Novimmune Reports Successful Completion of Phase I trial for NI-0101 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
GENEVA, August 5, 2014 /PRNewswire/ --
Novimmune SA, a company focused on the discovery and development of antibody-based drugs to benefit patients with inflammatory, auto-immune disorders, and cancer announces today 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."
Novimmune SA is a leading drug discovery and development company focused on the creation of antibody-based drugs to benefit patients with inflammatory, auto-immune and other disorders. To date, Novimmune has advanced seven drug candidates to treat a range of conditions. The company has a diverse clinical pipeline that includes NI-0501, NI-0101 and NI-1401.
NI-0501 is an anti-interferon monoclonal antibody that is currently in a Phase II study as a treatment for the orphan disease Hemophagocytic Lymphohistiocytosis, a potentially lethal inflammatory syndrome.
NI-0101 is a first-in-class anti-TLR4 monoclonal antibody. TLR4 is an important receptor on the pathway leading to the activation of the innate immune system. As such, it has been implicated as a target in drug discovery for a range of conditions including rheumatoid arthritis, lung disease, diabetes, and kidney disease. NI-0101 has recently successfully completed a Phase I clinical program and Novimmune intends to initially progress it as potentially the first personalized medicine for rheumatoid arthritis.
NI-1401 is a differentiated anti IL-17 monoclonal antibody that binds the 3 forms of IL-17 A and F. It was licensed to Genentech, prior to Phase I initiation, in 2010. Genentech has assumed all responsibility and costs for development and is expected to announce initiation of a Phase II clinical program in early 2015.
Novimmune has also developed a proprietary bi-specific antibody platform to help further expand its pipeline.
In addition to pursuing additional drug discovery, development and commercialization partnerships, the Company plans to bring selected drugs to market for orphan drug applications.
For further information please contact:
Jack Barbut CEO
Andrew Oakley CFO