Category Archives: Clinical Trials

Summit Therapeutics IDWeek 2021 E-Poster Provides Enhanced Details About the Newly Discovered Novel Mechanism of Action of Ridinilazole

Summit Therapeutics Inc.is today displaying an important e-Poster at IDWeek 2021. IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).

Summit’s e-Poster provides enhanced details regarding the newly discovered novel mechanism of action of ridinilazole. The e-Poster will be available throughout IDWeek 2021, which takes place between September 29 and October 3, 2021.

Ridinilazole is Summit Therapeutics’ investigational first-in-class drug that recently completed enrollment of a Phase III clinical trial, Ri-CoDIFy. The primary endpoint of this trial seeks to demonstrate the superiority of ridinilazole in sustained clinical response as compared to vancomycin. Ridinilazole is not currently approved for use by any regulatory authority.

Summit’s poster presentation provides demonstrable scientific evidence of ridinilazole’s novel mechanism of action which involves binding to the minor groove of Clostridioides difficile bacteria’s DNA (the minor groove is a location on the helix of the bacteria’s DNA to which a drug can attach or bind). This is believed to be the primary mechanism through which ridinilazole elicits its bactericidal action against C. difficile bacteria. Ridinilazole has a novel mechanism of action and is the first of a new class of antibiotics: this is consistent with the World Health Organization’s (WHO) recommendation for developing antibiotics with novel mechanisms of action or that are new classes of drugs, which it considers a key point in overcoming existing bacterial resistance.1

Our updated research, through collaboration with the University of Houston, provides new images from high-resolution confocal microscopy. This technique has allowed intracellular visualization of ridinilazole binding to DNA within C. difficile and confirms this novel mechanism of action. Ridinilazole, if approved, has the potential to be the first antibiotic with a novel mechanism of action approved in over ten years.

The poster is available within the “Scientific Literature & Publications” section of our website: https://www.summittxinc.com/publications/.

About Summit Therapeutics

The overriding objective of Summit Therapeutics is to create value for patients, hospital caregivers, and community-based healthcare providers, as well as healthcare payers around the world. We seek to create value by developing drugs with high therapeutic efficacy – curing the cause of the patient’s condition with minimal or zero disease recurrence or antimicrobial resistance, for the longest extent possible – and minimizing the trauma caused to the patient and healthcare ecosystem by minimizing serious side effects, disease recurrence, and inaccessibility to our treatments as a result of financial or other barriers. Summit Therapeutics, empowered by its Discuva Platform, the Company’s innovative antibiotic discovery engine, and supported by BARDA and CARB-X funding, intends to be the leader in patient-friendly and paradigm-shifting treatments for infectious diseases and other significant unmet medical needs while being an ally to physicians. Our new mechanism pipeline product candidates are designed with the goal to become the patient-friendly, new-era standard of care, by working in harmony with the human microbiome to treat prospective patients suffering from infectious diseases, initially focusing on Clostridioides difficile infection (CDI). Currently, Summit’s lead product candidate, ridinilazole, is a novel, first-in-class drug engaged in a global Phase III trial program versus vancomycin, for use as first-line therapy for the treatment of initial and recurrent Clostridioides difficile infection, and to show superiority in sustained clinical response. Commercialization of ridinilazole is subject to regulatory approvals. SMT-738, the second candidate within Summit’s portfolio, is currently in the IND-enabling phase for the treatment of multidrug resistant infections, specifically those caused by carbapenem-resistant Enterobacteriaceae (CRE).

To read the press release in its entirety, please click on the following link to be redirected.

Thank you.

