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news.Wythe Therapeutics has acquired worldwide rights to manufacture, market and distribute VeroScience's drug candidate Cycloset, currently in development for the treatment of type-2 diabetes. Financial terms of the deal were not disclosed.
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Cycloset is believed to act within the central nervous system principally as a direct dopamine agonist to reset neural pathways controlling peripheral metabolism. Results of published clinical studies of varying designs and patient populations suggest that treatment with Cycloset may improve hyperglycemia, glucose intolerance hyperlipidemia, or aspects of insulin resistance, while maintaining body fat neutrality or inducing fat reduction.
Cycloset use for the treatment of type-2 diabetes has been studied in several phase II and three phase III studies. An new drug application for the drug's use in the treatment of type-2 diabetes has received an approvable letter setting out what remaining data are required for approval.
Among the considerations raised by FDA, the approvable letter primarily required a large, simple safety trial, which Vero is currently conducting and Wythe is funding.
The study is a randomized, double blind, placebo controlled trial in 3,000 subjects with type-2 diabetes. The study is fully enrolled and completion is expected by the end of 2006.
Vero is also conducting a clinical study to determine the effectiveness of Cycloset as add-on therapy in type-2 diabetes subjects whose blood sugar is not adequately controlled on Metformin therapy. Vero expects to file an amended Cycloset NDA (a complete response to the approvable letter) in the first half of 2007.
“We are extremely excited to work with Vero to bring this unique and important therapy to market. If approved, Cycloset will be a 'first in class' compound in the treatment of type-2 diabetes utilizing a CNS mode of action,” said Charles Sutphin, CEO of Wythe.