RedHill Expands ERADICATE Study on RHB-105 for H. pylori
RedHill Biopharma Ltd. (RDHL) provided an update on the ongoing phase III study ERADICATE Hp, on pipeline candidate RHB-105, a fixed-dose combination therapy for Helicobacter pylori infection (H. pylori).
RedHill is now expanding the study to include additional subjects and clinical sites for better statistical powering and to expedite recruitment, respectively.
Based on prior discussions with the FDA, RedHill is now evaluating RHB-105 for the first line treatment of H. pylori infection irrespective of the ulcer status.
As per RedHill, the current standard treatments for H. pylori infection are approved to treat patients with only active or recent history of ulcers.
Consequently, RedHill has increased the number of subjects to be enrolled from 90 to 120 for the ERADICATE Hp study as a larger population will improve the study's statistical powering and reduce the potential impact of non-compliant subjects in meeting the primary endpoint of H. pylori eradication. RedHill is also increasing the total number of clinical sites to 12 from 8 in order to expedite recruitment.
The top line data from the study is expected to come out in the first half of 2015.
Moreover, under the Generating Antibiotic Incentives Now (GAIN) Act, H.pylori has been added to the FDA’s list of qualifying pathogens. Subsequently, new drugs indicated to treat H. pylori may be designated as a Qualified Infectious Diseases Product (:QIDP) and will be entitled for additional five years of exclusivity, along with fast track status and priority review by the FDA.
RedHill also plans to conduct a confirmatory phase III study to support its NDA filing for RHB-105. Hence, the successful development and commercialization of RHB-105 will be a significant boost for RedHill.
RedHill Biopharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader healthcare sector include Gilead Sciences (GILD), Allergan (AGN) and Regado Biosciences, Inc. (RGDO). All three sport a Zacks Rank #1 (Strong Buy).
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