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Myoconda® – A Combination Antibiotic Therapy for the Treatment of Crohn’s Disease
Crohn’s Disease
Crohn’s Disease is a chronic inflammatory disease of the gastrointestinal tract. The disease most commonly affects the lower small intestine and the large intestine. Symptoms of Crohn’s Disease include abdominal pain, diarrhoea, fever and weight loss. In severe cases, the intestine can become blocked or obstructed, requiring surgery. Young patients with Crohn’s Disease may also suffer growth retardation. Patients suffering Crohn’s Disease are conventionally treated with drugs aimed at reducing inflammation and other associated symptoms. The cause of Crohn’s Disease is unknown, thus the standard treatments aim to treat symptoms rather than the cause of the disease. The bacterium Mycobacterium avium paratuberculosis (MAP) is the lead candidate as an infectious cause of Crohn’s Disease. By targeting the MAP infection, Myoconda® is designed to address the possible source of the disease, rather than attempting to merely alleviate its symptoms.
Myoconda®
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.
Pharmacia, who had taken an option for the license to Myoconda® from CDD in 2000, conducted a Phase IIIa clinical trial involving 213 patients. The trial was completed in September 2004. Overall results of the Phase IIIa trial demonstrated a statistically significant improvement in achieving remission at 16 weeks when using Myoconda® compared with conventional therapy. However, Myoconda® did not achieve statistically significant results in maintaining remission after therapy was complete in this trial.
When Pharmacia and Pfizer merged, the rights to Myoconda® were returned to CDD and then the intellectual property was sold to Giaconda. On the basis of these trial results Giaconda decided that a revised drug development program should be pursued. The dosage of clofazimine used in Pharmacia’s Phase IIIa trial was lower than that used in previously published studies. In the next trial Giaconda will increase the dosage anticipating that this will improve the efficacy of Myoconda® in achieving and maintaining disease remission.
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