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The purpose of this multi-center, open-label trial is to evaluate the activity, safety, and pharmacokinetics of ataluren in approximately 24 adult male patients with nonsense mutation hemophilia A or nonsense mutation hemophilia B. The primary goal of the trial, which consists of two 14-day treatments at two different dose levels, is to determine if ataluren can safely increase FVIII and FIX activity levels.
According to PTC Therapeutics, Ataluren, an orally-administered small-molecule, is the first investigational new drug designed to restore the formation of a functioning protein in patients with genetic disorders due to a nonsense mutation.
PTC Therapeutics has an exclusive collaboration with Genzyme for the development and commercialization of ataluren. PTC Therapeutics will commercialize ataluren in the US and Canada, while Genzyme will commercialize the product in other regions of the world.
Stuart Peltz, president and CEO of PTC Therapeutics, said: "This proof-of-concept trial in a third indication represents a major step forward in the development of ataluren as a potential treatment for nonsense mutation genetic disorders. We are excited by the clinical progression of ataluren.
"We recently initiated a pivotal trial in nonsense mutation cystic fibrosis and expect to complete the pivotal trial in nonsense mutation Duchenne and Becker muscular dystrophy by the end of 2009 with results expected to be announced in the first half of 2010."
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