Novimmune reports successful completion of Phase I trial for NI-0101

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07.08.2014

The result supports progression of this first-in-class anti-TLR4 monoclonal antibody into clinical proof of concept study as a potential personalized medicine for rheumatoid arthritis.

Novimmune SA, a company focused on the discovery and development of antibody-based drugs to benefit patients with inflammatory, auto-immune disorders, and cancer has 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 (lipopolysaccharide: LPS).

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 LPS 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.

TLR4 is an important receptor on the pathway leading to the activation of the innate immune system. As such it has been proposed as a potential target in drug discovery for a range of conditions including rheumatoid arthritis, lung disease, diabetes, and kidney disease.

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."

Jack Barbut, Chief Executive Officer of Novimmune, added, "We believe that this study is an appropriate initial setting to explore the clinical utility of NI-0101 which may have application in a number of chronic and acute conditions that involve the molecular pathways upon which TLR4 sits."

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