In an operational update released together with the financial results for the fiscal year ended 30 April 2021, KalVista Pharmaceuticals, Inc. CEO Andrew Crockett says:
“This past fiscal year we made great strides in providing data to support the development of the candidates in our oral HAE franchise. Now we are at an important inflection point as we work with regulatory agencies to both finalize the Phase 3 program for KVD900 and begin the Phase 2 clinical trial of KVD824. With our financing earlier this year we are well-capitalized to focus on execution of these activities, and we look forward to providing additional details on the trials later this year as they begin.”
Fiscal 2021 and Recent Business Highlights:
- Reported positive results for KVD900 in a Phase 2 clinical trial demonstrating statistically and clinically significant responses across primary and secondary endpoints as an oral on-demand treatment for HAE attacks. An end-of-Phase 2 meeting has been scheduled late in the third quarter of calendar year 2021 with the Food and Drug Administration (FDA) to review the planned KVD900 Phase 3 program.
- Provided data on KVD824 as a twice-daily oral candidate for prophylactic treatment of HAE. Work to optimize the exposure profile of KVD824 yielded a formulation that maintained the plasma concentrations that KalVistabelieves are required to compete with approved injectable therapies, while showing an encouraging safety and tolerability profile in up to 14 days of dosing.
- Announced a novel oral Factor XIIa inhibitor program as the next area of focus. KalVista’s internal research team has discovered multiple series of oral Factor XIIa inhibitors, initially being advanced with the potential to provide the next generation of HAE therapeutics. Investigational New Drug (IND)-enabling studies for oral Factor XIIa inhibitor candidates are expected to commence in calendar year 2021.
- Submitted an IND for a Phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks. The U.S. FDA notified the Company in a letter that it has placed a clinical hold on the proposed Phase 2 clinical trial of KVD824. The FDA letter requested further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2 trial, as well as refinements to the intended KVD824 Phase 2 study protocol. The Company intends to submit its response to the FDA during the third quarter of calendar year 2021. KalVista also continues to progress regulatory filings for other countries where it plans to initiate sites for the KVD824 Phase 2.