|Thursday, 26 April 2007Nick Evans|
GIACONDA announced on Tuesday that the US Food and Drug Administration has approved the company's Investigational New Drug (IND) application for the clinical development of Myoconda to treat patients with Crohn's disease infected with Mycobacterium avium spp paratuberculosis (MAP).
The IND approval allows the company to begin the next clinical trial of Myoconda in the US, a multi-centre, double-blind, placebo-controlled Phase 2/3 trial currently in preparation by the company. Giaconda anticipates that the trial will commence by the end of 2007.
Myoconda has already been through a Phase 3 trial, prior to Giaconda acquiring the product. Giaconda said since acquiring the rights it has undertaken an alternative development program and reached a new understanding of the mechanism of action of Myoconda.
Giaconda said the new Phase 2/3 trial is necessary due to the changes in the drug format – it will now be an all-in-one oral capsule with increased dosages and a new indication has been sought. This has resulted in a new IND being submitted based on the new research.
The company said it believes that Myoconda is the first drug to be submitted to the FDA for this indication. There are no anti-MAP therapies approved for use in Crohn's disease.
MAP is considered as the most likely infectious cause of Crohn's disease. Current treatments on the market are indicated for symptomatic treatment of the disease. Giaconda said it believes that by treating and controlling the underlying MAP infection, Myoconda will offer a valuable therapy to patients who do not respond to currently available treatments. Current research indicates that 40–50% of Crohn's patients are MAP positive.
Giaconda chief executive Patrick McClean said that the development of Myoconda is supported by a significant number of opinion leaders in the field.
"We are very pleased to have reached this key milestone in the development of Myoconda. There is clearly a need for this type of therapy for the substantial subset of Crohn's disease patients infected with MAP who are not well served by current therapies," he said.
"Giaconda is now another step closer to achieving its aim of bringing this product to market as soon as possible for the benefit of patients who are infected with MAP."
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