CDXS - Codexis and Nestlé Health initiate phase 1 CDX-7108 trial

Codexis (NASDAQ:CDXS) and Nestlé Health Science announce the dosing of the first subject in a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108 for exocrine pancreatic insufficiency. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of traditional pancreatic enzyme replacement therapy (PERT) deficiencies. 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.

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Codexis and Nestlé Health initiate phase 1 CDX-7108 trial