Date: 2014-08-20
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patients
Company: KalVista Pharmaceuticals (UK)
Product: KVD001
Action
mechanism: KVD001 is a small molecule plasma kallikrein inhibitor for intravitreal (IVT) dosing. IVT plasma kallikrein inhibitors are expected to be efficacious in both improving symptoms of the disease as well as preserving visual acuity and slowing disease progression. Direct injection into the eye couples a high drug concentration at the desired site of action with a low systemic exposure resulting in the potential for a faster pre-clinical development timeline. Furthermore, with the correct formulation, the drug can be retained within the vitreous for a prolonged period, thereby reducing the frequency of administration.
Disease: diabetic macular edema
Therapeutic area: Metabolic diseases - Ophtalmological diseases
Country: USA
Trial
details: This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. (NCT02193113).
Latest
news: * On August 20, 2014, KalVista Pharmaceuticals, an ophthalmology company with a focus on diabetic macular edema (DME), announced that it has begun a Phase I, First in Human, trial of its novel plasma kallikrein inhibitor, KVD001, for the treatment of DME. The study’s Principal Investigator is Dr. Jennifer K Sun of the Beetham Eye Institute, Joslin Diabetes Center; Harvard Medical School Department of Ophthalmology, Boston, MA and is being conducted under KalVista’s open Investigational New Drug Application (IND) from the FDA. KVD001 has been advanced under a research partnership between KalVista and JDRF. First patients were dosed in August and recruitment is ongoing at five centers in the US. 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 through the collaborative work of Drs. Edward P Feener and Lloyd Paul Aiello at the Joslin Diabetes Center. 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), which has been an area of intense recent interest as a target for treating DME. However, while intravitreal VEGF inhibitors have shown clear benefit in clinical trials in many patients through reducing macular edema and increasing visual acuity, a substantial proportion of DME patients do not respond fully to anti-VEGF treatment. KalVista’s approach, targeting plasma kallikrein inhibition, has the potential to add to the treatment options for sufferers of DME including those that are non-responsive to VEGF inhibitors. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many patients.
