RedHill BioPharma has positive results from Crohn's disease trial
30/07/2018 12:00
TEL AVIV, July 30 (Reuters) - Israel's RedHill Biopharma
RDHL.TA said on Monday 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 RDHL.O 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)
((tova.cohen@thomsonreuters.com; +972-9-899-0222; Reuters
Messaging: tova.cohen.thomsonreuters.com@reuters.net))