RedHill Earns Long-Awaited Boost On Positive Crohn's Data

REDHILL BIOPHAR/S ADR RDHL achieved positive top-line results in its Phase 3 study of RHB-104 in Crohn’s disease, according to a Monday press release.

What Happened

The drug met both primary and secondary endpoints by demonstrating a remission rate superior to that of the placebo and consistent benefit to patients with Crohn’s, according to RedHill. 

RedHill also reported a positive safety profile as well as statistical significance in participants experiencing early remission and sustained remission.

Why It’s Important

RedHill expects the therapy to become a leading Crohn’s treatment. The indication has a market of 1.5 million people who are expected to spend more than $10 billion on therapies in 2018.

“Many patients with Crohn's disease do not achieve remission on current standard-of-care therapies, which are accompanied with poor side effects,” David Graham, the study’s principal investigator, said in the press release. “RHB-104 appears to have the potential to become a promising, new orally administered therapy for this important debilitating disease."

What’s Next

RedHill will present data before the Food and Drug Administration to develop a path to approval and continue to discuss commercialization with potential partners. It expects additional studies will be needed to support a New Drug Application.

The stock was trading up 3.82 percent at $9.79 at the time of publication Monday morning. 

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