Two labs report in vitro MAP-killing results for RHB-204
RedHill reported that two sets of in vitro studies confirmed RHB-204's capability to kill Mycobacterium avium subspecies paratuberculosis (MAP) and showed MAP-killing comparable to RHB-104 in long-term intracellular culture and spot and phage assays. The company described RHB-204, a fixed-dose oral formulation of clarithromycin, rifabutin and clofazimine, as Phase 2-ready and said it is pursuing partnerships, collaborations and innovation development grant applications. The release cited RHB-104's prior Phase 3...
Key takeaways
RHB-204 data: Two microbiology centers reported MAP-killing capability and comparability to RHB-104 across long-term intracellular culture, spot and phage assays.
Strain coverage: Positive results were seen across multiple MAP strains from human Crohn's disease patients and animal carriers of Johne's disease.
Dose profile: The company said MAP-killing efficacy in spot and phage assays was achieved with lower doses of two active ingredients than RHB-104, which it described as indicative of potential reduced toxicity and side effects.
Formulation: RHB-204 contains clarithromycin, rifabutin and clofazimine and is described as having a 40% pill burden reduction with potential for enhanced tolerability, safety and compliance.
Development status: RedHill described RHB-204 as Phase 2-ready, but the release did not provide a study start date or clinical-trial schedule.
Regulatory and intellectual property: RHB-204 is patent protected through 2041 and has FDA Fast Track, Orphan Drug and QIDP designations and an EU Orphan designation.
Partnering: RedHill said it is actively pursuing partnerships and collaborations for RHB-204, including innovation development grant applications.
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