Benzinga | May 21, 2021 12:18PM EDT

RedHill Biopharma Presents A New Travelers' Diarrhea Clinical Severity Classification Tool And Its Use In Aemcolo Efficacy Analysis At DDW 2021

RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation (poster number: Fr244) at Digestive Disease Week 2021 of a new Travelers' Diarrhea (TD) severity classification tool providing clear separation of clinical severity categories and prognostic information for TD resolution, with potential utility in clinical practice. The new tool was developed with the Center for Infectious Diseases, University of Texas Houston School of Public Health.

The new classification tool was used to assess the efficacy of Aemcolo(r) (rifamycin) for the treatment of TD caused by non-invasive strains of E. coli in adults[1], reconfirming high levels of efficacy across both moderate and severe patient groups.

"Antibiotics are the mainstay of treating bacterial TD; due to growing resistance, they should be reserved for use in more severe cases of the disease," said Professor Herbert L. DuPont, Director of the Center for Infectious Diseases, University of Texas Houston School of Public Health. "In order to help direct treatment to the most appropriate patients, we developed a new severity classification tool able to support accurate prognosis of disease course and resolution, based on extensive patient data from two Phase 3 trials in Travelers' Diarrhea, providing significant potential clinical utility. We then used the new classifications to assess the efficacy of rifamycin, reconfirming highly statistically significant efficacy across both newly reclassified moderate and severe patient groups."

"Outcomes-focused clinical tools to assess the prognosis in TD have been lacking, and the development of this new Travelers' Diarrhea severity classification tool provides prognostic information that may help guide clinical practice," said June Almenoff, M.D., Ph.D., FACP, RedHill's Chief Medical Officer. "As the world returns to normal post-COVID pandemic, many Americans will likely want to resume travelling to countries where they are at high risk of infection with TD and will want to avoid the risk of ruining their trip by planning ahead for potential cases of TD."

Aemcolo, containing 194 mg of rifamycin as delayed-release tablets, is an orally-administered, non-systemic antibiotic employing MMX(r) technology, a proprietary drug delivery system that distributes rifamycin in a controlled manner to the lower intestine. Due to its non-systemic delivery, Aemcolo is associated with limited side effects and minimal potential for interactions with other medications.

Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book[2]. The recommended dosage of Aemcolo is 388 mg (two tablets) orally, twice daily for three days.