“Based upon the progress of the ongoing KVD900 Phase 2 clinical trial, we expect to announce data from that trial in the second quarter of this year,” says Andrew Crockett, CEO of KalVista Pharmaceuticals, Inc.
“We are also pleased to announce the selection of KVD824 for development as an oral prophylactic treatment for HAE. Based on preclinical formulation work conducted, we see evidence that KVD824 can achieve the properties we believe necessary for high efficacy as a twice-daily treatment for prevention of HAE attacks. After completing additional clinical work to optimize the exposure profile, we plan to commence a Phase 2 clinical trial in the second half of this year. KVD824 could be an excellent companion to KVD900’s profile as an on-demand therapy to together serve all of the needs of HAE patients.”
In developing the strategy for its oral HAE franchise, KalVista has conducted extensive patient, physician and payer research to identify the key needs in the market. Oral therapy remains the highest unmet need according to all stakeholders, with 93% of patients surveyed by KalVista expressing a willingness to switch to oral therapy for both on-demand and prophylactic usage. Importantly however, the survey data shows that patients are not prepared to accept significantly reduced efficacy with a switch to oral therapy. The survey also indicated that twice-daily dosing would have little impact on willingness to switch compared to once-daily.
KalVista anticipates that KVD824 can meet the efficacy and safety needs of patients as an oral prophylactic treatment. 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. KalVista intends to investigate twice-daily dosing in the planned Phase 2 trial to maximize efficacy while maintaining the convenience of an oral therapy.