- 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
Polyphor successfully completes Phase I study with POL6014
6 June 2016 • Author: Victoria White, Digital Content Producer
Polyphor has announced the successful completion of its clinical Phase I study with inhaled POL6014 in healthy volunteers.
The macrocycle drug candidate POL6014 is a highly selective, potent and reversible inhibitor of human neutrophil elastase (hNE). Many severe respiratory diseases are frequently associated with increased hNE levels which may lead to life-threatening deterioration of lung function. The rare lung diseases cystic fibrosis (CF) and alpha-1 antitrypsin deficiency (AATD) represent just two examples of such conditions.
The randomised, double-blind, placebo-controlled dose-escalation Phase I study was designed to investigate the safety, tolerability and pharmacokinetics of inhaled single doses of POL6014 in healthy volunteers. The compound was very well tolerated in all treatment groups. No serious adverse events were reported, and the measured pharmacokinetic parameters increased proportionally with the dose administered using a customised Pari eFlow aerosol inhaler.
“We are very pleased with the outcome of the Phase I clinical study with our macrocycle drug candidate POL6014. The data confirms that the drug can be safely delivered to the human lung by inhalation,” said Dr Leon Hooftman, CMO of Polyphor. “Following the successful completion of this study, we have now initiated two clinical Phase Ib trials investigating the safety, pharmacokinetics, and pharmacodynamics of POL6014 in individuals with cystic fibrosis and non-cystic fibrosis bronchiectasis.”
Polyphor has also reached the first two milestones in its recently announced collaboration with Cystic Fibrosis Foundation Therapeutics Inc (CFFT). The collaboration with CFFT enables Polyphor to accelerate the clinical development of the inhaled elastase inhibitor POL6014 in cystic fibrosis.
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 Butterworth Laboratories Ltd 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 Kaiser Optical Systems Inc. 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