- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Aridis expands Phase 2a trial of AR-301 into the US
9 July 2015 • Author: Victoria White
The US Food and Drug Administration (FDA) has accepted Aridis Pharmaceuticals’ Investigational New Drug (IND) application for AR-301 (Salvecin).
AR-301 is a fully human anti-Staphylococcal α-toxin IgG1 monoclonal antibody being developed for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant MRSA strains.
Acceptance of the IND application enables Aridis to expand and accelerate its current Phase 2a study of AR-301 into the United States. The study is currently underway in three European countries, with further expansion into the United Kingdom also planned. Top-line results from the accelerated Phase 2a study are expected in the first half of 2016.
Paul-Andre de Lame, M.D., Chief Medical Officer of Aridis, stated, “We believe AR-301 can positively impact the outcome of S. aureus infections by improving survival rates and/or shortening the time a patient spends in the intensive care unit (ICU), or overall hospital stay.”
AR-301 binds and neutralises S. aureas alpha toxin
Vu Truong, Ph.D., founder and Chief Executive Officer, added, “This is important because we believe it could potentially save thousands of lives per year and significantly reduce hospital infrastructure-related costs. We look forward to completing this study and reporting top-line results in the first half of 2016.”
The European Phase 2a clinical trial is a randomised, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous administration of AR-301 in patients with severe pneumonia caused by S. aureus.
AR-301 was discovered by screening B-cell lymphocytes of a patient with confirmed S. aureus infection and developed using Aridis’ proprietary MAbIgX® technology. It binds and neutralises S. aureus alpha toxin, preventing alpha toxin-mediated destruction of human cells. There is no anti-infective on the market that specifically neutralises the pathogenic affects brought about by S. aureus toxins and Aridis believes that this mechanism of action complements the bacterial killing properties of many conventional antibiotics, as the bacterial toxins left behind following antibiotic-mediated killing can still be neutralised by AR-301.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics