NovImmune initiates Phase I clinical study with a new antibody

NovImmune SA initiated dosing in a Phase I clinical trial of NI-0101, a monoclonal antibody drug candidate targeting toll-like receptor-4 (TLR4).

NI-0101 was discovered and developed by NovImmune, and has broad potential applications. NovImmune has demonstrated efficacy of TLR4 blockade in a range of preclinical models of arthritis, respiratory inflammation, organ injury, as well as other autoimmune and inflammatory conditions. The first-in-human study in healthy volunteers will generate information for pharmacokinetic and pharmacodynamic properties as well as safety and tolerability data.

NovImmune's 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."

TLR4 is a well characterized toll-like receptor with extensive publications outlining its role as a key mediator of acute and chronic inflammation. NI-0101 is the first anti-TLR4 antibody drug candidate to enter development. By inhibiting the ability of the subunits of the receptor complex to function together, NI-0101 inhibits TLR4 signaling regardless of the pro-inflammatory signal, making it an attractive drug candidate for a range of applications.