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

“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.

RHB-104 is a triple antibiotic formula that is used to treat MAP bacterium. MAP is a shorter way of saying “Mycobacterium avium subspecies paratuberculosis” bacterium. The inception of RHB-104 dates back to the late 1990s with development being started by Dr. Thomas Borody of the Centre for Digestive Diseases.  The three components of RHB-104 are Rifabutin, Clarithromycin and Clofazimine which are all rather common antibiotics, the difference is in using all three, dosage level & duration of treatment.

Dr. Borody has also helped in the development of different triple antibiotic treatments for H. Pylori infections, which is a leading cause of peptic ulcers. One of these treatments was also purchased by RedHill Biopharma which has labeled it RHB-105. I’ve also mentioned Dr. Borody’s work on fecal transplantation / bacteriotherapy which is another treatment Dr. Borody uses for Crohn’s Disease.

What is now known as RHB-104 in the US has been a hot potato throughout the biotech world for over the last decade. The drug formula was initially licensed to a company called Pharmacia, but upon their merger with Pfizer(who did not wish to continue development of the drug), ownership fell back to the Dr. Borody founded company Giaconda under the name “Myoconda”. Finally in August of 2010, RedHill Biopharma purchased the rights to Myoconda for US & European distribution.

RedHill Biopharma does appear to be serious about bringing RHB-104 to market what with the recent exclusive acquisition of a DNA based MAP bacterium infection test that was developed by Dr. Saleh Naser of the biomedical division at the University of Central Florida.

MAP infection appears to be present in about 40 – 50% of those with Crohn’s Disease. MAP bacterium are known to cause Johne’s disease in animals such as cattle. Johne’s disease is an inflammation of the small intestine & can be fatal in some cases. Currently there is no definitive proof that MAP infection is the cause of Crohn’s Disease, the fact alone that not all patients with Crohn’s Disease have MAP infections should highlight that MAP is probably not the sole cause for all patients. It could be the sole cause or at least a contributing factor for some though. The main link between MAP & Crohn’s Disease is from studies showing that MAP infection is more prevalent in those with Crohn’s Disease than in those who have Ulcerative Colitis.

What with concerns over antibiotics causing Crohn’s Disease, some may have worries about this treatment essentially being 3 different antibiotics. I would not be too concerned if someone has already been given a diagnosis of Crohn’s Disease as you cannot change your diagnosis & if you test positive for MAP infection perhaps MAP was more the cause of the disease than antibiotic usage. Of course some could argue that antibiotic usage might lead to more susceptibility of MAP infection. Neither theories are proven though. Perhaps a combination of RHB-104 along with Dr. Borody’s bacteriotherapy could be a likely treatment avenue for those concerned about their digestive bacterial flora’s health post-treatment.

RedHill Biopharma has not released a date for when the trials are too begin, but assigning Professor  Graham as the leader of the study appears to be a step in the right direction.