TEL AVIV: Israel’s RedHill Biopharma said it had positive safety and efficacy results from a late-stage clinical trial with its treatment for Crohn’s disease called RHB-104.
The study met its primary endpoint and key secondary endpoints, demonstrating the drug’s superiority over a placebo in achieving remission of the gastrointestinal disease at week 26, the company said in a statement.
“The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo,” RedHill said.
Patients treated with RHB-104 also experienced a statistically significant benefit in achieving early remission at week 16 and in durable remission over weeks 16-52.
RHB-104 was found to be generally safe and well tolerated, said the company, which is focused on proprietary drugs for gastrointestinal diseases.
“Many patients with Crohn’s disease do not achieve remission on current standard-of-care therapies, which are accompanied with poor side effects,” said David Graham, lead investigator of the Phase III study.
“RHB-104 appears to have the potential to become a promising, new, orally administered therapy for this important debilitating disease.”
RHB-104 is a proprietary, antibiotic combination therapy that is based on the hypothesis that Crohn’s disease is caused by a bacterial infection in susceptible patients called Mycobacterium avium subspecies paratuberculosis (MAP).
The Phase III study of RHB-104 enrolled 331 subjects with moderately to severely active Crohn’s disease in the United State, Canada, Europe, Australia, New Zealand and Israel.
An extension Phase III study is ongoing to evaluate RHB-104 in patients who remain with active Crohn’s disease after 26 weeks of therapy in the first Phase III trial.
Additional clinical studies will most likely be required to support filing a new drug application.
“RedHill will meet with key opinion leaders and the U.S. Food and Drug Administration to present the data package and discuss the development path to potential approval and will continue discussions with potential partners for RHB-104,” the company said.
Approximately 1.5 million people worldwide have been diagnosed with Crohn’s disease. Global sales of Crohn’s disease therapies are estimated to exceed $10 billion in 2018, RedHill said, citing data from research firm GlobalData.
($1 = 3.6622 shekels) (Reporting by Tova Cohen; editing by Jason Neely)