10 Dec H.pylori: Triple Therapy Pill TALICIA® Has Potential To Become Best Treatment Option

MedicalResearch.com Interview with:

MedicalResearch.com: What is the background for this announcement? Would you briefly explain the significance of H. pylori infections?  What are the potential complications of infection with this bacteria?

Response: Heliobacter pylori is one of the most prevalent human pathogens. H. pylori bacterial infection affects over 50% of the adult population worldwide¹ and 30-40% of the U.S. population², with an estimated 2.5 million patients treated annually in the U.S.³ People infected with H. pylori may suffer from gastritis and have an increased risk of developing ulcers and gastric cancers. In fact, H. pylori is classified as a group I carcinogen by the International Agency for Research on Cancer in part because it is the strongest risk factor for the development of gastric cancer.⁴

Eradication of H. pylori is becoming more difficult. Current standard-of-care therapies fail in approximately 30-40% of patients, who remain H. pylori positive. This is due to increasing resistance of H. pylori to antibiotics commonly used in standard combination therapies⁵. Clarithromycin-resistant H. pylori was formally categorized by the World Health Organization as a pathogen for which there is a high priority need to develop new treatments.⁶

The pervasive nature of H. pylori, the great health risks that it poses and the rapid development of resistance to currently available therapies speak to the great unmet medical need for new treatments that are effective at eradicating H. pylori infections. We set out to develop TALICIA®(RHB-105) as an answer to this growing public health concern with the hopes that it could someday be adopted as a new first-line therapy for all people affected by H. pylori infection.

MedicalResearch.com: How does Talicia differ from available treatments for this infection? What are the main findings of the Phase 3 study?

Response:  TALICIA® is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole. Current standard-of-care therapies consist of combinations (triple therapy or quadruple therapy) including either one or both of the antibiotics clarithromycin and/or metronidazole. The antibiotic rifabutin is unique to TALICIA® and is not a part of other standard-of-care treatments for H. pylori infection.

The Phase 3 study with TALICIA® for H.pylori eradication (the ERADICATE Hp2 study) successfully met itsprimary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with TALICIA® versus58% in the active comparator arm in the intent-to-treat population(p<0.0001). No safety issues were reported in the study and TALICIA® wasfound to be well tolerated.

Additional findings from this study contribute to our evolving understanding of the current state of H.pylori antibiotic resistance. Preliminary H. pylori culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S.states confirmed the high resistance of H. pylori to the antibiotics most commonly used for treatment, clarithromycin (17%resistance) and metronidazole (43% resistance). Importantly, no resistance torifabutin, a key component in TALICIA’s unique and proprietary formulation, was detected in the study. Moreover, consistent with the literature describing the diminished efficacy of standard-of-care therapies, preliminary results⁷ from the open-label part of the ERADICATE Hp2 Phase 3 study showed 64% eradication of H. pylori with these therapies.

Existing approved therapies can be categorized into two main groups: triple therapy (e.g. Prevpac and Omeclamox) and quadruple therapy (Pylera). SOC triple therapy has been by far the most commonly prescribed therapy. Its efficacy has diminished to approx. 60% eradication. Efficacy of quadruple therapy has also been decreasing over time(80% per Toronto Consensus Report. Moreover, Quadruple therapy is a more onerous regimen than triple therapy –  it needs to be taken 4 times a day and has a less attractive side-effect profile. Given its overall characteristics quadruple therapy is not widely prescribed for first-line therapy, despite being approved for over 12 years in the U.S.

In summary, TALICIA® is a novel triple therapy and has the potential of being positioned as a best-in-class therapy for H. pylori:

• Demonstrated 89% and 84% eradication success in two current randomized controlled studies
• Minimal resistance to TALICIA® antibiotics
• Shows an excellent safety profile
• An all-in-one capsule formulation allows for physician and patient preference due to enhanced patient convenience and compliance, all with a single co-pay

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: We are all thrilled with the study results which support the outstanding efficacy of TALICIA® for treating H. pylori infections. The excellent results could position TALICIA® to become the new standard-of-care, best-in-class, first-line therapy for eradication of H. pylori. Our immediate next steps are to engage with the FDA about advancing TALICIA® through the New Drug Application (NDA) process towards what we hope is commercialization of this product by the end of 2019. We are diligently working to bring TALICIA® to all people in need as soon as is possible.

As far as additional research goes, it is important to continue to monitor rates of antibiotic resistance. Medical professionals have to be kept aware as current standard-of-care treatments for H. pylori infections become less effective. This will allow them to choose the best therapeutic option for their patients.

MedicalResearch.com: Is there anything else you would like to add?

Response: I would like to thank all the patients, physicians and clinical staff who were involved in this study, as well as the lead investigator of the study, Professor DavidGraham, and the RedHill team for their commitment to benefiting patients infected with H. pylori.

Looking forward, 2019 will be a year filled with potential transformative milestones for RedHill Biopharma. In addition to working towards approval and launch of TALICIA® in the U.S., we plan to initiate a Pivotal Phase 3 study with RHB-204 for the treatment of nontuberculous mycobacteria(NTM) infections and continue to advance our other Phase 3 gastrointestinal programs towards potential approval.

References:

1. Kakelar HM et al. Pathogenicity of Helicobacter pylori in cancer development and impacts of vaccination. Gastric Cancer 2018:1-14.
2. Chey WD et al. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol 2007;102:1808–1825.
3. Foster Rosenblatt market analysis, October 2018.
4. 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.
5. Savoldi A et al. Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World Health Organization regions. Gastroenterology 2018;155:1372-1382; Malfertheiner, P., et al. Management of Helicobacter pylori infection—the Maastricht V/Florence consensus report. Gut 2017;66.1:6-30.
6. http://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed.
7. N=82; Not all patients in the open-label part have completed last visit; therapy in open-label part was determined by the treating physician.

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Last Updated on December 10, 2018 by Marie Benz MD FAAD