- 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
Successful Phase 1 results for cardiometabolic disease drug PXS-4728A
22 September 2015 • Author: Victoria White
Pharmaxis has announced positive results for all primary and secondary endpoints from the Phase 1 clinical trial of PXS-4728A.
PXS-4728A was acquired by Boehringer Ingelheim in May to develop as a treatment for cardiometabolic diseases such as Non-Alcoholic Steatohepatitis (NASH). PXS-4728A is a highly selective inhibitor of an enzyme and adhesion protein which reduces inflammation and oxidative stress.
Further to the Phase 1a single ascending dose stage that reported positive results in April 2015, this Phase 1b multiple ascending dose stage was conducted in 24 healthy subjects divided into three groups with each taking active or placebo once a day for 14 days. Three different dosages of PXS-4728A were trialled.
Once daily oral dosing of PXS-4728A for 14 days at doses between 3 and 10 mg was found to be safe and well tolerated. The data confirmed the high oral bioavailability of PXS-4728A and showed these low doses are efficacious in inhibiting the enzyme and cause a long lasting inhibition suggesting PXS-4728A can be dosed once a day.
Phase 1 results enable Boehringer Ingelheim to proceed with development programmeme of PXS-4728A
These positive Phase 1 results enable Boehringer Ingelheim to proceed with further development of the programme.
Pharmaxis CEO Mr Gary Phillips said, “NASH is a disease that is becoming more prevalent and there is a clear need for more effective therapies. PXS-4728A inhibits an enzyme which has been highlighted in independent peer reviewed publications as an excellent target to treat NASH and this first human trial of the drug confirms its strong pre-clinical profile translates into human studies. It is rare to be able to demonstrate effective target engagement in a phase 1 study so the fact that the long lasting enzyme inhibition seen in the phase 1a study was reinforced when given once a day for 14 days adds to our confidence in PXS-4728A. We now look forward to the next value appreciating steps as the clinical development programme proceeds with Boehringer.”
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 Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics