KalVista Pharmaceuticals Presents Data Demonstrating KVD900 Achieves Rapid Exposure and Improves Outcomes as Oral On-Demand Treatment of HAE

Rhea-AI Summary

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) presented Phase 2 data for KVD900 at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting. KVD900 is an oral treatment for hereditary angioedema (HAE) that demonstrated rapid absorption, with significant symptom relief observed faster than placebo (1.6 hours vs 9.0 hours, p<0.0001). The findings suggest KVD900 could significantly improve patient outcomes during HAE attacks. The data also indicates strong agreement between Patient Global Impression of Change and other reported outcomes, underscoring its clinical relevance.

Positive

• KVD900 demonstrated rapid absorption with effects noticeable within 15 minutes.
• Median symptom improvement time was significantly shorter with KVD900 (1.6 hours) compared to placebo (9.0 hours).
• Improved patient-rated symptom relief at 12 and 24 hours compared to placebo.
• High sensitivity (97%) for composite measures indicating clinically meaningful improvements.

Negative

• None.

– KVD900 Phase 2 data presented at American College of Allergy, Asthma & Immunology Annual Scientific Meeting –

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 announced data presented at American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting. Data presentations included an oral presentation and poster presentation on Phase 2 data for KVD900, KalVista’s lead program for oral on-demand treatment of hereditary angioedema (HAE) attacks.

“Current guidelines recommend effective on-demand therapy for every patient with HAE to reduce symptom severity and attack duration,” said Jonathan Bernstein, FAAAAI, FACAAI, FACP, M.D., University of Cincinnati College of Medicine and Bernstein Clinical Research Center, LLC. “Treatment of HAE attacks with KVD900 achieved rapid plasma exposure which was associated with faster improvements in initial symptom relief compared with placebo. As the first oral on-demand treatment to demonstrate this early therapeutic effect for patients, KVD900 may represent a remarkable advancement for management of the disease.”

Oral Presentation: On-Demand Oral Treatment with KVD900 for HAE Attacks Achieves Rapid Exposures and Improves Patient Outcomes

• KVD900 was rapidly absorbed, with measurable concentrations detected within 15 minutes
• Plasma levels reached peak concentration within 1 hour of administration
• Median time to symptom improvement was significantly shorter with KVD900 than with placebo (1.6 vs 9.0 hours, p<0.0001), as indicated by the Patient Global Impression of Change (PGI-C) scale
• A significantly higher percentage of patients also rated their HAE attack symptoms as improved within 12 and 24 hours with KVD900 compared with placebo

Poster Title: Relationship Between PGI-C Scale and Other Patient Reported Outcomes (PROs) in KVD900 Trial in HAE

• In a Phase 2 trial, several PROs were collected to capture the patient experience
• 60 patients completed treatment for at least one attack (n=113 attacks). PGI-C scoring of “a little better” or higher at two consecutive timepoints had 97% sensitivity for composite visual analogue scale (VAS) and Patient Global Impression of Severity (PGI-S) improvement.
• Moderate to substantial agreement between PGI-C and the other measures suggests that improvement on PGI-C was clinically significant from the patients’ perspective.

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. 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 KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021, demonstrating statistical and clinical significance across all endpoints. 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, please visit www.kalvista.com.

Forward-Looking Statements

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, our expectations about efficacy of our product candidates, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 2 KOMPLETE clinical trial, the ability of KVD900, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211108005569/en/

KalVista Pharmaceuticals, Inc.

Leah Monteiro

Senior Director, Corporate Communications & Investor Relations

857-999-0808

leah.monteiro@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What were the results of the KVD900 Phase 2 trial presented by KalVista Pharmaceuticals?

The Phase 2 trial for KVD900 showed rapid absorption and significant improvement in HAE symptoms compared to placebo, with median relief time of 1.6 hours.

How does KVD900 compare to placebo in terms of symptom relief?

KVD900 provided symptom relief significantly faster (1.6 hours) than placebo (9.0 hours) during hereditary angioedema attacks.

What is the significance of the data presented at the ACAAI meeting for KALV?

The data highlights KVD900's potential as a first oral on-demand treatment for HAE, suggesting it may significantly enhance patient management.