– Sebetralstat data examines efficacy by attack location and population PK comparisons –
– Preclinical data for oral Factor XIIa inhibitor shows durable suppression of kallikrein-kinin system -
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, has presented data for its oral on demand plasma kallikrein (PKa) inhibitor and Factor XIIa (FXIIa) programs at the EAACI2022 conference in Prague, Czech Republic.
KalVista presented data showing sebetralstat was an effective treatment for both peripheral and abdominal attacks with 80% of attacks achieving symptom relief within 12 hours, regardless of attack location. Population pharmacokinetic (PK) data showed that the PK of sebetralstat did not appear to be affected by consumption of a normal meal prior to dosing compared with taking the dose after fasting. Furthermore, PK modeling supports the use of sebetralstat in adolescents 12 years and older without dose adjustment.
Animal model data with oral FXIIa inhibitor KV998086 showed the compound protected mice from kallikrein-kinin system (KKS) mediated edema. KV998086 blocked the generation of FXIIa & PKa and prevented HK cleavage in a dose-responsive manner. Pharmacokinetic studies showed that oral KV998086 displayed high bioavailability. Inhibition of the KKS with KV998086 may provide an opportunity for once-daily HAE prophylaxis as well as having potential to treat other KKS-mediated diseases.
“The population PK study is important for our sebetralstat program,” said Andrew Crockett, Chief Executive Officer of KalVista. “It expands the population we can target for treatment in our Phase 3 KONFIDENT trial without having to use multiple dose regimens. Additionally, the preclinical data with our oral FXIIa inhibitor once again shows the promise of this novel class of compounds, which will be important to our company’s future even beyond HAE.”
The following presentations occurred at EAACI2022:
- Identification of novel potent oral Factor XIIa inhibitors that block kallikrein kinin system activation in a preclinical model of angioedema: Allen C. Clermont, Director, Preclinical Pharmacology, KalVista Pharmaceuticals, Inc.
- Efficacy of the Oral Plasma Kallikrein Inhibitor, Sebetralstat, by Attack Location in a Phase 2 Clinical Trial in Patients with Hereditary Angioedema: Emel Aygören-Pürsün, MD, Department for Children and Adolescents, University Hospital Frankfurt, Germany.
The following posters were presented at EAACI2022:
- Population Pharmacokinetic Analysis of KVD900 in Healthy Adult Volunteers and Patients with Hereditary Angioedema Predicts Similar Exposure in Adolescent Patients: Sinisa Savic, PhD, University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.
- Efficacy and Safety of the Oral Plasma Kallikrein Inhibitor, Sebetralstat, in Adolescent and Adult Patients with Hereditary Angioedema: Phase 3 Study Design: Andrea Zanichelli, MD, Department of Internal Medicine, ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco-University of Milan, Italy.
Links to all posters and presentations can be found on the KalVista website under “Publications”.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. 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 oral on-demand therapy for acute HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. KVD824 is in development for prophylactic treatment of HAE, with the Phase 2 KOMPLETE clinical trial underway. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may 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 about KalVista, please visit www.kalvista.com.
For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.
For more information on the KVD824 HAE prophylaxis Phase 2 KOMPLETE study, please visit www.kompletestudy.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, including the potential impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT and Phase 2 KOMPLETE 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, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in 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 that we may make 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.
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KalVista Pharmaceuticals, Inc.
Vice President, Corporate Communications