Date: 2014-08-05
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Novimmune (Switzerland)
Product: NI-0101
Action
mechanism: monoclonal antibody. NI-0101 is an anti-TLR4 ( toll-like receptor-4) monoclonal antibody. 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.
Disease:
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Immunological diseases
Country:
Trial details:
Latest
news: * On August 5, 2014, Novimmune, a company focused on the discovery and development of antibody-based drugs to benefit patients with inflammatory, auto-immune disorders, and cancer announced the completion of a comprehensive Phase I clinical trial investigating the pharmacokinetics, pharmacodynamics, preliminary tolerability and safety of NI-0101, a first-in-class monoclonal antibody against toll-like receptor 4 (TLR4), in presence and absence in vivo of a TLR4 ligand. In this study, NI-0101, administered by intravenous infusions, was well tolerated with no safety concerns, even in the presence of prolonged inhibition of TLR4 obtained with progressive increases of the NI-0101 dose. Additionally, the administration of NI-0101 to subjects completely prevented the clinical and laboratory effects of an in vivo lipopolysaccharide challenge, while subjects receiving placebo experienced the standard clinical symptoms of LPS. This sophisticated test to evaluate response to an inflammatory stimulus clearly demonstrated the pharmacodynamic effects of the drug in human subjects. * On November 28, 2012, NovImmune has initiated dosing in a Phase I clinical trial of NI-0101. The company 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.”
Cristina de Min, M.D., Chief Medical Officer of Novimmune, commented "We are very pleased with the results of this comprehensive Phase I trial with NI-0101, a first-in-class monoclonal antibody targeting TLR4. When combined with the data generated from our extensive translational and biomarker research program, the results provide a sound background for the initiation of the Phase II proof of concept study in patients suffering from rheumatoid arthritis, subject to regulatory approval. This study will specifically explore the potential for NI-0101 to be the first personalized medicine for this indication."
