Switzerland-based NovImmune has begun dosing in a Phase I trial of a monoclonal antibody drug candidate NI-0101, with healthy volunteers.
The first-in-human study will evaluate the pharmacokinetic, pharmacodynamic, safety and tolerability profile of the drug candidate targeting toll-like receptor-4 (TLR4).
NovImmune chief medical officer Cristina de Min said; "Data generated during this Phase I program, coupled with the information from pre-clinical experiments in relevant animal models for human diseases, will build a solid foundation to advance NI-0101 into Phase II studies."
In various preclinical models of arthritis, respiratory inflammation, organ injury and other autoimmune and inflammatory conditions, NI-0101 demonstrated efficacy of TLR4 blockade.
NI-0101 inhibits the ability of the subunits of the receptor complex to function together, thereby suppressing TLR4 signalling in spite of the pro-inflammatory signal.
TLR4 is a well characterised toll-like receptor with an important role as a key mediator of acute and chronic inflammation.
Together with other receptors, TLR4 generally plays a role in fighting invasions by responding to bacterial lipopolysaccharide as a pro-inflammatory stimulus.
When the body faces continuous inflammation, the cells get damaged and the products of damaged cells send pro-inflammatory signals by means of TLR4.
Such signals lead to self damage and inflammation which is the major reason behind several diseases. NI-0101 is designed to interrupt this activity, according to NovImmune.