At the presentation of the financial results for the fiscal year ended 30 April 2020 CEO Andrew Crockett of KalVista Pharmaceuticals, Inc. says:
“We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease. We are pleased with our progress with the formulation work for KVD824 to deliver a twice-daily treatment for prevention of HAE attacks. Subjects have begun dosing with these new formulations to obtain additional pharmacokinetic and pharmacodynamic data, and we look forward to providing these data later this year in advance of starting a Phase 2 clinical trial. Patients also continue to be treated in our Phase 2 clinical trial for KVD900 as an on-demand therapy, and we expect data from that trial in the second half of this year.”
Fiscal 2020 and Recent Business Highlights:
- Opened an Investigational New Drug (IND) Application for KVD900 with the U.S. Food and Drug Administration(FDA) to enable clinical development in the United States.
- Presented at The International Symposium on Ocular Pharmacology and Therapeutics (ISOPT). KalVista’s Chief Scientific Officer, Edward P. Feener, PhD, spoke on “Kallikrein-Kinin System in Diabetic Retinopathy – Novel Target.”
- Received Fast Track designation for KVD900 from the FDA, supporting KalVista’s belief in the high level of unmet need in HAE for oral therapy and providing a potentially expedited path to drug approval.
- Selected KVD824 for development as a twice-daily oral prophylactic treatment for HAE. KVD824 is a highly potent and selective plasma kallikrein inhibitor which achieved high exposures and a favorable safety and tolerability profile in a first-in-human study. Additional formulation work on KVD824 is ongoing, and the Company expects to provide this and other data before initiating a Phase 2 clinical trial, which is anticipated to be in the second half of 2020.
- Adjusted expectations for KVD900 data to the second half of 2020 due to the impact of COVID-19, and revised financial guidance that activities are funded into at least early 2022.