KalVista Pharmaceuticals Presents Additional Phase 3 KONFIDENT Data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting
February 26 2024 - 6:30AM
Business Wire
– 94% of attacks required only one dose to
achieve primary endpoint -
– Further analyses demonstrate efficacy across
all levels of attack severity -
– Additional safety data reinforces flexibility
of dosing -
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 that it presented additional data on its phase 3
KONFIDENT trial for sebetralstat, including a more in-depth
analysis of sebetralstat efficacy and safety at the 2024 American
Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting
taking place in Washington, DC.
The following late-breaking presentation occurred at AAAAI
2024:
- Sebetralstat for On-demand Treatment of Hereditary
Angioedema Attacks: Results of the Double-blind, Placebo-controlled
Phase 3 KONFIDENT Trial: Marc Riedl, Division of Rheumatology,
Allergy and Immunology, University of California San Diego, San
Diego, California, United States
Among the additional efficacy analyses from KONFIDENT presented
during the poster session were the proportions of attacks reaching
the primary (time to beginning of symptom relief) and key secondary
endpoints (time to reduction in attack severity and time to
complete attack resolution) without the use of a second dose.
Proportions of attacks that reached the beginning of symptom relief
without a second dose were 93.9% and 95.8% with sebetralstat 300 mg
and 600 mg, respectively, while the proportions of attacks reaching
a reduction in severity without a second dose were 90.9% and 95.9%
with sebetralstat 300 mg and 600 mg, respectively. These
proportions were 91.9% and 84.8% for complete attack resolution.
Additional safety analyses demonstrated that the safety profiles
associated with one dose or two doses of sebetralstat 300 mg or 600
mg were comparable to placebo.
Data presented as a supplement also showed that the median time
to all endpoints was shorter for attacks with higher initial
severity, at both dose levels. Median times to beginning of symptom
relief for moderate attacks were 1.6 hours for 300 mg and 2.1 hours
for 600 mg, and for severe attacks the median times were 1.4 and
1.5 hours, respectively. Similarly, time to reduction in attack
severity was also shorter for attacks that were rated moderate or
severe at baseline, with median times of 5.0 and 3.3 hours,
respectively, for moderate attacks and 1.3 and 1.4 hours,
respectively, for severe attacks.
“Given the unrestricted use of a second dose of oral
sebetralstat in KONFIDENT, it was important to understand the
proportion of attacks that achieved the primary and key secondary
endpoints without a second dose. What we observed was that the vast
majority of attacks that successfully met the three endpoints did
so with a single dose of sebetralstat,” said Marc A. Riedl, MD,
Professor of Medicine and Clinical Director, US Hereditary
Angioedema Association Center at the University of California, San
Diego.
“If approved, we believe that a single dose of sebetralstat 300
mg would appear to be appropriate for most HAE attacks. However,
the ability to dose flexibly depending on the characteristics of a
specific attack is supported by the safety and tolerability
observed with repeated dosing at both 300 mg and 600 mg,” said
Andrew Crockett, Chief Executive Officer of KalVista. “We believe
that these additional efficacy and safety data only strengthen the
case for sebetralstat to become the first, oral on-demand treatment
available to the HAE community.”
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 disclosed positive phase 3 data
for the KONFIDENT trial for its oral, on-demand therapy
sebetralstat in February 2024. The Company anticipates submitting a
new drug application to the U.S. FDA for sebetralstat in the first
half of 2024 and expects to file for approval in Europe and Japan
later in 2024. 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 and other
diseases.
For more information about KalVista, 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 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 the
KONFIDENT-S trial, and to obtain regulatory approvals for
sebetralstat and other candidates in development, the success of
any efforts to commercialize sebetralstat, the ability of
sebetralstat and other candidates in development to treat HAE or
other diseases, 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, 2023, 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/20240226691447/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice
President, Corporate Communications (201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Mar 2024 to Apr 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Apr 2023 to Apr 2024