9 January 2018 - - Cambridge, Massachusetts-based small molecule protease inhibitors developer KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) initiated two clinical trials in December 2017: a Phase 2 proof-of-concept clinical trial evaluating the safety, tolerability, and efficacy of KVD001 as a treatment for diabetic macular edema (DME), as well as a Phase 1 trial for KVD 900, the second candidate in the oral hereditary angioedema (HAE) portfolio, the company said.
KVD001 is a small molecule plasma kallikrein inhibitor administered by intravitreal injection for the potential treatment of DME. The Phase 2 trial will consist of approximately 123 patients in the US who have discontinued treatment with anti-VEGF therapy, and who still have significant edema and reduced visual acuity.
This sham-controlled, double-masked clinical trial will evaluate two dose levels of KVD001. Efficacy endpoints include best corrected visual acuity, central subfield thickness, and the diabetic retinopathy severity scale.
The safety and tolerability of monthly dosing of KVD001 will also be assessed.
KVD900 is the second clinical candidate from a portfolio of oral plasma kallikrein inhibitors for potential treatment of HAE. The Phase 1 trial of KVD900 is actively screening healthy volunteers to evaluate the safety, tolerability and exposure of the drug candidate, and a plasma-based assay will be used to assess the pharmacodynamic effect of KVD900.
The company's strategy is to develop and evaluate multiple oral molecules in pursuit of a best-in-class therapy for HAE patients. This portfolio approach may also lead to development of multiple molecules to address unmet need in both prophylactic and on-demand market segments.
KalVista is focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema, and inflammation.