RedHill Biopharma

Crohn’s Disease: Single Capsule Antibiotic Combined Demonstrates Clinical Benefit Interview with:
RedHill BiopharmaDror Ben-Asher
Co-Founder, Chairman & CEO
RedHill Biopharma Ltd. 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. What are the new findings presented at UEGW?

Response: The new findings presented at the United European Gastroenterology Week conference were three-fold.

First, we reported enhanced p-values for some of the primary and secondary endpoints originally reported from the MAP US Study in July due to a stratified group analysis that was prespecified in the trial protocol.

Second, and more important, were the findings that RHB-104 demonstrated a consistent and clinically significant benefit in the subgroups of patients receiving current standard of care therapies (immunomodulators, corticosteroids and anti-TNF agents). Since patients in the MAP US trial were allowed to stay on their existing treatment regimen during the trial we were able to demonstrate that RHB-104 was effective over and above the current standard of care for Crohn’s.

We also introduced new data about endoscopic evaluation of inflammation, and showed that despite the small number of patients in the study who were endoscopically evaluated, RHB-104 showed a clinically and statistically meaningful benefit to reducing endoscopically evaluated inflammation. What are the implications of the new data presented at UEGW?

Response: The new data expands upon and strengthens the primary and secondary endpoints previously reported. It demonstrates the consistency of a meaningful benefit to Crohn’s patients on top of and across the major standard of care treatments (immunomodulators, anti-TNF and corticosteroids), and speaks to the diverse possibilities of combining RHB-104 with all the major therapeutic alternatives currently administered, and to the clear positive impact this has on these patients’ well-being.

In addition, the reported endoscopic results fortify and confirm the clinical benefit reported, using a method that is becoming the standard approach to the way Crohn’s disease is being evaluated.

Taken together, the robust and consistent benefit of RHB-104 demonstrated in the study, together with the excellent safety profile and it being an oral therapy with a distinct mechanism of action, speak to the potential for RHB-104 to make a significant impact on the Crohn’s therapy market, both as a first-line therapy and as a combination therapy given with existing medications. What are the next steps for the RHB-104 program? 

Response: We are still in the process of analyzing the large dataset provided by the MAP US study. These ongoing analyses will continue to evaluate subgroups, biomarkers, MAP status and pharmacokinetics. We are also planning on initiating discussions with the FDA to discuss next steps and plans for design of another Phase 3 trial that we hope will be sufficient for the filing of a NDA, if completed successfully. Our goal is to try and bring this new therapy to the market to help all those suffering from Crohn’s disease as soon as is possible. Is there anything else that you’d like to add?

Response: We have recently completed treatment of the last patient in our pivotal Phase 3 trial with Talicia®, for the eradication of H. pylori infections. H. pylori infection is a major worldwide health problem, recently being characterized by the WHO as a pathogen for which there is a “High Priority” need to develop new treatments.

Pylori is one of the most successful human pathogens, being found in almost half of the world’s population. People infected with H. pylori can suffer from gastritis and have an increased risk of developing ulcers and gastric cancers. Due to an increase in bacterial resistance, the effectiveness of current treatments for H. pylori infection has decreased and new treatment options are needed.

Our developmental therapy, Talicia, is being tested in dyspepsia patients who are H. pylori positive as part of the “test and treat” strategy, a new medical practice of preemptively eradicating the infection in anyone with symptoms of dyspepsia. H. pylori infection is a multi-billion dollar market worldwide and we are hoping the upcoming data show significant benefit of Talicia versus current therapies such that we can use this therapy to treat a large portion of the world’s population affected by this dangerous pathogen.

The top-line data for the Phase 3 trial of Talicia for H. pylori infections should be released before year’s end, hopefully with ensuing NDA filing and product launch expected in 2019. So stay tuned for this important upcoming milestone.

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Nov 4, 2018 @ 12:14 am

1. An abstract discussing the study’s top-line results, ‘A Phase III Randomized, Double Blind, Placebo-Controlled, Multicenter, Parallel Group Study To Assess The Efficacy And Safety Of Add-On Fixed-Dose Anti-Mycobacterial Therapy (RHB-104) In Moderately To Severely Active Crohn’s Disease (MAP US)’ was presented as a late-breaking abstract today at the United European Gastroenterology Week (UEG Week 2018) by Dr. David Y. Graham, M.D., Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine, Houston and Lead Investigator of the MAP US study.

2. These data  are follow-up data to their RHB-104 study findings published on July 30, 2018  and covered on here:

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