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JOHNE'S INFORMATION CENTER - University of Wisconsin Ñ School of Veterinary Medicine
JOHNE'S INFORMATION CENTER - University of Wisconsin - School of Veterinary Medicine




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Tuesday, July 31, 2018
MAP & Crohn’s & RedHill BioPharma – more details.

This news item provides a copy of a press release from RedHill BioPharma that gives more details about their clinical trial findings. Key findings:

  • Primary endpoint successfully achieved - superior remission rate at week 26 in patients treated with RHB-104 (p= 0.013).

  • Key secondary endpoints also met, demonstrating consistent benefit to Crohn’s disease patients treated with RHB-104.

  • Comment: The real proof is in the final peer reviewed publication: Repeating comments from the prior new item, 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.

    Press Release


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    Monday, July 30, 2018
    RedHill BioPharma has positive results from anti-MAP Crohn’s disease trial.

    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: 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.

    RedHill BioPharma


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    Tuesday, July 24, 2018
    International Guidelines to Slow MAP Spread

    [excerpt from introduction to the 16 page guidelines]
    Despite increasing understanding of MAP and paratuberculosis (Johne’s disease), little progress has been made in limiting the spread of MAP between regions and countries. MAP has been detected in most countries where it has been investigated. Regrettably, interest in MAP often only increases in countries and regions as they realize, too late, that they have endemic Johne’s disease (JD) or when another country wants to include MAP in health certification for animals or products. Knowledge gaps constraining successful control have been reviewed recently (Barkema et al, 2017).

    Article 3 of the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement, World Trade Organization, 2016) states that:

    “To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist.”

    There has also been little progress in developing and applying scientifically sound animal movement requirements for MAP. Since 2001, efforts through official channels such as OIE have not borne fruit and, for the past decade, the OIE Terrestrial Animal Health Code Chapter on Paratuberculosis has provided little guidance in this area. Concern about the low accuracy of diagnostic tests in individual animals has been a major reason that the Code chapter has not been developed further. However, the OIE Diagnostic Manual has been updated to also refer to diagnostic testing at herd-level. Herd-level testing and other certification based on large scale surveillance has been implemented for other diseases for which negative individual animal tests provide limited assurance, such as bovine brucellosis, bovine tuberculosis and the prion diseases.

    The International Association for Paratuberculosis (IAP) agreed in 2015 to develop its own guidelines for importers and exporters who want to implement rational movement requirements, based on current understanding of managing MAP risks and consistent with the principles of the SPS Agreement. These recognize and recommend risk management that is justified and appropriate for different situations. These guidelines were approved by the IAP Governing Board and full membership on June 6, 2018 in conjunction with the 14-ICP held in Riviera-Maya, Mexico.

    Comment: These IAP-approved guidelines are available on the publications page of the IAP website. This posting is to call attention to this important document.

    Guidelines for MAP certification for livestock (16 pages).


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