KalVista Pharmaceuticals has started a Phase ll proof-of-concept clinical trial to assess the safety, tolerability, and efficacy of KVD001 for the treatment of diabetic macular edema (DME).

The trial will enrol around 123 patients in the US, who have discontinued treatment with anti-VEGF therapy, as well as significant edema and reduced visual acuity.

The sham-controlled, double-masked trial will also evaluate two dose levels of KVD001, which is a small molecule plasma kallikrein inhibitor given by intravitreal injection for the potential treatment of DME.

During the trial, four intravitreal injections or placebo will be given for three months with a three-month follow-up period.

The trial’s efficacy endpoints cover best corrected visual acuity (BCVA), central subfield thickness (CST), and diabetic retinopathy severity scale (DRSS).

Safety and tolerability of monthly dosing of KVD001 will also be evaluated throughout the trial, which expects to provide top-line results by the second half of 2019.

“We will continue to assess and acquire additional properties to add to our land package.”

KalVista Pharmaceuticals CEO Andrew Crockett said: “After working diligently with Merck since the announcement of our collaboration in October, we are delighted to have begun a Phase ll clinical trial of KVD001 in diabetic macular edema patients.

“We are particularly hopeful that plasma kallikrein inhibition may offer benefits in patients for whom anti-VEGF therapy doesn’t achieve a sufficient response.”

In addition, KalVista has started a Phase l trial of KVD900 to treat oral hereditary angioedema (HAE).

KVD900 is KalVista’s second clinical candidate from a portfolio of oral plasma kallikrein inhibitors to potentially treat HAE.

The Phase l trial is currently screening healthy volunteers to examine the safety, tolerability, and exposure of KVD900. A plasma-based assay will be used to examine the pharmacodynamic effect of the drug.

KalVista seeks to provide new information on the progress of the HAE portfolio, including KVD900, by mid-2018, with an aim to advance at least one additional candidate to the clinic before the year-end.