On July 30, RedHill Biopharma announced top-line safety and efficacy results from the first Phase III study of RHB-104, a fixed dose antibiotic combination therapy of clarithromycin, clofazimine, and rifabutin, for Crohn’s disease. The development of RHB-104 is based on the idea that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection.

Although these results are the first to demonstrate the efficacy of anti-MAP therapy for the treatment of Crohn’s disease, RHB-104 will face strong competition from established biologics and nine other Phase III pipeline therapies, not to mention the continuing launch of biosimilar therapies. If anti-MAP therapy does appear to be the answer to Crohn’s disease, the question remains if RedHill will be able to establish RHB-104 in an already crowded market.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The Phase III double-blind, multicenter, parallel study enrolled 331 patients with moderately to severely active Crohn’s disease. Patients were randomised (1:1) to receive oral RHB-104 (5mg) or placebo once daily in addition to background medication including aminosalicylates, corticosteroids, immunomodulators, or anti-tumour necrosis factor biologics.

Trial results and implications for Crohn’s disease

The primary endpoint, Crohn’s Disease Active Index value of less than 150 at Week 26, was reached in a significantly greater proportion of patients receiving RHB-104 (42%) compared with placebo (29%, p = 0.013). Top-line results also showed similar rates of low adverse events between RHB-104 and placebo, suggesting RHB-104 is a safe and well-tolerated oral therapy.

Key opinion leaders interviewed by GlobalData identified the development of a safe oral therapy as a key opportunity in the Crohn’s disease market with the potential for RHB-104 to fulfil this unmet need. That being said, RHB-104 is expected to face strong competition from three other oral pipeline therapies in Phase III development: AbbVie and Galapagos/Gilead’s janus kinase inhibitors upadacitinib and filgotinib, respectively, and Celgene’s sphingosine 1-phosphate receptor 1 agonist ozanimod.

GlobalData anticipates RedHill will need to demonstrate the strong efficacy of RHB-104 in the open-label extension Phase III study and price their therapy strategically in order to compete in the Crohn’s disease market.