KalVista Pharmaceuticals, Inc. announced the initiation of two clinical trials: 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. Both trials commenced in December 2017, in line with KalVista's previously stated 2017 objectives. 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 United States 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. Four intravitreal injections, or sham, will be administered over three months with a three month follow up period. Efficacy endpoints include best corrected visual acuity (BCVA), central subfield thickness (CST), and the diabetic retinopathy severity scale (DRSS). The safety and tolerability of monthly dosing of KVD001 will also be assessed. Top-line results are expected in the second half of 2019. KVD900 is the second clinical candidate from a portfolio of oral plasma kallikrein inhibitors for potential treatment of HAE. KalVista'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. 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. KalVista expects to provide an update on the status and progress of the HAE portfolio, including KVD900, in mid-2018, with a goal to advance at least one additional candidate to the clinic before the end of 2018.