Helicobacter pylori infection no longer scary RedHill new drug Talicia to help

Recently, RedHill Biopharma's new drug Talicia was approved by the FDA to treat adult patients infected with Helicobacter pylori infection, which means that patients with Helicobacter pylori infection will be given a new option and make up for resistance to antibiotics commonly used in standard care therapies in patients with Helicobacter pylori infectionat present, Helicobacter pylori has been positioned by the World Health Organization (WHO) as a type of tumor-causing factor, research shows that Helicobacter pylori infection will activate the body's primary cancer gene, leading to cancer-suppressing gene inactivation, so that the body cancer gene expression abnormal, resulting in an increased risk of stomach cancerSurvey data show that helicobacter pylori has a global infection rate of about 50 per cent, and its standard treatment is triple or quadtherapy, as detailed in the table belowHowever, over time, the reduction rate of Helicobacter pylori has become more and more serious, even if remedial treatment is still some patients eradication treatment failure, and even triple and quadtherapy is difficult to ensure the complete eradication of Helicobacter pyloriTalicia is a new type of fixed-dose three-in-one oral capsule that combines two antibiotics, rifabutin (rifabutin, 12.5 mg) and amoxicillin (250 mg) and omeprazole (10 mg)Among them, lifubutin is a lificin derivative, through the dna-dependent DNA-dependent RNA polyenzyme beta sub-trot stoication of microorganisms to form a stable binding, inhibit the enzyme activity, thereby inhibiting the synthesis of bacterial RNA, with broad-spectrum antibacterial activity, research shows that lifubutin can treat the treatment of refractory Helicobacter raxella infection, the relevant content sprite in January 2012Amoxicillin is a semi-synthetic penicillin-type broad-spectrum beta-lactam antibiotic, commonly used in helicobacter pylori standard therapyOmeprazole belongs to proton pump inhibitors, can activate Helicobacter pylori, make it active, easy to be killed by antibiotics, and can regulate the stomach acid-base pH value, improve the antibacterial activity of antibioticsprior to, Talicia had been awarded qiDP qualifications by the FDA, priority review qualifications, and fast-track eligibilityRedHill announced in July that the FDA had accepted talician's application for a new drug for Hcoli infection (NDA), which is expected to be approved by November 2, 2019Although Talicia was delayed by a few days to get FDA approval, it is still worth celebrating from a wide range of patientsTalicia's approval was based on the results of a positive top line for a phase 3 trial called MI2The study, a 2-arm, randomized, double-blind, active drug control Phase III study, was conducted in 55 medical centers in the United States, including a total of 455 patients with indigestionIn the study, patients were randomly assigned to receive Talicial (4 capsules, 3 times a day) or active control drugs (Amoxerin 250mg plus omeprazole 10mg, 4 capsules, 3 times a day) for 14 consecutive daysThe final results showed that 84% of patients in the Talicia treatment group had rooted H pylori, compared with 58% in the control group, and the data were highly statistically significant, reaching the main endpoint of the study Resistance to lifubutin, a key ingredient in Talicia's unique formula, was not detected in the study and no safety issues were reported Currently, Helicobacter pylori patients are highly resistant to antibiotics commonly used in standard care therapy (mainly klinmycin and mitane, " and studies have shown that standard therapy has a 64% rate of Helicobacter pylori eradication, as evidenced by the preliminary results of the OPEN label section of the ERADICATION of THE ERADICATE H2 study Talicia's approval will undoubtedly offer new hope to patients resistant to common antibiotics from Helicobacter pylori, and RedHill's established U.S commercial operations team and sales force focused on gastrointestinal diseases are well prepared for Talicia's commercialization, which is expected to bring Talicia to the U.S market in the first quarter of 2020 References: .