Amoxicillin + omeprazole + rifabutin

Articles · New Medicines ·
27658006

Articles

New Medicines

Talicia · Helicobacter pylori bacterial infection - first-line

Information

Talicia
New formulation
RedHill Biopharma Ltd
RedHill Biopharma Ltd

Development and Regulatory status

None
None
Approved (Licensed)
Nov 19 · Approved in the US [10]
May 19 · RedHill Biopharma has submitted a New Drug Application to US FDA for the approval of amoxicillin/omeprazole/rifabutin for the treatment of H. pylori infections [9].
Nov 14 · FDA Grants Qualified Infectious Disease Product (QIDP) fast-track designation for RHB-105 in H.Pylori [4].

Category

Antibiotics + PPI combination product for H Pylori
The prevalence in 2008 was 30-40% in the UK adult population with pockets of higher prevalence associated with deprivation. The prevalence has in fact decreased considerably over the period of a decade. [1]
Helicobacter pylori bacterial infection - first-line
Oral

Trial or other data

May 20 · PIII ERADICATE Hp2 study (NCT03198507, n=455) is published; it found a superior eradication rate with a combination of rifabutin, amoxicillin and omeprazole vs amoxicillin and omeprazole (83.8% vs 57.7%, p<0.001). Diarrhoea was more common with the rifabutin combination regimen (10.1% vs 7.9%) [11].
Dec 18 · Broader spectrum of activity than current regimens as cited by manufacturer [5].
Jun 15 · Top-line results from the RHB-105 PIII study was designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori infection. A total of 118 dyspepsia pts with confirmed H. pylori infection were enrolled and treated in the ERADICATE Hp study. Pts were randomised in a 2:1 ratio to receive either RHB-105 or a placebo for 14 days, and assessed for the eradication of H. pylori infection 28 to 35 days after completion of treatment. RHB-105 demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. The study successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70% (p<0.001). No serious adverse events or unexpected safety issues were identified. Full results from the RHB-105 PIII study are expected in the third quarter of 2015 [6].
May 15 · Dosing with RHB-105 completed in the blinded stage of the ERADICATE Hp PIII study and top-line results are expected in June 2015. The primary endpoint of the study is to show superiority in eradication of H. pylori bacterial infection over historical standard of care efficacy levels of 70% effectiveness. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA under the GAIN Act, enabling development to benefit from fast-track status [5].
Nov 14 · Top-line data from the ongoing RHB-105 first Phase III study in the US are now expected in the second quarter of 2015 [4].
Dec 13 · The first pts have been dosed in the ERADICATE Hp study. PIII data is expected by the third quarter of 2014. [3]
Nov 13 · Pt screening process initiated in the ERADICATE Hp study - a PIII clinical study in the U.S. designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection. [2]
Topline data from ERADICATE Hp2 study (NCT03198507, n=455) successfully met its primary endpoint of H. pylori eradication (84% vs. 58%, p<0.0001). ERADICATE Hp2 is a 2-arm, randomised, double-blind, active comparator-controlled, confirmatory study in pts with dyspepsia—or indigestion and H. pylori infection. Pts received either 4 capsules TDS for 14 days of either RHB-105 or a combination of amoxicillin and omeprazole. No safety issues were reported in the study and TALICIA® was found to be well tolerated.[7,8]