RedHill’s RHB-204 Matches MAP Killing of RHB-104 with Lower Doses
RHB-204 demonstrated comparable MAP killing efficacy to RHB-104 in spot and phage assays while using lower doses of two active ingredients, suggesting reduced toxicity. A Phase 2 trial in defined MAP-positive Crohn’s disease patients is planned with non-dilutive funding and potential orphan, Fast Track and QIDP designations.
1. In Vitro Killing Efficacy
New in vitro data from spot and phage assays showed RHB-204 achieves comparable MAP killing to RHB-104, using lower doses of clarithromycin and rifabutin—indicating potential for reduced toxicity and improved tolerability in Crohn’s disease patients.
2. Phase 2 Study Design
RedHill plans a randomized, controlled Phase 2 trial targeting MAP-positive Crohn’s disease patients, marking the first study in a specifically defined MAP-positive cohort with non-dilutive funding and potential orphan and Fast Track designations.
3. Regulatory and Market Potential
RHB-204 holds patent protection through 2041, with FDA Fast Track, Orphan Drug and QIDP designations extending exclusivity up to 12 years; the Crohn’s disease market is projected to grow from $13.6 billion in 2024 to $19.1 billion by 2033.