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RHB-104 Plus Standard of Care Offers Extended Treatment for Crohn Disease
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The primary end point of clinical remission at week 26 was met, with 36.7% of individuals treated with RHB-104 achieving clinical remission.
New study findings from RedHill Biopharma Ltd announced positive results from its phase 3 study that displayed triple antimicrobial therapy with RHB-1041 plus standard of care (SOC) to target Mycobacterium avium subspecies paratuberculosis (MAP) was 64% more of effective at treating Crohn disease than SOC alone.1,2
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Crohn disease is an inflammatory bowel disease that causes swelling of the tissues in the digestive tract—often associated with the small intestine, which can cause abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. Common mild-to-severe symptoms include diarrhea, fever, fatigue, abdominal pain and cramping, blood in stool, mouth sores, reduced appetite, and pain or drainage near the anus.3 The study authors noted that around 1 million US adults can be impacted by the disease, resulting in a decrease in quality of life and life-threatening issues. While there is no current cure for Crohn disease, there are various available treatment options.1
“Crohn disease causes immense suffering to millions of patients globally and sometimes leads to death due to various complications. Recognizing this, RedHill is firmly committed to the RHB-104 potential paradigm-changing Phase 3-stage program. It has been more than 100 years since Scottish surgeon, Dalziel, first sowed the seeds of a possible link between MAP and Crohn. Evidence has grown of MAP involvement in the etiology of Crohn, being associated with immune signaling dysregulation and being identified in over 50% of Crohn patients,” said Dror Ben-Asher, RedHill's Chief Executive Officer, in a news release.1
RHB-104 is an oral antibiotic combination therapy, created with intracellular, antimycobacterial and anti-inflammatory properties that could serve as an additional treatment option for Crohn disease. Researchers evaluated its efficacy in a randomized, double-blind, placebo-controlled phase 3 MAP US study, as an add-on therapy to SoC treatments for Crohn disease.1
“This study was designed based on the hypothesis that infection with MAP is the primary cause of Crohn disease and that antimicrobial therapy designed to treat MAP would favorably influence the outcome of Crohn disease,” said David Y. Graham, professor of medicine and molecular virology and microbiology at Baylor College of Medicine, in a news release.1
The study included a total 331 individuals—166 were randomly assigned to receive RHB-104 with SOC and the remaining 165 received the placebo with SOC. Individuals included in the study were allowed to continue treatment with infliximab, adalimumab and/or corticosteroids, according to study authors.1
The results displayed that the primary endpoint of clinical remission at week 26 was met, as 36.7% of individuals treated with RHB-104 achieved clinical remission compared to 22.4% in the placebo group. Additionally, RHB-104 was reported to be a safe and well tolerated treatment.1
“We believe that this data shows that treatment with RedHill’s RHB-104 appears to be effective for the treatment of Crohn disease—this is important as an effective and safe oral therapy for Crohn could be highly beneficial to the patients and treating community,” said Graham in a news release. “It is therefore also important to note that RedHill’s RHB-104 proved beneficial to patients receiving corticosteroids, immunosuppressive agents, or anti-TNF agents and may also have a role as an add-on therapy for patients not responding to their current treatment.”1
References
1. Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease. RedHill Biopharma. News release. August 1, 2024. Accessed August 7, 2024. https://www.redhillbio.com/news/news-details/2024/Newly-Published-Positive-Phase-3-Data-Demonstrates-64-Increased-Efficacy-with-RedHills-RHB-104-in-Crohns-Disease/default.aspx#:~:text=(Nasdaq%3A%20RDHL)%20(%22,MAP)%2C%20is%2064%25%20more
2. Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (MAPUS). ClinicalTrials.gov. December 12, 2020. Accessed August 7, 2024. https://clinicaltrials.gov/study/NCT01951326
3. Crohn’s Disease. Mayo Clinic. News release. August 6, 2022. Accessed August 7, 2024. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
