RedHill Biopharma to Host Investor Webcast on RHB-104 for Crohn’s Disease on May 15
- Last patient completed treatment for primary endpoint assessment in the Phase III study with RHB-104 for Crohn’s disease; Top-line results expected to be announced in approximately 3 months
Members of RedHill’s executive team will be joined by key opinion leaders who will discuss RHB-104, the MAP US study, Crohn’s disease, the current treatment landscape and potential market. A question and answer session will be held following the presentations.
The webcast, including a slide presentation, will be broadcasted live and available for replay on the Company's website, http://ir.redhillbio.com/events, for 30 days. Please access the website at least 15 minutes ahead of the conference call to register, download, and install any necessary audio software.
Participants who wish to ask questions during the live Q&A can do so by telephone. To access the event by telephone, please dial one of the following numbers 5-10 minutes prior to the start of the call:
The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in subjects with moderately to severely active Crohn’s disease (defined as Crohn’s Disease Active Index (CDAI) between 220 and 450). The primary endpoint is disease remission, defined as CDAI value of less than 150 at week 26. The study has enrolled 331 patients across clinical sites in the U.S.,
RedHill recently announced that the last patient enrolled in the first Phase III study with RHB-104 for Crohn’s disease (the MAP US study) has completed 26 weeks of treatment for primary endpoint evaluation. Top-line results are expected to be announced in approximately three months.
Currently in a first Phase III study for the treatment of Crohn’s disease (MAP US study), with top-line results expected in mid-2018, RHB-104 is a potentially ground-breaking, proprietary, orally-administered antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology. An independent Data and Safety Monitoring Board (DSMB) held two pre-planned meetings and unanimously recommended to continue the MAP US Phase III study, with no safety concerns. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. Additionally, an open-label extension Phase III study (MAP US2 study) is ongoing to assess the safety and efficacy of RHB-104 in subjects who have completed week 26 assessments in the ongoing Phase III MAP US study and remain with active Crohn’s disease (CDAI ≥ 150). Additional clinical studies are likely to be required to support a U.S. NDA for RHB-104, if filed. RHB-104 is covered by several issued and pending patents. RHB-104 was granted Qualified Infectious Disease Product (QIDP) designation by the U.S.
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Senior VP Business Development & Licensing
Source: RedHill Biopharma Ltd.