CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of oral small molecule protease inhibitors, today announced the completion of KOMPLETE Phase 2 clinical trial for KVD824 for the prevention of seizures in people with hereditary angioedema (HAE). This decision was based on the observation of liver enzyme (ALT/AST) elevations in several patients in all treatment groups of the trial. No patient had concomitant elevation of bilirubin levels and all were asymptomatic.
“The health and safety of participants in our clinical trials is of the utmost importance to us,” said Andrew Crockett, CEO of KalVista. “We have made the difficult decision to discontinue KOMPLETE as we have concluded that the emerging safety profile of the current formulation will not meet our requirements for first-rate oral prophylactic therapy. This termination preserves our financial resources and allows us to focus on further advancing sebetralstat through the ongoing Phase 3 program and towards an NDA filing expected in 2024, as well as our emerging oral factor XIIa inhibitor program as a potential once-daily prophylactic treatment for people with HAE.”
The KOMPLETE trial is a Phase 2 clinical trial evaluating KVD824, an investigational oral plasma kallikrein inhibitor designed for seizure prevention in adults living with HAE. Patients in the trial were randomized to one of three treatment groups, each placebo-controlled: 300 mg, 600 mg, 900 mg of KVD824 (or placebo), all given twice daily. A total of 33 patients were enrolled in the trial, of which 7 patients experienced grade 3 or 4 elevations in liver enzymes at times ranging from two to twelve weeks. Elevations were noted in all treatment groups. An additional grade 4 elevation was recorded in one patient at baseline, prior to receiving study drug. KalVista will finalize the trial database and evaluate unblinded efficacy and safety data to determine the potential for further development.
KalVista continues to enroll for the KONFIDENT Phase 3 trial evaluating sebetralstat (formerly KVD900) as a potential on-demand oral treatment for HAE attacks, with data expected in the second half of 2023. Sebetralstat is a compound distinct from KVD824, and no treatment-related elevations of liver enzymes in patients have been observed in all clinical studies of sebetralstat, including the ongoing KONFIDENT Phase 3 trial.
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 HAE attacks and is entering the KONFIDENT Phase 3 clinical trial. Additionally, KalVista’s oral factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of people with HAE. 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 trial, please visit www.konfidentstudy.com.
Forward-looking statements
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’, ‘probable’, ‘ 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 from 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 ability to commence studies clinical trials or to complete ongoing clinical studies, including our KONFIDENT Phase 3 trial, and to obtain regulatory approvals for sebetralstat and other candidates in development, the ability of sebetralstat and other candidates in development to treat the HAE or DMO, as well as the 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 on April 30, 2022, 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.
