RedHill Biopharma is looking to start FDA & European drug trials soon for their RHB-104 MAP bacterium treatment for those with Crohn’s Disease.
The Phase II/III FDA drug trials in the US will be lead by Professor David Y. Graham from Baylor College of Medicine located in Houston, Texas. Professor Graham worked for NASA as a physician during the Apollo program, has written over 800 medical articles & is considered to be one of the “Top 50 Most Influential Gastroenterology Professionals of the 20th Century” as rated by Gastroenterology.com.
“Phase II/III” trials differ from more typical separate Phase II & Phase III trials in that the study is more randomized than a typical Phase II trial, as well as there being more participants involved. This allows data from a Phase II/III trial to be used going forward in a Phase III trial. However, Phase II/III trials require more infrastructure & patients, raising costs. Phase II/III trials could be looked at as though they are Phase III trials with stronger stop parameters than a typical Phrase III trial. Given that the drugs used within RHB-104 have gone through Phase III trials in Australia, this is probably why RedHill Biopharma is confident in moving forward with the Phase II/III style of trial. Continue reading “RedHill Biopharma’s RHB-104 MAP Treatment for Crohn’s Disease” »