RedHill Biopharma Announces Allowance of Two New RHB-104 Patents Ahead of Top-Line Phase III Results for Crohn’s Disease
RedHillhas received Notices of Allowance for two new patents covering RHB-104 in the U.S. and Europewhich are expected to be valid until at least 2029, once granted
- Top-line results from the first Phase III study with RHB-104 for Crohn’s disease are expected to be announced in the coming weeks
- RedHill’s robust RHB-104 patent portfolio is comprised of 30 patents worldwide, including five patents in the U.S., with additional patent claims being pursued
- Worldwide sales of Crohn’s disease therapies are estimated to exceed
$10 billionin 2018
RHB-104 is a potentially ground-breaking, proprietary, orally-administered antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. The development of RHB-104 for Crohn’s disease is based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.
RedHill’s robust patent portfolio covering RHB-104 is comprised of 30 patents in many countries, including five patents in the U.S., with additional patent claims being pursued.
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.,
An independent Data and Safety Monitoring Board (DSMB) held two pre-planned meetings and unanimously recommended to continue the study, with no safety concerns. The first DSMB meeting reviewed safety data from the study and the second DSMB meeting reviewed safety and efficacy data from the first 222 subjects who had completed week 26 assessments of the study.
In addition, an open-label extension Phase III study (MAP US2 study) is ongoing to evaluate the safety and efficacy of RHB-104 in subjects who remain with active Crohn’s disease (CDAI ≥ 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study.
Additional clinical studies are most likely to be required to support a U.S. New Drug Application (NDA) for RHB-104, if filed. If the MAP US study results are positive,
Approximately 1.5 million people were diagnosed with Crohn's disease worldwide in 20171. Worldwide sales of Crohn’s disease therapies are estimated to exceed
The MAP US Phase III study is registered on www.ClinicalTrials.gov, a web-based service of the
Currently in a first Phase III study for the treatment of Crohn’s disease (MAP US study), with top-line results expected in the coming weeks, 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.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the new patents will not be valid until the dates expected, that the top-line results of the Phase III study with RHB-104 will be later than expected or that worldwide sales of Crohn's disease will not reach the amount currently estimated and risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully promote Donnatal® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mgand commercialize EnteraGam®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the
Senior VP Business Development & Licensing
| IR contact (U.S.):
Timothy McCarthy, CFA, MBA
Managing Director, Relationship Manager
LifeSci Advisors, LLC
1 GlobalData PharmaPoint: Crohn's Disease - Global Forecast 2016–2026,
2 GlobalData PharmaPoint: Crohn's Disease - Global Forecast 2016–2026, September 2017.
Source: RedHill Biopharma Ltd.