– Data examines patient perspectives on treatment outcome measures used in phase 3 KONFIDENT trial of sebetralstat -
– Additional data show the impact of HAE on mental health, daily activities, and quality of life of people living with HAE -
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Oct. 7, 2022--
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today presented new data on patient-preferred on-demand treatment measures in hereditary angioedema (HAE), and on the effects that the disease has on quality of life for people living with HAE, at the 2022 HAEi Global Leadership Workshop in Frankfurt, Germany.
KalVista presented supportive data for the use of the Patient Global Impression of Change (PGI-C) scale as a clinical endpoint to assess the efficacy of on-demand treatments for HAE attacks. Qualitative interviews with people with HAE demonstrated clear preference for the PGI-C (>70%,) over other scales as a measurement tool for patient outcomes. These findings are consistent with post hoc analyses of the KalVista phase 2 clinical trial for sebetralstat, which found PGI-C to be a clinically meaningful measure of efficacy for on-demand treatment of HAE attacks. The combination of clinical meaningfulness and patient preference led KalVista to choose PGI-C as the primary outcome measure for the ongoing phase 3 KONFIDENT clinical trial.
A second KalVista presentation highlighted the significant impact that HAE attacks have on the mental health, daily activities, and quality of life of people living with HAE. This research found that a majority of people with HAE missed out on important events in their lives due to anxiety associated with unpredictability of HAE attacks and that almost half the time, patients feel “less than their 100% self” because of HAE.
“Despite many years of research in HAE, we are still gaining new insights on the impact of HAE attacks on the lives of people with the disease,” said Andrew Crockett, Chief Executive Officer of KalVista. “The goal of this and other research we conduct is to better understand the consequences of HAE and to learn how improve the treatment experience for these patients with our pipeline of oral therapies.”
The following posters were presented at the 2022 HAEi Global Leadership Workshop:
Patient Perspectives on an Optimal Outcome Measure to Assess Efficacy in the Acute Treatment of Hereditary Angioedema Attacks: Dr. Marc A. Riedl, Division of Rheumatology, Allergy and Immunology, University of California San Diego, La Jolla, CA, USA
The Global and Regional Impact of Hereditary Angioedema (HAE) Attacks on Mental Health, Activities of Daily Living and Quality of Life: Dr. Paula J. Busse, Department of Medicine, Division of Clinical Immunology, The Mount Sinai Hospital; New York, New York, USA
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 HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE. 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.
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 trial, and to obtain regulatory approvals for sebetralstat and other candidates in development, the ability of sebetralstat 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, 2022, 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
Source: KalVista Pharmaceuticals, Inc.