Case Study: RedHill Biopharma accelerates Phase 3 readiness for RHB-204 with Certara translational pharmacology consulting

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

RedHill Biopharma, a specialty biopharmaceutical company, sought to streamline the development of its combination antibiotic therapy, RHB-204, for a rare lung disease. The challenge was the lack of an existing non-clinical model to evaluate the efficacy of its unique three-drug combination, which was a critical step in preparing for Phase 3 trials. They engaged Certara for its translational pharmacology consulting services to address this gap.

Certara scientists implemented an integrative translational framework, employing multiple modeling and simulation techniques. This included designing and interpreting an in vitro hollow fiber study, a translational mouse model, and an in vitro biofilm model to demonstrate the combination's efficacy. Certara's pharmacokinetic modeling and integrated analysis supported the design of the Phase 3 dosing regimen and were instrumental in gaining FDA acceptance of the trial protocol. This work significantly reduced the development time needed to advance RHB-204 into its ongoing Phase 3 study and was key to securing a new patent for the combination therapy.

RedHill Biopharma