Phase I trial of plasma inhibitor for DME started

KalVista Pharmaceuticals has begun a Phase I trial of its plasma kallikrein inhibitor KVD001 for the treatment of diabetic macular oedema (DME).

The study (ClinicalTrials.gov identifier NCT02193113) is being conducted under KalVista's open Investigational New Drug Application (IND) from the US FDA. It is an open label, single ascending dose study to investigate the safety, tolerability and pharmacodynamics of KVD001 delivered by intravitreal injection. The first patients were dosed in August and recruitment is ongoing at five centres in the US.

The study's principal investigator is Dr Jennifer K. Sun, an investigator in the Section on Vascular Biology and an ophthalmologist at Beetham Eye Institute at Joslin Diabetes Center, and an assistant professor at Harvard Medical School, Department of Ophthalmology, Boston, Massachusetts, USA.

Plasma kallikrein is a serine protease that represents an attractive drug target in people with diabetic retinopathy as it is has been shown to contribute to blood vessel leakage and thickening of the retina. The detrimental effects of plasma kallikrein on the retina in patients with diabetes are mediated by mechanisms that are independent of vascular endothelial growth factor (VEGF). KalVista's approach, targeting plasma kallikrein inhibition, has the potential to add to the treatment options for sufferers of DME, including those who are non-responsive to VEGF inhibitors.

For more information, visit www.kalvista.com