Information on Myoconda – A MAP Treatment? |
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Currently, Crohn's disease is treated with drugs focusing on reducing inflammation and other symptoms. However, standard treatments only aim to help relieve symptoms not to treat the cause of the disease. Myoconda is a new potential drug aimed at addresses the source of the disease instead of merely trying to alleviate its symptoms. In order to address the source of the disease, Myoconda targets Mycobacterium avium paratubercluosis (MAP), which is the main candidate as an infectious cause of Crohn's disease.
Myoconda is being introduced by Giaconda Limited and is a combination of three antibiotics, rifabutin, clarithromycin and clofazimine. All three of these drugs are used to treat mycrobacterial and other infections and are widely marketed. For the first time ever, Myoconda introduces these three antibiotics in a patented combination.
Professor Borody has based his approach on the idea that Crohn's Disease is caused by infection. Gastrointestinal specialists worldwide are increasingly starting to accept that this may indeed be the case. Professor Borody's clinical trials have given significant data indicating that patients treated with Myoconda often experience long-term remission of symptoms and inflammation, some for up to five years.
In 2002, a Phase II clinical trial of Myoconda, which was performed at the CDD, was published. Pharmacia was granted an option to license the Myoconda patent in 2000 on the condition that there would be a Phase III clinical trial. An Australian Phase III clinical trial was conducted by Pharmacia. The trial, which was completed in September 2004, was being done to evaluate the efficacy of Myoconda when treating 213 Crohn's patents over three years.
On March 17, 2005, the Phase III trial results were presented in Birmingham, UK at the British Society of Gastroenterology. Professor Borody has shown that these results show a statistically large improvement in successfully achieving remission when using Myoconda when compared to conventional therapy. No significant difference was show in maintaining remission between Myoconda and conventional therapy.
In order to improve the efficacy of the treatment in achieving and maintaining remission, Giaconda will increase the dosage of clofazimine in its next Phase III trial. Since a lower dosage of clofazimine was used in the most recent Phase III trial, Pro. Borody feels strongly that increasing the dosage will help improve the efficacy of Myoconda in both achieving and maintaining remission.
The results of these trials will be used by Giaconda as the base for further clinical development. Typically, the FDA does require two successful Phase III clinical trials to be completed in accordance with the guidelines of the FDA. In result, a second study is planned for Myoconda. Currently, 54 patients are being treated at CDD in a study to add further proof of the efficacy of Myoconda. These tests results are anticipated to be available late 2005. All in all, with the first Phase III study of Myoconda under their belt, Giaconda has set forth a clearly defined path to market the product. Commerical launch in the US is expected in 2008.
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