SOURECE:  https://www.summittxinc.com/app/uploads/2021/09/2021_PR_0930_ID-Week-Presentation-_-FINAL.pdf

Acurx Pharmaceuticals Presents Abstract and Poster Presentation at IDWeek: New Microbiome Data from Its Phase 2a Clinical Trial of Ibezapolstat for C. difficile Infections


Acurx Pharmaceuticals, Inc.  a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that a scientific abstract and poster presentation will be given at the Infectious Disease Society of America (IDSA) IDWeekTM 2021, taking place virtually from September 29 – October 3, 2021:

Title: An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective
Spectrum (GPSS) Antibiotic, for Patients with Clostridioides difficile Infection
Presenting Author: Professor Kevin Garey, PharmD, MS, University of Houston
Date: Wednesday, September 29, 2021 through Sunday, October 3, 2021
Poster Session: Enteric Infections
Poster Number: 701

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate of two of the three antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in Clostridioides difficile Infection (CDI)
C. difficile can sometimes be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

About the Ibezapolstat Phase 2 Clinical Trial.
The multicenter, open-label single-arm segment of this study (Phase 2a) is to be followed by a double- blind, randomized, active-controlled segment (Phase 2b) which, together, comprise the Phase 2 clinical trial. The Phase 2 clinical trial is designed to evaluate ibezapolstat in the treatment of CDI. Phase 2a of this trial is completed and was an open-label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment, the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study. Based on the recommendation of Acurx’s Scientific Advisory Board (SAB) and Trial Oversight Committee, we terminated enrollment in Phase 2a early and are now advancing to Phase 2b. The SAB unanimously supported the early termination of the Phase 2a trial after 10 patients were enrolled in the trial instead of 20 patients as originally planned. The early termination was based on the evidence of meeting the primary and secondary endpoints of eliminating the infection (100%), with no recurrences of infection (100%), and with an acceptable adverse event profile. In the upcoming Phase 2b, approximately 64 additional patients with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments will be identical in appearance, dosing times, and number of capsules administered to maintain the blind. This Phase 2 clinical trial will also evaluate pharmacokinetics (PK) and microbiome changes and continue to test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy.

About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company’s approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit http://www.acurxpharma.com.

Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other factors. In addition, the forward-looking statements included in this press release represent our views as of September 27, 2021. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward- looking statements at some point in the future, we specifically disclaim any obligation to do so.

 

SOURCE:  https://www.acurxpharma.com/news-media/press-releases/detail/27/acurx-announces-new-microbiome-data-from-its-phase-2a

Seres Therapeutics Announced Data From Its Phase 3 ECOSPOR III Study Evaluating SER-109, An Investigational Oral Microbiome Therapy For Recurrent C. diff. (C. difficile) Infection

Seres Therapeutics, Inc.  a leading microbiome therapeutics company, today announced data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapy for recurrent C. difficile infection (rCDI), will be presented at the IDWeek 2021 Virtual Conference
(Sept. 29-Oct. 3). The Company will be presenting seven posters and oral presentations related to SER-109 and C. difficile, including a late-breaker, as well as an oral presentation on SER-155, an investigational cultivated microbiome therapeutic entering clinical development designed to reduce the risk of gastrointestinal antibiotic-resistant bacterial infections, bacteremia and graft-versus-host-disease (GvHD) in immunocompromised patients.

Notably, exploratory analyses of SER-109 data revealed that SER-109 was associated with improved overall and mental health scores compared to baseline regardless of clinical outcome, as measured by CDiff32 (presenting author: Kevin Garey, PharmD, M.S.). Another poster highlights that despite more than half of the patient population in ECOSPOR III having at least one co-morbidity, SER-109 was observed to significantly reduce the incidence of recurrence compared to placebo in these patients. SER-109 was observed to reduce CDI recurrence among patients at risk for recurrence because of age, gender, proton pump inhibitor use, and/or co-morbidities such as diabetes, cardiac disease and malignancy, in comparison to placebo (presenting author: Stuart Cohen, M.D.).

“The data we’re presenting at IDWeek 2021 further validates the strength of our investigational microbiome pipeline as we urgently work to address the unmet treatment needs for both recurrent C. difficile infection and immunocompromised patients,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “We believe microbiome therapeutics have the potential to target multiple disease pathways and offer new, potentially transformative treatment options for patients in need.”

