RedHill Biopharma expects top-line clinical trial results on two drugs by the end of the year


RALEIGH – RedHill Biopharma, based in Raleigh and Tel-Aviv, Israel, a specialty biopharmaceutical company primarily focused on lateclinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases, has enrolled over 300 of  the planned extotal of 444 patients, in the ongoing confirmatory Phase III study investigating Talicia.

RedHill remains on track to potentially complete enrollment of the ERADICATE Hp2 study in the third quarter of 2018 and expects to announce top-line results in the fourth quarter of 2018. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma and is estimated to affect over half of the adult population worldwide.

The 2015 worldwide and U.S. markets for H. pylori eradication therapies were estimated at approximately $4.83 billion.

The company opened offices in Raleigh in early 2017 as a base for its U.S. commercial operations. It has 20 people in its Raleigh office, 40 field sales agents throughout the country, and another 20 employees in Raleigh.

The company reported revenues of $2 million in the fourth quarter, 2017, a 31 percent boost from the previous quarter.

It also reported this week that it expects top-line results of its Phase III study of its RHB-104 treatment for Crohn’s disease in about three months.

Approximately 1.5 million people were diagnosed with Crohn’s disease worldwide in 20174. Worldwide sales of Crohn’s disease therapies are estimated to exceed $10 billion in 2018.

 

RHB-104 is a potentially ground-breaking, proprietary, orally-administered antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.

Additional clinical studies are likely to be required to support a U.S. New Drug Application (NDA) for RHB-104, if filed. If the MAP US study results are positive, RedHill will meet with key opinion leaders and the U.S. Food and Drug Administration (FDA) to present the data package and discuss the preferred path to potential approval.

(NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) stock

 



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