Phase 1 Trial of Oral Therapy KVD900 for Hereditary Angioedema Underway

An oral candidate for the treatment of hereditary angioedema (HAE) has begun a phase 1 clinical trial, KalVista Pharmaceuticals recently announced.

HAE is a rare genetic disease characterized by recurrent episodes of severe swelling (angioedema) and potential pain, nausea, and vomiting. It occurs in about 1 in 10,000 to 1 in 50,000 people. The condition mostly affects the hands, feet, face, gastrointestinal tract, and airway (throat).

KalVista is developing small molecule inhibitors of the plasma enzyme kallikrein, which is involved in inflammation and pain and may lead to increased vascular permeability and edema, or swelling.

HAE patients have a defect in the gene coding for an inhibitor of kallikrein, which results in uncontrolled plasma kallikrein activity and elevated levels of the inflammatory mediator bradykinin.

KVD900 is the second candidate for the treatment of HAE out of KalVista’s collection of oral plasma kallikrein inhibitors. The first candidate, KVD818, has already completed a Phase 1 study. The company plans to develop and test multiple oral molecules in its pursuit of a best-in-class therapy for HAE patients. Ultimately, this strategy may also lead to the development of multiple molecules for unmet needs in both prophylactic (preventive) and on-demand market segments.

The Phase 1 trial of KVD900 is currently screening healthy volunteers to assess its safety, tolerability, and pharmacodynamic effect (the therapy’s effects in the body). The company plans an update on the status and progress of its HAE portfolio in mid-2018.

“2018 will be an exciting year for our hereditary angioedema portfolio, with our second oral plasma kallikrein inhibitor candidate in a Phase 1 clinical trial and an anticipated regulatory filing for a third candidate before year-end,” Andrew Crockett, CEO at KalVista, said in a press release.

In addition to the study on HAE, KalVista is evaluating the safety and tolerability of intravitreal injections (inside the eye) of KVD001 in a double-blind Phase 2 trial for the treatment for diabetic macular edema, a sight-threatening disease caused by leaking blood vessels that lead to accumulation of fluid in the macula.

This Phase 2 trial is the result of a collaboration with Merck. KalVista anticipates results in the second half of 2019.

Both HAE and diabetic macular edema trials started in December 2017.