– Sebetralstat 300 mg achieved beginning of
symptom relief in 1.6 hours –
– Safety profile comparable to placebo –
– On track for submission of new drug
application to U.S. FDA in the first half of 2024 –
– Conference call to discuss trial results
today at 8:30 a.m. ET –
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage
pharmaceutical company focused on the discovery, development, and
commercialization of small molecule protease inhibitors, today
announced positive results from the phase 3 KONFIDENT clinical
trial demonstrating statistically and clinically significant
efficacy of sebetralstat as oral on-demand therapy for hereditary
angioedema (HAE). KONFIDENT was the largest and most representative
trial ever conducted in HAE, and included adolescents, patients
using long-term prophylaxis, and all attack severities and
locations.
The clinical trial met all primary and key secondary endpoints
and demonstrated a favorable safety profile. HAE attacks treated
with both 300 mg and 600 mg of sebetralstat achieved the primary
endpoint of beginning of symptom relief significantly faster than
placebo (p<0.0001 for 300 mg, p=0.0013 for 600 mg). The median
time to beginning of symptom relief was 1.61 hours with
sebetralstat 300 mg (CI 1.28, 2.27), 1.79 hours with sebetralstat
600 mg (CI 1.33, 2.27) and 6.72 hours with placebo (CI 2.33,
>12).
Consistent with previous studies, sebetralstat was
well-tolerated, with a safety profile similar to placebo. There
were no patient withdrawals due to any adverse event and no
treatment-related serious adverse events (SAEs) were observed.
Treatment-related adverse event rates were 2.3% for 300 mg
sebetralstat, 2.2% for 600 mg sebetralstat, and 4.8% for
placebo.
“We are thrilled to announce positive phase 3 results for the
KONFIDENT trial, which we believe position sebetralstat to become
the first oral, on-demand therapy for the treatment of HAE. These
clinically meaningful results represent a potentially significant
advance for people living with HAE. If approved, sebetralstat may
offer a compelling treatment option for patients and their
caregivers given the long-standing preference for an effective and
safe oral therapy that provides rapid symptom relief for HAE
attacks,” said Andrew Crockett, Chief Executive Officer of
KalVista.
Mr. Crockett added, “Most importantly, we want to thank the
people living with HAE, their families, and the investigator teams
around the world who supported KONFIDENT and made it the largest
clinical trial ever conducted in HAE. We look forward to submitting
a new drug application for sebetralstat to the U.S. FDA in the
first half of 2024 and in the EU and Japan later this year.”
Primary and key secondary endpoints were analyzed in a fixed,
hierarchical sequence and adjusted for multiplicity. Key secondary
endpoints showed:
- Attacks treated with sebetralstat 300 mg or 600 mg achieved a
significantly faster time to a reduction in attack severity from
baseline, compared to placebo (p=0.0036 for 300 mg and p=0.0032 for
600 mg)
- Attacks treated with sebetralstat 300 mg or 600 mg demonstrated
a significantly faster time to complete attack resolution, compared
to placebo (p=0.0022 for 300 mg and p<0.0001 for 600 mg)
“These highly encouraging phase 3 results show that sebetralstat
provided rapid symptom relief in a broad HAE population that
reflects my clinical practice,” said Danny Cohn, MD, PhD,
Department of Vascular Medicine, University of Amsterdam, and
principal investigator for the KONFIDENT phase 3 trial. “If
approved, sebetralstat could transform the management of HAE.”
“With no new on-demand therapies for HAE approved for nearly a
decade, having a safe and effective oral, on-demand treatment for
HAE attacks could be immensely valuable in addressing unmet needs
and reducing the treatment burden associated with current
injectable treatments,” said Marc A. Riedl, MD, professor of
medicine and clinical director, U.S. Hereditary Angioedema
Association Center at the University of California, San Diego, and
an investigator for the KONFIDENT phase 3 trial. “Against the
backdrop of patient needs and opportunities, the results of this
trial with sebetralstat are extremely encouraging for the HAE
community.”
The Company plans to present phase 3 data for the KONFIDENT
trial at the annual meeting of the American Academy of Allergy
Asthma and Immunology (AAAAI) on February 25, 2024.
Webcast Details KalVista will host a webcast today at
8:30am ET. In conjunction, the Company will post a presentation
with data from the phase 3 KONFIDENT trial of sebetralstat on the
investors section of the company website. Stockholders and other
interested parties may participate in the call by following the
instructions below. The live webcast can be accessed on the Event
Calendar portion of the KalVista investor page. A replay will be
available on the KalVista website shortly after completion of the
event and will be archived for up to 30 days.
Webcast Link:
https://edge.media-server.com/mmc/p/mzfxtn9e
Participant Call Link:
https://register.vevent.com/register/BI9a15a8c461b94eca9b3f649b83cdec60
About the KONFIDENT Phase 3 Trial The KONFIDENT phase 3
trial was a randomized, double blind, event-driven, crossover
clinical trial evaluating the efficacy and safety of sebetralstat
300 mg and 600 mg versus placebo for the on-demand treatment of
HAE. The trial enrolled a total of 136 adult and adolescent HAE
patients from 66 clinical sites across 20 countries, making it the
largest clinical trial ever conducted in HAE. In the trial,
patients treated each eligible attack with up to two doses of study
drug, and each patient could treat up to three attacks over the
course of the study. The trial included type 1 and type 2 HAE
patients who had at least two attacks in 90 days prior to
enrollment.
About Sebetralstat Discovered by KalVista, sebetralstat
is an investigational novel, oral plasma kallikrein inhibitor for
the on-demand treatment of hereditary angioedema (HAE).
Sebetralstat received Fast Track and Orphan Drug designations from
the U.S. FDA, as well as Orphan Drug Designation and an approved
Pediatric Investigational Plan from the European Medicines Agency
(EMA).
About Hereditary Angioedema Hereditary angioedema (HAE)
is a rare genetic disease resulting in deficiency or dysfunction in
the C1 esterase inhibitor (C1INH) protein and subsequent
uncontrolled activation of the kallikrein-kinin system. People
living with HAE experience painful and debilitating attacks of
tissue swelling in various locations of the body that can be
life-threatening depending on the location affected. All currently
approved on-demand treatment options require either intravenous or
subcutaneous administration.
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 our Phase 3 KONFIDENT 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/20240213650216/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
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