RedHill Biopharma Ltd. (NASDAQ: RDHL) drew strong investor interest in the previous trading session following a significant regulatory update. That resulted in a 26.34% rise in RDHL stock price causing it to close the session at $2.35.
FDA Supports First-Ever MAP-Positive CD Trial
RedHill announced encouraging feedback from the U.S. Food and Drug Administration (FDA) regarding its RHB-204 development program for Crohn’s disease (CD). During a planned Type C meeting, the FDA gave RedHill guidance that outlined a clear regulatory path for the RHB-204 Phase 2 study.
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The intended experiment will be the first in the history of Crohn’s disease to concentrate on a particular patient subgroup: those with Mycobacterium avium subspecies paratuberculosis (MAP-positive). This innovative method looks into MAP as a possible underlying cause of Crohn’s disease, establishing RHB-204 as a ground-breaking treatment that targets the illness’s causes as well as its symptoms.
Cutting-Edge Diagnostics and Novel Study Design
One of the primary obstacles in prior MAP-targeted therapies has been the ability to detect the slow-growing bacteria reliably. To address this, RedHill is collaborating with two prominent academic institutions to utilize advanced MAP detection technologies.
These diagnostic tools will support a robust study design and may have future commercial applicability. The upcoming Phase 2 trial will measure primary endpoints such as mucosal remission—now considered the FDA’s new gold standard in CD treatment—correlated with MAP status and clinical remission.
These markers are reinforced by strong safety and efficacy data from RedHill’s prior RHB-104 Phase 3 study. Additionally, the innovative use of imaging and MAP diagnostics could reduce sample size requirements, lowering costs and accelerating timelines.
Oral Therapy Could Redefine CD Treatment
RHB-204 has demonstrated safety and compatibility with existing treatments, including anti-TNFs, immunomodulators, and steroids. With up to 40% of CD patients failing current anti-TNF options and many therapies involving high costs and intravenous administration, RHB-204’s potential as a safe, effective, oral alternative is significant.
RedHill is pursuing non-dilutive funding avenues and partnership opportunities to support the advancement of this potentially transformative therapy.
