On July 28, 2021 Citryll reported that first in class antibody drug candidate CIT-013 for autoimmune and chronic inflammatory diseases is beginning its bioanalytical phase at Ardena, a specialist pharmaceutical contract development and manufacturing organisation (CDMO) (Press release, Citryll, JUL 28, 2021, View Source [SID1234585444]).
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In partnership with its client Citryll, based in Oss in the Netherlands, Ardena is preparing to support the clinical phase of development of a first in class therapeutic human antibody targeting Neutrophil Extracellular Traps (NET) formation and clearance. The first-in-human study will be a randomised, double blind, placebo controlled, single ascending dose study for Citryll’s lead candidate CIT-013.
"We are very pleased to be partnering with Ardena as part of Citryll’s development programme for CIT-013," said Helmuth van Es, CEO of Citryll. "We are entering new territory. CIT-013 has the potential to impact many diseases where NET biology is contributing to the pathology, such as lupus, rheumatoid arthritis, vasculitis, sepsis, a range of serious lung inflammatory conditions and the list is still growing. Ardena has the bioanalytical skills and knowledge needed to help us develop CIT-013 and take it to the next level," he explained.
"To be involved in such an innovative drug development programme is very exciting for us," said Melloney Dröge, Business Unit Director at Ardena Assen, The Netherlands. "CIT-013 targets and inhibits the source of auto-antigens and NET derived pro-inflammatory molecules instead of the traditional approach of broadly targeting acquired immunity or inflammation," she explained. "Inhibition of NET formation and promoting their systemic clearance could change the way autoimmune, chronic inflammatory diseases and inflammatory conditions in general are treated."
Ardena will be drawing on its extensive expertise, providing full bioanalytical support from the development of PK, immunogenicity, PD and safety assays, right up to the validation of the methods and subsequent bioanalytical clinical sample analysis. The study will be conducted in healthy volunteers both with and without an intravenous lipopolysaccharide challenge.