The oral presentation by Elizabeth Halvorsen, Ph.D. on SER-155, an investigational cultivated microbiome therapeutic, will highlight preclinical data showing that SER-155 can decolonize antibiotic-resistant pathogens (VRE: vancomycin-resistant Enterococcus faecium and CRE: carbapenem-resistant Klebsiella pneumoniae); potentially reducing the risk of subsequent infection.

In addition, Seres is presenting the following SER-109-related posters and a late-breaker presentation at IDWeek 2021:

SER-109, an Investigational Microbiome Therapeutic, Reduces Abundance of Antimicrobial Resistance Genes in Patients with Recurrent Clostridioides difficile Infection (rCDI) after Standard-of-Care Antibiotics, Saturday, October 2, 1:15 PM – 3:00 PM ET, Presenting Author: Timothy Straub (late-breaker)

Manufacturing Processes of SER-109, a Purified Investigational Microbiome Therapeutic, Reduce Risk of Transmission of Emerging and Undetected Infections in Donor Stool, Presenting Author: Christopher McChalicher

Diagnostic Testing Among Patients with Suspected Recurrent Clostridioides difficile Infection (rCDI) in ECOSPOR III a Phase 3 Clinical Trial: Implications for Clinical Practices vs Clinical Trials, Presenting Author: Matthew Sims

Time to Recurrence of Clostridioides difficile Infection (rCDI) is Rapid Following Completion of Standard of Care Antibiotics: Results from ECOSPOR-III, a Phase 3 Double-Blind, Placebo-Controlled Randomized Trial of SER-109, an Investigational Microbiome Therapeutic, Presenting Author: Thomas Louie

The Burden of Illness Associated with Recurrent Clostridioides difficile Infection: A Claims-based Analysis, Presenting Author: Rachel Black

In addition, Paul Feuerstadt, M.D. will be providing a sponsored talk on Friday, October 1 at 2:00-2:45 PM ET, entitled “Perspectives on the Pathogenesis of Recurrent Clostridioides difficile Infection: Insights into Microbiome Science.”

The data is available to registered attendees on the virtual platform throughout the duration of the IDWeek Conference at http://www.IDWeek.org.

About SER-109

SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in the healthy microbiome. SER-109 is designed to prevent further recurrences of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes thereby reducing the risk of pathogen transmission beyond donor screening alone. The U.S. FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of rCDI.

About SER-155

SER-155, an oral consortium of cultivated bacteria, is a microbiome therapeutic candidate intended to advance into clinical development. SER-155 is designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models, with the aim to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD. The rationale for this program is based in part on published clinical evidence from Seres’ collaborators at Memorial Sloan Kettering Cancer Center showing that allogeneic hematopoietic stem-cell transplantation (HSCT) patients with decreased diversity of commensal microbes are significantly more likely to die due to infection and/or GvHD. SER-155 was developed using Seres’ reverse translational discovery platform to reduce morbidity and mortality due to gastrointestinal infections, bacteremia and GvHD in immunocompromised patients, including in patients receiving allogeneic HSCT or solid organ transplants.

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a leading microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 in a Phase 1b study to address gastrointestinal infections, bacteremia and graft-versus-host disease. For more information, please visit http://www.serestherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the potential approval of SER-109 and its status as a first-in-class therapeutic, the timing of a BLA filing, the ultimate safety profile of SER-109, the ultimate market for SER-109, the potential for microbiome therapeutics to improve the outcome of immunocompromised patients, the ability of SER-109 to improve rCDI patients’ quality of life, the potential of microbiome therapeutics to treat and prevent disease, the timing and results of our clinical studies, the benefits of our collaborations, the ultimate safety and efficacy data for our products, and other statements which are not historical fact.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on August 3, 2021, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 

Source:  https://ir.serestherapeutics.com/news-releases/news-release-details/seres-therapeutics-presents-data-supporting-its-microbiome

Ferring Pharmaceuticals and Rebiotix, a Ferring Company, Announced Final Results of An Analysis From Five Prospective Trials Of Its Investigational Microbiota-Based Live Biotherapeutic RBX2660

Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced final results of an analysis from five prospective trials of its investigational microbiota-based live biotherapeutic, RBX2660, for the reduction of recurrent C. difficile infection (rCDI). The abstract, presented at IDWeek 2021, represents the first time these data are showcased together, and is one of only four abstracts to receive the Program Committee Choice award for outstanding scientific research.

“For years, people with recurrent C. difficile infection haven’t had an available, standardized treatment option to break the cycle of recurrence or clinically address the health of their gut microbiome composition that puts them at risk for this highly communicable disease, and they still do not,” said Teena Chopra, MD, MPH, Professor of Medicine, Division of Infectious Disease, Wayne State University School of Medicine. “The important data from the Ferring microbiome-based biotherapeutic trials provide a significant milestone for the C. difficile community to hopefully one day have an improved treatment option for patients suffering from this disease.”

Across the five prospective trials, which included 723 actively-treated participants, RBX2660 consistently reduced the recurrence of CDI, with up to 78.9% remaining recurrence-free for eight weeks post treatment (defined as treatment success). Among participants who did not respond to initial treatment, an optional additional treatment course was administered, resulting in overall rates of treatment success of up to 84.4%. Notably, most primary responders remained CDI-free for six months and up to two years, with a sustained clinical response success rate of up to 92.1% in the Phase 3 program.

These data provide the totality of evidence culminating in over a decade’s worth of work that demonstrates a consistent efficacy profile for RBX2660, and importantly, a consistent safety profile across five prospective trials,” said Lindy L. Bancke, PharmD, Head of Clinical Development at Rebiotix, who presented the research. “They reinforce the enormous potential of microbiome-based therapeutics to transform the care of people suffering from rCDI.”

This analysis included three Phase 2 (PUNCH CD, PUNCH CD2, PUNCH CD Open Label) and two Phase 3 trials (PUNCH CD3, PUNCH CD3-OLS ad hoc analysis). All participants were ages 18 or older who had at least one recurrence after a primary episode of CDI and had completed at least one round of standard-of-care oral antibiotic therapy. According to a separate presentation on safety, RBX2660 demonstrated a consistent safety profile across all five clinical studies. The percentage of participants reporting a treatment-emergent adverse event (TEAE) in the RBX2660 group was similar to the group receiving the standard-of-care plus placebo. Most TEAEs were mild or moderate in severity, and no potentially life-threatening TEAEs were considered related to RBX2660.

A third abstract showed that, among treatment responders in the PUNCH CD3 trial, RBX2660 significantly increased gut bacteria associated with health and decreased gut bacteria associated with CDI pathology within seven days, maintaining that effect for up to six months following treatment. Specifically, RBX2660 demonstrated an increase in the relative abundance of two important classes of beneficial bacteria – Bacteroidia and Clostridia – and reduced relative abundance of classes that could be considered harmful, Gammaproteobacteria and Bacilli.

“C. difficile infection often is marked by a vicious cycle of recurrence, wherein patients’ infection may return within days after antibiotic treatment. This can significantly impact a person’s health and well-being, and burden the healthcare system,” said Ken Blount, PhD, Chief Scientific Officer at Rebiotix and a study presenter. “The shift of the microbiome observed in our study provides the first evidence linking Phase 3 efficacy data of RBX2660 with improved microbiota composition of the gut. This finding is important, as this is during a time when a person recovering from CDI is most vulnerable for reinfection, and these changes were durable for at least six months.”

Additional evidence from the PUNCH CD3 trial, presented in two separate abstracts, demonstrated important potential benefits that may contribute to the therapeutic efficacy seen in the clinical program. In the trial, RBX2660 appeared to remove potentially deadly antimicrobial resistant (AMR) bacteria from the gut microbiota, as researchers found that the total number of AMR genes in participants receiving RBX2660 decreased significantly after treatment and remained low for at least six months. Colonization of AMR pathogens in the gut is a known risk factor for infection and common among people with recurrent CDI. The PUNCH CD3 analysis also showed that RBX2660 treatment responders exhibited reduction in primary bile acids, known to trigger CDI spore germination, and increase secondary bile acids, known to inhibit spore germination and growth.1

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).2 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.2,3,4

C. difficile infection often is the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.5,6 Up to 35% of CDI cases recur after initial diagnosis7,8 and people who have had a recurrence are at significantly higher risk of further infections.9,10,11,12 After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.13

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.7,8,14

Restoring the gut microbiome is increasingly accepted as a promising treatment option for recurrent C. difficile infection.15

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.

