Myoconda®, the Company’s therapy for the treatment of Crohn’s Disease is a combination of three registered antibiotics - rifabutin, clarithromycin and clofazimine. These three drugs are widely marketed world-wide for the treatment of mycobacterial and other infections. Myoconda® presents these three compounds in a specific patented combination.
Myoconda® is based on the proposition that Crohn’s Disease is caused by infection. Prof. Borody has long been at the forefront of this approach, which is gaining increasing acceptance among gastrointestinal specialists worldwide. Prof. Borody has published significant data demonstrating that patients treated with Myoconda®’s antibiotic combination experience long-term remission of clinical symptoms and inflammation, some for up to nine years.The results of a Phase II clinical trial of Myoconda®, conducted at the Centre for Digestive Diseases (CDD), were published in 2002. This was followed up with a full retrospective analysis of all CDD Crohn’s patients treated for at least six months with anti-MAP therapy. This analysis of 52 patients demonstrated a remission rate of 65% with a clinical response of almost 95%. These results exceed those of any Crohn’s therapy on the market by major margins.
Myoconda's Investigational New Drug (IND) application was approved by the US FDA in April 2007, allowing it to proceed with Phase 2/3 trials of the drug. It doesn't quite seem to be the silver bullet yet, but certainly is a very promising start.