vasopharm GmbH announces the successful completion of a clinical phase I study
Effects of the NO synthase inhibitor VAS203 on renal function in healthy volunteers
Wuerzburg, Germany – 16 June 2017 – vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for acute inflammatory Central Nervous System conditions, today announced the completion of a Phase 1 safety study on its late stage asset, VAS203. This study was conducted in support of the ongoing pivotal Phase III (NOSTRA III) trial of moderate to severe traumatic brain injury, which is currently running in 25 European centres.
The NOSTRA III study involves the infusion of 17 mg/kg VAS 203 over 48 hours. VAS 203 functions as a selective iNOS inhibitor and the Phase II NOSTRA trial demonstrated significant benefit in both short term (Therapy Intensity Level) and long term (eGOS at 6 and 12 months) measures of recovery in TBI patients. The kidney is the only organ in which iNOS is known to have a constitutive role and might thus represent the most sensitive barometer of undesired on target effects of VAS 203. The study enrolled 16 healthy male volunteers in a single centre, double-blind, randomised, placebo controlled, cross-over study. VAS 203 (10 mg/kg) was infused over 6 hours, which is a 4-fold higher infusion rate than that being used in the ongoing NOSTRA III study. There were no drug related adverse events and the safety profile of VAS 203 as examined in this study was excellent.
Christian Wandersee, CEO of vasopharm, commented:
“We are delighted with the outcome of this study which further demonstrates the excellent safety profile of VAS 203. In addition we are further encouraged by the pharmacological profile of the drug and the way in which this supports its activity as a selective inhibitor of iNOS.”
The study was conducted at the Friedrich-Alexander University Erlangen-Nuremberg, Germany, Department of Nephrology and Hypertension. The results have been accepted for presentation at the 54th Congress of the European Renal Association in June 2017 and will submitted for peer reviewed publication in due course.
Renal haemodynamics were assessed using the constant-infusion input-clearance technique with para-aminohippuric acid (PAH) in combination with inulin for renal plasma flow (RPF) and glomerular filtration rate (GFR). Intravenous infusion of VAS 203 resulted in a reduction of RPF and GFR when compared with placebo. The magnitude of these changes was within the range observed under physiological conditions. VAS 203 infusion resulted in an increase in vascular resistance at the pre- glomerular site and a similar but lesser increase in post-glomerular resistance resulting in a decrease in intra-glomerular pressure. There was no change to blood pressure resulting from VAS 203 infusion. These data indicate no clinically relevant systemic effects following treatment with VAS 203, in particular tubular function was not affected. The pharmacological profile of VAS 203 in this study in the kidney corresponds to a drug with properties of selective iNOS inhibition.back