Author Interviews, Biomarkers, Gastrointestinal Disease / 28.03.2020

MedicalResearch.com Interview with: Jean-Frederic Colombel MD The Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sina New York, NY 10029, USA MedicalResearch.com: What is the background for this study? Response: The goals of therapy in Crohn’s disease have shifted from mere control of symptoms also called clinical remission towards combination of clinical and endoscopic remission also called deep remission which is now considered as the new therapeutic “target”. However it has yet to be proven that targeting deep remission instead of clinical remission is able to stop the progression of Crohn’s disease towards bowel damage, complications and hospitalizations. This study is a post-hoc analysis of the CALM trial that was published in The Lancet in 2018 where newly diagnosed patients were randomized to escalate therapy based on symptoms only (control arm) or based on a combination of symptoms and two biomarkers namely C-reactive protein in blood and calprotectin in stools (tight control arm). (more…)
Author Interviews, Dermatology, Gastrointestinal Disease, JAMA / 11.07.2019

MedicalResearch.com Interview with: Prof Ching-Chi Chi, MD, MMS, DPhil (Oxford) Department of Dermatology Chang Gung Memorial Hospital, Linkou Guishan Dist, Taoyuan 33305 Taiwan MedicalResearch.com: What is the background for this study? Response: Hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD) are inflammatory diseases that share common clinical manifestations, genetic susceptibility, and immunologic features. For example, both diseases have similar clinical manifestations in the skin and gut, characterized by sterile abscesses in perineal and inguinal areas, scarring, and sinus tract formation. Both diseases have been associated with an increased prevalence of spondyloarthropathy, have common risk factors (smoking and obesity), and respond well to tumor necrosis factor-inhibitors. Some studies have suggested a link between HS and IBD, but data on the association of HS and IBD remain inconsistent and unclear. Therefore, we conducted a meta-analysis to investigate the association of hidradenitis suppurativ with IBD. (more…)
Author Interviews, Gastrointestinal Disease, Probiotics / 11.04.2019

MedicalResearch.com Interview with: Professor Mahmoud A. Ghannoum, PhD Director of the Center for Medical Mycology Case Western Reserve School of Medicine and UH MedicalResearch.com: What are the main findings?  Response: The driving force for this study was our finding that patients with Crohn’s disease had a significantly high level (or abundance) of pathogenic fungi (called Candida tropicalis) as well as bacteria (Escherichia coli, and Serratia Marcescens) compared to their non-diseased first-degree relatives. Not only were their levels high, but these organisms cooperated to form polymicrobial digestive plaque (or digestive biofilms) that aggravated the inflammatory symptoms in these patients. Based on this we wanted to develop a probiotic that targeted these organisms and the biofilms they form. Our efforts led to the design of the novel Biohm probiotic which we tested and the results were described in our publication. (more…)
Author Interviews, Gastrointestinal Disease / 03.11.2018

MedicalResearch.com Interview with: RedHill BiopharmaDror Ben-Asher Co-Founder, Chairman & CEO RedHill Biopharma Ltd. MedicalResearch.com: Your presentation at United European Gastroenterology Week (UEGW) covered top-line data from your recently completed Phase 3 study of RHB-104 in Crohn’s disease. Can you please briefly remind us of the background for this study and what results you previously announced? Response: Crohn's disease is a devastating gastrointestinal disorder that affects millions of people worldwide. Crohn's is a chronic relapsing disorder that plagues people throughout their lives with a variety of symptoms including severe abdominal pain, diarrhea, bleeding, bowel obstruction, fever and weight loss. The existing treatments for Crohn's disease leave a lot to be desired – they are only partially effective in the long-term control of Crohn's and are associated with serious side effects. In addition, the existing therapies only target treating the symptomatic inflammation associated with Crohn's. We began developing RHB-104 with the MAP hypothesis in mind, a theory that suggests Crohn's is caused by infection by a bacteria, Mycobacterium avium subspecies paratuberculosis (MAP), in susceptible patients. RHB-104 is a patent-protected orally-administered combination of three antibiotics (clarithromycin, clofazimine and rifabutin) in a single oral capsule that has demonstrated its potential to benefit Crohn's patients. When we announced top-line results from the MAP US study, our Phase 3 trial of RHB-104 in patients with moderate to severe Crohn's disease, we showed that RHB-104 demonstrated a significant clinical benefit to patients versus placebo control. Patients treated with RHB-104 showed significant increase in remission at 26-weeks post treatment initiation in addition to being generally safe and well tolerated. (more…)
Author Interviews, Gastrointestinal Disease, Pharmaceutical Companies / 15.08.2018

MedicalResearch.com Interview with: RedHill Biopharma LtdMr. Gilead Raday, MPhil, MSc Chief Operating Officer RedHill Biopharma Ltd MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Crohn's disease?  How common is it and whom does it affect?  Response: Crohn's disease (CD) is a chronic, relapsing inflammatory gastrointestinal disorder characterized by a variety of symptoms, including severe abdominal pain, diarrhea, bleeding, bowel obstruction, fever and weight loss. The underlying cause of Crohn's is unknown; however, CD is believed to arise secondary to genetic and environmental stimuli. More than 1.5 million people suffer from CD globally and it is prevalent in the U.S., affecting more than 200 people per 100,000. The current standard of care for Crohn's disease is limited to anti-inflammatories, immuno-suppressants and biologics that treat auto-immune disorders. These therapies target symptomatic improvement in the inflammation associated with CD, are widely considered to be of limited efficacy in the long term, and are associated with numerous side effects. This speaks to the great unmet need for an effective therapy for this debilitating disease. Additionally, there is no current therapy that treats the suspected underlying cause of Crohn’s disease. We have developed RHB-104 with the MAP hypothesis in mind, which posits that Crohn's disease is caused by infection by a bacteria, Mycobacterium avium subspecies paratuberculosis (MAP). This is similar to peptic ulcer disease, a condition that was initially associated with stress, smoking, NSAIDs and other behavioral factors, yet was found to be caused by H. pylori bacterial infection in the 1980s, revolutionizing the field of ulcer treatment. Validation of this theory would revolutionize how Crohn's disease is viewed and treated by the medical community and RHB-104 is the only therapy in development targeting MAP infection.  (more…)
Author Interviews, Gastrointestinal Disease, Infections, PLoS / 10.10.2016

MedicalResearch.com Interview with: Brian K. Coombes, PhD Professor & University Scholar Associate Chair, Graduate Education Department of Biochemistry & Biomedical Sciences Assistant Dean, Biochemistry Graduate Program Canada Research Chair in Infectious Disease Pathogenesis MedicalResearch.com: What is the background for this study? Response: North Americans have among the highest reported prevalence and incidence of inflammatory bowel disease (IBD) in the world. This is a lifelong disease that often strikes people in their early years, leading to decades of suffering, increased risk of colorectal cancer, and 50% increased risk of premature death. Compared to the general population, quality of life for those with Crohn’s disease is low across all dimensions of health. The need to understand the root origins of this disease and to use this information to invigorate a new pipeline of treatments and preventions has never been more pressing. (more…)