Codexis Announces Results of Phase 1a Clinical Trial with CDX-6114
CDX-6114 meets safety and tolerability endpoints
The randomized, double-blind, placebo-controlled Phase 1a study evaluated the safety and tolerability of CDX-6114 in 32 healthy volunteers evenly divided into four cohorts. Each cohort was administered a single dose of CDX-6114 at increasingly higher dose levels. CDX-6114 was well tolerated at all four dose levels with no serious adverse events (SAEs) or GI-related symptoms observed. In addition, a dose-dependent pharmacodynamic response was observed, and an initial readout on pharmacokinetics was obtained with no evidence of systemic exposure.
“We have reached a key milestone for the company with the completion of our first ever clinical study on a novel biotherapeutic candidate developed using our CodeEvolver® protein engineering platform,” said
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.
To the extent that statements contained in this press release are not descriptions of historical facts regarding
LHA Investor Relations
Source: Codexis, Inc.