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Codexis and Nestlé Health Science Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency
Interim Data from Phase 1 Proof-of-Concept Arm Indicates CDX-7108 Improves Lipid Absorption REDWOOD CITY, Calif., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Codexis,
About this update from Codexis, Inc.
[{"type":"text","content":"Interim Data from Phase 1 Proof-of-Concept Arm Indicates CDX-7108 Improves Lipid Absorption\nREDWOOD CITY, Calif., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, and Nestlé Health Science, a leader in the science of nutrition, today announced interim results from 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 existing pancreatic enzyme replacement therapy (PERT). 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. “We are excited by the early clinical data for CDX-7108, the most advanced candidate from our partnership with Nestlé Health Science,” said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Codexis. “Preliminary data from an interim analysis of our Phase 1 study proof-of-concept arm has shown indication of improved lipid absorption when patients were administered CDX-7108 versus placebo. Importantly, no safety issues were noted in the 48 subjects who participated in the single ascending dose and multiple ascending dose portion of the study. These encouraging data support a path forward further developing CDX-7108 with Nestlé Health Science. We aim for the potential initiation of a Phase 2 study in early 2024.” “Patients who suffer from exocrine pancreatic insufficiency are in need of new treatment options,” said Dr. Hans-Juergen Woerle, Chief Scientific and Medical Officer of Nestlé Health Science. “This interim Phase 1 data suggests that CDX-7108 could be that potential new option and we are excited to move forward to a Phase 2 clinical trial. We are pleased with this positive update and are proud to be driving the development of a novel approach for this condition as part of our strategic collaboration with Codexis.” Results of Interim Analysis The CDX-7108 Phase 1 clinical trial is a study evaluating the safety, tolerability, and pharmacokinetics (PK)...