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 oral protease inhibitors, today announced that the proposed name ” sebetralstat” has been endorsed by the Expert Committee on International Nonproprietary Names (INN-WHO) of the World Health Organization and the United States Adopted Names Council (AMA-USAN) of the American Medical Association for the drug candidate formerly known as KVD900. Sebetralstat is currently being evaluated in the KONFIDENT Phase 3 study as a potential therapeutic for the on-demand treatment of hereditary angioedema (HAE) attacks.
“We are delighted to announce this next important step in the evolution of sebetralstat as the first potential on-demand oral treatment for HAE,” said Andrew Crockett, CEO of KalVista. “The KONFIDENT study continues to be on track with our expectations, and we have many other activities underway to prepare for the eventual NDA submission. We believe that sebetralstat can be a transformational therapy for people living with HAE.”
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development and commercialization of small molecule oral protease inhibitors for diseases with unmet needs. KalVista has developed a proprietary portfolio of novel small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing sebetralstat as an on-demand oral treatment for acute attacks of HAE and has initiated the KONFIDENT Phase 3 clinical trial. KVD824 is being developed for the prophylactic treatment of HAE, with the KOMPLETE Phase 2 clinical trial ongoing. In addition, KalVista’s oral factor XIIa inhibitor program represents a new generation of therapies with the potential to further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.
For more information on KalVista, please visit www.kalvista.com.
For more information on the on-demand KONFIDENT sebetralstat HAE Phase 3 study, please visit www.konfidentstudy.com.
For more information on the KOMPLETE Phase 2 HAE Prophylaxis Study KVD824, please visit www.kompletestudy.com.
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as: “anticipate”, “have the ‘intent to’, ‘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, including the potential impact of COVID-19, which could cause actual results to differ. materially what we expect. Examples of forward-looking statements include, among other things, the timing or results of communications with the FDA, our expectations regarding the safety and efficacy of our product candidates, and the timing of clinical trials and their results. , our capacity to begin clinical studies or complete ongoing clinical studies, including our KONFIDENT Phase 3 and KOMPLETE Phase 2 clinical trials, and to obtain regulatory approvals for sebetralstat, KVD824 and other candidates in development, the ability of sebetralstat, KVD824 and other candidates in development to treat HAE or DME, as well as future progress and potential success of our oral factor XIIa program. Further information about potential risk factors that could affect our business and financial results is detailed in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended April 30, 2021, our quarterly reports on Form 10-Q, and our other reports we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to update publicly any forward-looking statements, written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.