Codexis, Nestle Health Science announce interim CDX-7108 results

Codexis and Nestle Health Science announced interim results from a Phase 1 study to investigate the safety, tolerability, pharmacokinetics, or PK, and pharmacodynamics of CDX-7108. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of existing pancreatic enzyme replacement therapy, or PERT. PERT is the main treatment for exocrine pancreatic insufficiency, or 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 CDX-7108 Phase 1 clinical trial is a study evaluating the safety, tolerability, and pharmacokinetics of escalating oral doses of CDX-7108 in 48 healthy adult subjects and to assess the pharmacodynamics of oral doses of CDX-7108 as part of a proof-of-concept study in 10 subjects with EPI. The interim analysis included five subjects and examined lipid absorption as measured by 13CO2 excretion. No safety issues were noted with no Serious Adverse Events, or SAE, observed and no treatment discontinuations in the Single Ascending Dose, or SAD, and Multiple Ascending Dose, or MAD, healthy subject groups. Every participant with EPI in the proof-of-concept portion of the study showed improved lipid absorption when administered CDX-7108 versus placebo. Combining the data from each participant, a significant increase in the cumulative excretion rate of 13CO2 was observed for CDX-7108 versus placebo. Codexis and Nestle Health Science expect to file an investigational new drug, or IND, application for the Phase 2 study by the end of 2023. The Phase 2 study is expected to be conducted over approximately 12 months, with topline data expected in 2025.