First reported by Reuters, Tel Aviv, July 30:
Israel's RedHill Biopharma said on Monday it had positive safety and efficacy results from a late-stage clinical trial with its treatment for Crohn's disease called RHB-104.
The study met its primary endpoint and key secondary endpoints, demonstrating the drug's superiority over a placebo in achieving remission of the gastrointestinal disease at week 26, the company said in a statement.
"The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo," RedHill said.
Patients treated with RHB-104 also experienced a statistically significant benefit in achieving early remission at week 16 and in durable remission over weeks 16-52.
RHB-104 was found to be generally safe and well tolerated, said the company, which is focused on proprietary drugs for gastrointestinal diseases.
"Many patients with Crohn’s disease do not achieve remission on current standard-of-care therapies, which are accompanied with poor side effects," said David Graham, lead investigator of the Phase III study.
"RHB-104 appears to have the potential to become a promising, new, orally administered therapy for this important debilitating disease."
RHB-104 is a proprietary, antibiotic combination therapy that is based on the hypothesis that Crohn’s disease is caused by a bacterial infection in susceptible patients called Mycobacterium avium subspecies paratuberculosis (MAP).
Comment [by Johnes.org; highlighting by TAFS]: If the final published results of this trial are consistent with the claims in this press release, it represents a final piece of evidence indicating that MAP is a cause of Crohn’s disease. This would heighten the need for veterinary medicine, animal agriculture, and relevant governmental agencies concerned with food safety to limit contamination of food and water by MAP.
Our long-time member Douwe Bakker was awarded the Emeritus Member Award of the International Association for Paratuberculosis at its 14th International Colloquium earlier this month in Mexico. Congratulations, Douwe! We are honored to have you in our group and look forward to you briefing us again on this important topic, together with your fellow experts Irene Grant and Mike Collins, at the next TAFS meeting.
On March 24 and 25, 2017 researchers and clinicians from around the world met at Temple University in Philadelphia to discuss the current knowledge of Mycobacterium avium ssp. paratuberculosis (MAP) and its relationship to human disease. The conference was held because of shared concern that MAP is a zoonotic bacterium that poses a threat not only to animal health but also human health.
Read the full paper here: https://www.frontiersin.org/articles/10.3389/fpubh.2017.00208/full
By categoriesPosition Papers Technical news (uncommented clippings) Technical news (commented) Official publications News on TAFS
By threadsBSE in USA
If you are not a member of the TAFS forum you may subscribe to our news stream. You will not be able to see some the news in full (for members only), but we aim to share as much as possible publicly. Just enter your email address: