Codexis Doses First Subjects in Phase 1a Trial of CDX-6114
This randomized, double-blind, placebo-controlled Phase 1a trial is intended to evaluate the safety and tolerability of CDX-6114 in up to 32 healthy volunteers, with up to four cohorts receiving a single dose of CDX-6114 at increasingly higher dose levels.
“Initiation of this clinical trial is a major milestone in the development of CDX-6114 for the management of the orphan metabolic disorder PKU. CDX-6114 is the first biotherapeutic discovered using our CodeEvolver® protein engineering platform to enter human studies,” said
“PKU is caused by the deficiency or absence of the natural enzyme for the metabolism of phenylalanine, and can lead to intellectual disability, seizures and cognitive and behavioral disabilities,” he added. “Physicians have been able to test for PKU for more than 50 years, yet treatment options have been limited primarily to dietary management. CDX-6114 is an orally dosed, GI-stable therapeutic enzyme developed to compensate for the missing natural enzyme.”
About Phenylketonuria (PKU)
PKU is an inborn metabolic disorder resulting from a mutation in the gene for the enzyme that converts the essential amino acid phenylalanine, present in almost all dietary protein, into tyrosine. As a result of this deficiency, phenylalanine builds up to levels that are toxic in the brain, causing serious neurological symptoms including intellectual disability, seizures and cognitive and behavioral disabilities. To avoid phenylalanine toxicity and the most severe disease symptoms, individuals with PKU must follow a strict, life-long diet that is low in phenylalanine and supplement their diet with a synthetic phenylalanine-free formula to provide sufficient nutrients. Maintaining a strict, life-long diet is a challenge for individuals with PKU. There are an estimated 50,000 people with PKU in the developed world.
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Source: Codexis, Inc.