Codexis, Inc. (NASDAQ: CDXS), a leading protein engineering company and developer of novel biotherapeutics, and Nestlé Health Science, a globally recognized leader in the field of nutritional science, announced today the dosing of the first subject in a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108.
CDX-7108 is a lipase variant specifically engineered to overcome the limitations of traditional pancreatic enzyme replacement therapy (PERT) deficiencies. PERT is the main treatment for exocrine pancreatic insufficiency (EPI), a debilitating condition of the GI-tract that is caused by conditions that impair pancreatic function, such as pancreatitis, pancreatic cancer, Crohn’s disease, celiac disease, and cystic fibrosis. CDX-7108 was engineered to be highly stable to the acidic conditions in the stomach and resistant to proteases in the upper intestines.
The integrated, three-part Phase 1a/1b study comprises a randomized, double-blind, placebo-controlled dose escalation to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single (part A) and multiple (part B) oral dose administration in healthy adult subjects. Part C is a randomized, double-blind, placebo-controlled, single-dose, 2-way crossover study to assess proof-of-concept of CDX-7108 for pharmacodynamics, safety, tolerability, and immunogenicity in subjects with EPI.
“Our partnership with Nestlé Health Science aims at leveraging the CodeEvolver® protein engineering platform to create novel orally administered enzyme therapies for patients. We are excited to advance the first candidate from this partnership, CDX-7108, into clinical development”, according to John Nicols, Codexis’ President and CEO. “The complementarity of Nestlé Health Science’s gastrointestinal experience and Codexis’ proven ability to discover and develop differentiated enzymes, has led to the rapid advancement of CDX-7108 into the clinic”, Gjalt Huisman, Senior Vice-President, Codexis Biotherapeutics added.
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