis is a life-threatening medical emergency brought on by the physique’s excessive response to an an infection and a typical complication in sufferers with C. difficile an infection. Total, 41 p.c of all sufferers had sepsis, which was extra frequent in sufferers with rCDI than these with pCDI (45.1% vs. 39.2%, respectively). Sufferers with sepsis had been extra prone to die than these with out sepsis (57.7% vs. 32.4%, respectively).

Amongst those that died, C. difficile an infection sufferers with sepsis, particularly these with rCDI, had considerably larger charges of intensive care unit (ICU) use, longer hospital stays, and better healthcare prices versus C. difficile an infection with out sepsis. Particularly:

Prices for sufferers with sepsis who survived had been decrease however had the same sample in comparison with these with out sepsis (pCDI: $10,093 vs. $4,930; rCDI: $12,013 vs. $5,707).

“These knowledge present that recurrent C. difficile an infection and ensuing problems akin to sepsis have a devastating and probably lethal affect on sufferers, and locations a big burden on the general healthcare system,” mentioned James Tursi, MD, Chief Scientific Officer, Ferring Prescribed drugs USA. “Pressing motion is required to halt the unrelenting cycle of recurrence seen with this illness. We’re dedicated to additional analysis that helps generate a higher understanding of the magnitude of C. difficile an infection with a view to assist sufferers dwell higher lives.”

About RBX2660
RBX2660 is a possible first-in-class microbiota-based dwell biotherapeutic being studied to ship a broad consortium of various microbes to the intestine to scale back recurrent C. difficile an infection. RBX2660 has been granted Quick Monitor, Orphan, and Breakthrough Remedy designations from the U.S. Meals and Drug Administration (FDA). The pivotal Section 3 program builds on almost a decade of analysis with strong medical and microbiome knowledge collected over six managed medical trials with greater than 1,000 individuals.

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In regards to the microbiome and C. difficile an infection
The microbiome is a highly-diverse microbial group that performs a vital position in human well being. There’s a rising physique of proof that reveals when there’s a disruption of the composition and/or range of the intestine microbiome, there could also be an related threat for critical sicknesses, akin to C. difficile an infection.

C. difficile is a bacterium that causes debilitating signs akin to extreme diarrhea, fever, abdomen tenderness or ache, lack of urge for food, nausea and colitis (an irritation of the colon).¹ Estimated to trigger as much as half 1,000,000 sicknesses and 1000’s of deaths yearly within the US alone yearly, C. difficile an infection is taken into account an pressing menace to public well being by the CDC and may result in extreme problems, together with hospitalization, surgical procedure, sepsis and loss of life.^1,2 C. difficile an infection is commonly the beginning of a vicious cycle of recurrence, inflicting a big burden for sufferers and the healthcare system.^3,4 Theuse of antibiotics has been proven to disrupt the ecology of the intestine microbiome, and are a predominant threat issue for C. difficile recurrence – occurring in as much as 35% of sufferers after preliminary C. difficile an infection analysis.^5,6,7 After the primary recurrence, it has been estimated that as much as 60% of sufferers might develop a subsequent recurrence.⁸

About Ferring Prescribed drugs
Ferring Prescribed drugs is a research-driven, specialty biopharmaceutical group dedicated to serving to individuals around the globe construct households and dwell higher lives. Headquartered in Saint-Prex, Switzerland, Ferring is a pacesetter in reproductive medication and maternal well being, and in specialty areas inside gastroenterology and urology. Ferring has been growing therapies for moms and infants for over 50 years and has a portfolio masking therapies from conception to start. Based in 1950, privately-owned Ferring now employs roughly 6,500 individuals worldwide, has its personal working subsidiaries in almost 60 nations and markets its merchandise in 110 nations. Study extra at www.ferring.com, or join with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

Ferring is dedicated to exploring the essential hyperlink between the microbiome and human well being, starting with the specter of recurrent C. difficile an infection. With the 2018 acquisition of Rebiotix and a number of other different alliances, Ferring is a world chief in microbiome analysis, growing novel microbiome-based therapeutics to deal with important unmet wants and assist individuals dwell higher lives. Join with us on our devoted microbiome therapeutics growth channels on Twitter and LinkedIn.

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About Rebiotix
Rebiotix Inc, a Ferring Firm, is a late-stage medical microbiome firm centered on harnessing the ability of the human microbiome to revolutionize the therapy of difficult illnesses. Rebiotix has a various pipeline of investigational drug merchandise constructed on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug applied sciences designed to probably rehabilitate the human microbiome by delivering a broad consortium of dwell microbes right into a affected person’s intestinal tract. For extra data on Rebiotix and its pipeline of human microbiome-directed therapies for various illness states, go to www.rebiotix.com, or join with us on Twitter, Facebook, LinkedIn and YouTube.

About DDW
Digestive Illness Week^® (DDW) is the most important worldwide gathering of physicians, researchers and teachers within the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgical procedure. Collectively sponsored by the American Affiliation for the Examine of Liver Illnesses (AASLD), the American Gastroenterological Affiliation (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgical procedure of the Alimentary Tract (SSAT), DDW is a totally digital assembly from Could 21-23, 2021. The assembly showcases greater than 2,000 abstracts and a whole lot of lectures on the newest advances in GI analysis, medication and expertise. Extra data will be discovered at www.ddw.org.

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Contacts

Heather Guzzi
Director, Model Communications
Communications & Digital Innovation
+1-862-286-5254
Heather.Guzzi@ferring.com

Courtney Jones
Affiliate Director, Advertising and Communications
Rebiotix Inc., a Ferring Firm
+1-651-705-8774
Courtney.Jones@ferring.com

Lindsey Rodger
Senior Supervisor, Company Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (cell)
lindsey.rodger@ferring.com