15 Aug Crohn’s Disease: Positive Findings from Phase III Study of Antibiotic Combination
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.
MedicalResearch.com: What are the main findings? How does RHB-104 differ from other treatments for Crohn’s (steroids, immunosuppressants etc)?
Response: RHB-104 is a patent-protected orally-administered combination of three antibiotics (clarithromycin, clofazimine and rifabutin) in a single oral capsule with potent intracellular, anti-mycobacterial and anti-inflammatory properties. As previously mentioned, the current standard of care for Crohn’s disease is limited to anti-inflammatories, immuno-suppressants and biologics, so RHB-104 has a distinct mechanism of action.
The recently reported MAP-US study demonstrated a statistically and clinically meaningful benefit to Crohn’s patients (which is on par or better when compared with leading standard of care treatments). Notably, the Crohn’s disease patients in the study were on a variety of prior standard approved therapies but had active CD nonetheless, and continued taking their background medication throughout the study. The primary endpoint was successfully achieved, with a superior remission rate at week 26 in patients treated with RHB-104 (p= 0.013). Key secondary endpoints were also met, demonstrating consistent benefit to Crohn’s disease patients treated with RHB-104. Additionally, RHB-104 was found to be generally safe and well tolerated. The results of the study suggest that RHB-104, a well-tolerated oral agent, could be an effective and safe new addition to the therapeutic options available for CD patients.
Given the limited effectiveness of standard of care treatments there is a great need for additional therapeutic options for this debilitating disease. RHB-104 shows great promise as a unique therapy which significantly benefits Crohn’s patients while maintaining an excellent safety profile.
MedicalResearch.com: What are the next stages of development of RHB-104?
Response: Additional clinical studies are most likely to be required to support a U.S. New Drug Application (NDA) for RHB-104. We plan to complete analysis of the data from our MAP-US study (including MAP status, mucosal healing, sub-populations analysis and pharmacokinetics) over the coming months and will meet with key opinion leaders and the FDA to present the data package and discuss the development path to potential approval.
We will also continue discussions with potential partners for RHB-104.
MedicalResearch.com: What should readers take away from your report?
Response: The results of the MAP US study show that RHB-104 could become a leading therapeutic option in Crohn’s disease. RedHill Biopharma is well-positioned to be a leader in the development and marketing of treatments for GI indications, with upcoming data readouts in additional GI programs. We expect top-line results from the ERADICATE Hp2 randomized, double-blind, active comparator, two-arm confirmatory phase III study with Talicia® (RHB-105) in H. pylori infections, in Q4 2018, as well as other important milestones upcoming in 2019.
MedicalResearch.com: Is there anything else you would like to add?
Response: We also plan to submit a late-breaking abstract to the American College of Gastroenterology Annual Scientific Meeting, which is in Oct 2018, and expect to present the results at additional conferences.
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