CDX-6114 / Nestle, Codexis - LARVOL DELTA

Pharmacodynamics, safety, tolerability and pharmacokinetics of a single oral dose of an engineered phenylalanine ammonia-lyase in patients with phenylketonuria. (PubMed, Mol Genet Metab Rep) - "A single dose of CDX-6114 was safe and well tolerated, with no serious adverse events or presence of anti-drug antibodies detected. Efficacy will be explored in future trials using an optimised formulation."

Journal • PK/PD data • Gastrointestinal Disorder • Metabolic Disorders • Phenylketonuria • Rare Diseases

A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Codexis Inc.; Recruiting ➔ Completed

Trial completion

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Nestlé; N=36 ➔ 0; Trial completion date: Aug 2021 ➔ Dec 2021; Initiation date: Apr 2020 ➔ Dec 2020; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Metabolic Disorders • Phenylketonuria • Rare Diseases

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU) (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: Nestlé; Recruiting ➔ Completed

Clinical • Trial completion • Metabolic Disorders • Phenylketonuria • Rare Diseases

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Nestlé

Clinical • New P1 trial

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU) (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Nestlé; Trial completion date: Dec 2019 ➔ Aug 2020; Trial primary completion date: Dec 2019 ➔ Jun 2020

Trial completion date • Trial primary completion date