RedHill Biopharma Announces Last Patient Enrolled in the Phase III Study with RHB-104 for Crohn's Disease
GlobeNewswire•November 9, 2017
Top-line results are expected to be announced in mid-2018
The Phase III study evaluating RHB-104 for Crohn`s disease (MAP US study) is a randomized, double-blind, placebo-controlled study that is evaluating the safety and efficacy of RHB-104 in 331 subjects with moderately to severely active Crohn`s disease
Worldwide sales of Crohn`s disease therapies exceeded $7.6 billion in 2016
A pivotal Phase III study with RHB-104 for Nontuberculous Mycobacteria (NTM) infections, with Fast-Track development status, is planned to be initiated in H1/2018
TEL-AVIV, Israel and RALEIGH, N.C., Nov. 09, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the last patient has been enrolled in the Phase III study with RHB-104 for Crohn`s disease (MAP US study). Top-line results are expected to be announced in mid-2018.
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 of the MAP US study is disease remission, defined as a reduction in CDAI to less than 150 at week 26. The study enrolled 331 patients across approximately 150 clinical sites in the U.S., Canada, Europe, Israel, Australia and New Zealand.
Two pre-planned independent Data and Safety Monitoring Board (DSMB) meetings have been held to review data from the MAP US study, in which unanimous recommendations were given to continue the study without any changes to the protocol, investigator`s brochure, study conduct or informed consent form. At the first DSMB meeting, held in December 2016, safety data from the study was reviewed. At the second DSMB meeting, held in July 2017, safety and efficacy data from the first 222 subjects who had completed week 26 assessments of the study was reviewed.
In addition, an open-label extension Phase III study (the MAP US2 study) continues to evaluate the safety and efficacy of RHB-104 in subjects who remain with active Crohn`s disease (CDAI greater than or equal to 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study. These subjects have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label MAP US2 extension study. The data collected in the MAP US2 study will be supplemental to the MAP US study data. The MAP US2 study`s primary endpoint is disease remission at week 16, defined as CDAI of less than 150. The MAP US2 study is planned to enroll approximately 50-70 subjects in the U.S., Canada, Europe, Israel and New Zealand. Additional open-label studies with RHB-104 for Crohn`s disease are being planned to generate further supportive clinical data for potential future marketing applications.
Additional clinical studies are likely to be required to support a U.S. New Drug Application (NDA) for RHB-104. If the MAP US study results are positive, RedHill will meet with the U.S. Food and Drug Administration (FDA) and key opinion leaders to present the data package and discuss the preferred development path.
The worldwide sales of Crohn`s disease therapies exceeded $7.6 billion in 20161.
In addition to the ongoing Phase III studies with RHB-104 for Crohn`s disease, RedHill plans, subject to regulatory approvals, to initiate a pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria (NTM) infections in the U.S. in the first half of 2018. RHB-104 was granted Qualified Infectious Disease Product (QIDP) status by the FDA for the treatment of NTM infections. QIDP designation allows for Fast-Track development status, Priority Review of an NDA, if filed, and an additional five years of U.S. market exclusivity on top of the standard exclusivity period or Orphan Designation exclusivity period, as applicable, for a total U.S. market exclusivity of 8-12 years.
The clinical studies with RHB-104 are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institute of Health, which provides access to information on publicly and privately-supported clinical studies.