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,

About IDWeek

IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). More information can be found at www.idweek.org.

References:

  1. Winston, Jenessa A, and Casey M Theriot. “Impact of microbial derived secondary bile acids on colonization resistance against Clostridium difficile in the gastrointestinal tract.” Anaerobe vol. 41 (2016): 44-50. doi:10.1016/j.anaerobe.2016.05.003
  2. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
  3. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.
  4. Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
  5. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
  6. Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
  7. 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.
  8. Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154–61.
  9. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
  10. 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.
  11. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
  12. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
  13. Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.
  14. 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.
  15. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficileN Engl J Med. 2013;368(5):407-415.

SOURCE:  https://www.businesswire.com/news/home/20210929005597/en/%A0Ferring-Presents-Complete-Data-across-Five-RBX2660-Trials-Demonstrating-Consistent-and-Durable-Efficacy-in-Recurrent-C.-Difficile-Infection-as-Well-as-Multiple-Analyses-Demonstrating-Positive-Shifts-in-Microbiome-Properties

C. diff. Spores and More Live Broadcast to Podcast Is Available: Prevent CDI: Boost Immunity, Restore Microbiome, Replace the Bug

 

We are pleased to share  “C. diff. Spores and More ”  with you because, as advocates of  C. diff.,  we know the importance of this cutting-edge new weekly radio show and what it means for our Foundation’s community worldwide.

 

 

July 20, 2021:  Prevent CDI: Boost Immunity, Restore Microbiome, Replace the Bug

With Guests:

Neil Clark, Chief Executive Officer, Destiny Pharma, PLC

Mr. Clark qualified as an accountant with PwC in Cambridge, UK and worked for over ten years on a variety of national and international assignments in audit, corporate finance and consultancy. In 1997, Mr Clark joined CeNeS Pharmaceuticals plc, a venture capital backed private UK biotech company. Following the successful flotation of CeNeS in 1999, he was appointed CFO. In 2005, he became CEO and led the company through to its sale in 2008. He then joined Ergomed in January 2009 and was CFO during its IPO in July 2014. Mr. Clark joined Destiny Pharma as CEO in early 2017. Mr. Clark is a Fellow of the Institute of Chartered Accountants in England and Wales and has a BSc in Bioscience from the University of Nottingham.

Dale Gerding, MD, FACP, FIDSA, FSHEA

Dr. Dale Gerding is Research Physician at the Edward Hines Jr. VA Hospital and Professor of Medicine (Retired) at Loyola University Chicago Stritch School of Medicine. He is an infectious diseases specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America. He is a fellow of the Infectious Diseases Society of America, is a Master of the American College of Physicians and the 2013 recipient of the William Middleton Award, the highest research award given by the Department of Veterans Affairs. He is board certified in Internal Medicine and Infectious Diseases. His major research interest is in the epidemiology, prevention and treatment of Clostridioides difficile infection and he is the discoverer of non-toxigenic C. difficile strain M3. (NTCD-M3)

https://www.voiceamerica.com/episode/132305/prevent-cdi-boost-immunity-restore-microbiome-replace-the-bug

Neil Clark, Chief Executive Officer, Destiny Pharma PLC and Dale Gerding, MD, FACP, FIDSA, FSHEA, with our Guest Host: Kevin Hersh, shared a robust discussion which touched upon important topics focused on the what, why, and how to Prevent a C. diff. infection: Boost Immunity, Restore Microbiome, Replace the Bug. Our guests exchanged a dialogue about the science to answer the many questions about a C. difficile infection, prevention, treatments, what is recurrent C. diff., and the immune system, and how the microbiome plays a part in everything.  Click on the link provided above to access the archived episode and expand your basic CDI knowledge today.