- 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
Phase 2a clinical trial results for emixustat hydrochloride published
4 June 2015 • Author: Victoria White
Results from a Phase 2a clinical trial of Acucela’s emixustat hydrochloride (emixustat) in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD) have been published.
Emixustat, the first internally developed compound by Acucela, is orally dosed, targets the visual cycle, and is in development for the potential treatment of GA associated with dry AMD for which there is currently no US Food and Drug Administration (FDA)-approved therapy available.
Emixustat achieved dose-dependent pharmacologic activity in the retina
“We are pleased about the publication of the Phase 2a study data,” Pravin U. Dugel, MD, Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California, said. “The data…showed that emixustat achieved dose-dependent pharmacologic activity in the retina of patients with geographic atrophy.”
The study was designed to assess the safety, tolerability, and pharmacodynamics of emixustat in subjects diagnosed with GA. Seventy-two subjects were randomised to receive one of four emixustat doses (2, 5, 7, or 10 mg once daily) or placebo for a 90-day treatment period. Biologic activity of emixustat in the retina was measured by electroretinography (ERG). Safety evaluations included analysis of adverse events and ophthalmic examinations. The ERG data showed a dose-dependent pharmacologic effect of emixustat, consistent with the proposed mechanism of action. The authors noted that most systemic adverse events (AEs) observed in the clinical trial were not considered treatment related and that ocular AEs were mild to moderate in severity. The limitations of the study include its small sample size and the proportion of subjects who did not complete the entire 90-day dosing period.
The long-term safety and clinical effect of emixustat on disease progression is currently being evaluated in an ongoing Phase 2b/3 study.
The results are published in the June online edition of RETINA: The Journal of Retinal and Vitreous Diseases.
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 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) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics