RedHill Biopharma Presents New Data from Talicia®’s Phase 3 Studies at ACG 2020 Focused on Achieving Successful First-Line Treatment in H. pylori Eradication
H. pylori eradication rates with clarithromycin-based triple therapy were found to be predictably low in the Phase 3 trial, with antibiotic resistance a contributing factor. Despite declining efficacy, physicians are still prescribing these regimens counter to ACG guidelines, which advocate for using first-line regimens that provide the highest likelihood of eradication success
Talicia’s efficacy in the Phase 3 study was unaffected by patient body mass index (BMI), while published data suggest that BMI may be associated with the failure of clarithromycin-based H. pylori treatments, further supporting the use of Talicia as a first-line therapy in all populations
Talicia is the first and only FDA-approved rifabutin-based therapy for the treatment of H. pylori infection, designed as a first-line option to address the high and growing resistance of H. pylori to commonly used antibiotics
A key objective of the new
Poster 1: Persistent H. pylori infection following participation in two randomized controlled trials: Outcomes of patients receiving physician-directed standard-of-care therapy4.
This analysis of data from the Talicia Phase 3 studies looked at the cure rates of physician-directed standard-of-care therapy for persistent H. pylori infection. The analysis found that eradication rates with empiric clarithromycin-based triple therapy were predictably low, and that despite declining efficacy of clarithromycin-containing therapies, physicians are still prescribing these regimens.
“Despite the ACG treatment guideline recommendations for avoiding clarithromycin-containing triple therapy in patients with prior macrolide use and as salvage treatment, as well as other recommended restrictions based on resistance, clarithromycin-based therapies unfortunately remain an all too often prescribed treatment for H. pylori,” said Dr.
Poster 2: Efficacy of H. pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by BMI: Post-hoc analysis from two Phase 3 trials5.
Winner of the ACG “Outstanding Poster Presenter” Award.
With rising rates of obesity in the
“Antibiotic treatment failure in obese populations with H. pylori is a significant concern and may be linked to elevations in BMI,” said Dr.
About Talicia (omeprazole magnesium, amoxicillin and rifabutin)
Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to commonly used clarithromycin-based therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapy and are a strong public health concern, as highlighted by the FDA and the
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%9 of the
TALICIA: INDICATION AND USAGE
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.
Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com
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 associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type 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 and commercial products; (v) the Company’s ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
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1 Omeprazole magnesium, amoxicillin and rifabutin delayed release capsules. Also referred to as RHB-105
3 Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in
4 Persistent H. pylori infection following participation in two randomized controlled trials: Outcomes of patients receiving physician-directed standard-of-care therapy.
5 Efficacy of H. pylori eradication by low-dose rifabutin triple therapy (rhb-105) is unaffected by BMI: Post-hoc analysis from two Phase 3 trials.
6 Cerqueira, R. M., Correia, M. R., Fernandes, C. D., et al. (2013). Cumulative Helicobacter pylori eradication therapy in obese patients undergoing gastric bypass surgery. Obes Surg, 23(2), 145-149. doi:10.1007/s11695-012-0747-4.
7 Defined as the PK population which included those subjects in the ITT population
8 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
9 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
10 IQVIA Custom Study for
11 Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
13 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
15 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O’Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
16 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
17 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
18 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
Source: RedHill Biopharma Ltd.