CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an update on its franchise of oral plasma kallikrein inhibitors for treatment of hereditary angioedema (HAE).
“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,” said Andrew Crockett, Chief Executive Officer of KalVista. “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.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body’s inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second quarter of 2020. KVD824 is in development for prophylactic treatment of HAE and is anticipated to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.
For more information, please visit www.kalvista.com.
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, potential future clinical trial timing and results for KVD900 and KVD824. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 15, 2019 and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.