RedHill Biopharma Ltd. said on Monday that a late stage clinical trial of its drug to treat Crohn’s disease found the medication to have positive safety and efficacy results.
The biopharmaceutical firm said that the results “demonstrated superiority of RHB-104 over a placebo in achieving remission at week 26,” the company said in a statement.
The company has developed RB-104 to treat Crohn’s, a severe inflammatory affliction of the gastrointestinal tract that has no known cure.
The potentially groundbreaking orally administered drug combines three kinds of antibiotics, and is based on the hypothesis that Crohn’s disease is caused by a bacterial infection called the mycobacterium avium subspecies paratuberculosis (MAP) bacteria, which has been found in patients suffering from Crohn’s.
“The robust results of this study demonstrate that RHB-104 could become a leading therapeutic option in Crohn’s disease and bring hope to patients worldwide,” said Ira Kalfus, RedHill’s medical director, in the statement. “The availability of antibiotic therapy for treating Crohn’s disease could be transformative.”
Patients treated with the drug also showed a statistically significant benefit in reaching early remission at week 16, and durable remission in weeks 16-52, the statement said.
“RHB-104 appeared to be safe and well tolerated in the study,” Kalfus said. “We continue to analyze the study data and plan to meet with key opinion leaders and the FDA to present the data package and discuss the development path to potential approval of RHB-104.”
Professor David Graham, the lead investigator of the RHB-104 MAP US study, said that the results of the trial “indicate that RHB-104 could lead to a paradigm shift in the treatment of Crohn’s disease, a chronic and debilitating and currently incurable condition with a strong unmet medical need.”
“Many patients with Crohn’s disease do not achieve remission on current standard-of-care therapies, which are accompanied with poor side effects. RHB-104 appears to have the potential to become a promising, new, orally-administered therapy for this important debilitating disease.”
The Phase III enrolled 331 subjects with moderately to severely active Crohn’s disease in the United States, Canada, Europe, Australia, New Zealand and Israel, the statement said.
Additional clinical studies are most likely to be needed to support a US New Drug Application for RHB-104, if filed, the company said.
As of 2017, some 1.5 million people worldwide had been diagnosed with Crohn’s disease, and global sales therapies for this affliction are estimated to exceed $10 billion in 2018, the statement said, citing data from GlobalData.
RedHill was founded by Dror Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and now entrepreneurs.