– Submissions support KalVista’s mission of
building a global footprint for sebetralstat to address the
significant unmet need for people with HAE worldwide –
– If approved, sebetralstat will be the first,
oral on-demand treatment for HAE –
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) today announced
Marketing Authorization Application (MAA) submissions to the
regulatory authorities in the United Kingdom, Switzerland,
Australia, and Singapore for sebetralstat, a novel, investigational
oral plasma kallikrein inhibitor for the on-demand treatment of
hereditary angioedema (HAE) attacks in adults and adolescents aged
12 years and older. The four MAAs have been submitted via the
Access Consortium framework for which KalVista has obtained a
four-way work-sharing agreement by the Medicines and Healthcare
product Regulatory Agency, Swissmedic, the Therapeutic Goods
Administration and Health Sciences Authority. The Access Consortium
is designed to maximize regulatory collaboration across countries
and support a timely review process.
“Today’s news, which comes only a few weeks following our
announcements regarding our U.S. FDA PDUFA date of June 17 and
validation of our MAA by EMA, further underscores our focus and
dedication to getting sebetralstat to as many people living with
HAE as possible,” said Ben Palleiko, CEO of KalVista. “To serve
that goal, we are building a global commercial presence to provide
the greatest possible access to potentially the first oral
on-demand treatment for this debilitating disease. I am proud of
the KalVista team for their dedication and continued hard work
submitting these additional MAAs.”
The MAA submissions are supported by previously disclosed
results, including data from the KONFIDENT phase 3 clinical trial
and ongoing KONFIDENT-S open label extension trial. Sebetralstat
met the primary endpoint for its phase 3 trial with both 300 mg and
600 mg formulations achieving the beginning of symptom relief
significantly faster than placebo (p<0.0001 for 300 mg, p=0.0013
for 600 mg) and was well-tolerated, with a safety profile similar
to placebo. In KONFIDENT-S, sebetralstat has enabled patients to
treat attacks early with a median time from attack onset to
treatment of 9 minutes, demonstrated a consistent safety and
efficacy profile with KONFIDENT, and included a median time to
beginning of symptom relief for laryngeal attacks of 1.3 hours.
KONFIDENT and KONFIDENT-S are the only clinical trials ever
conducted in HAE that instruct participants to treat their attacks
as early as possible, regardless of severity, in accordance with
on-demand treatment guidelines. Early treatment of attacks, prior
to progression, is a critical element in proper management of HAE,
to minimize symptom burden.
KalVista’s KONFIDENT-KID clinical trial, designed to evaluate
the safety and efficacy of sebetralstat in a pediatric population
aged 2-11 years, began dosing patients ahead of schedule in June
2024.
About the KONFIDENT Phase 3 Trial
The KONFIDENT phase 3 clinical trial was a randomized, double
blind, 3-way crossover trial evaluating the safety and efficacy of
sebetralstat 300 mg and 600 mg versus placebo for the on-demand
treatment of HAE in adult and pediatric patients aged 12 years and
older. The trial randomized a total of 136 HAE patients from 66
clinical sites across 20 countries, making it the largest clinical
trial ever conducted in HAE. In the trial, participants treated
each eligible attack with up to two doses of study drug and treated
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
documented HAE attacks in 90 days prior to randomization, including
patients receiving long-term prophylaxis.
About the KONFIDENT-S Trial
KONFIDENT-S is an open label extension trial with numerous
real-world elements evaluating the long-term safety and efficacy of
sebetralstat for on-demand treatment of HAE attacks in adults and
pediatric patients aged 12 years and older with HAE Type I or Type
II. KalVista plans to transition ongoing participants in the trial
to an oral disintegrating tablet (ODT) formulation in Q4 2024 to
support a planned 2026 sNDA filing of this additional formulation.
If approved, the ODT formulation would provide people living with
HAE an alternative, novel option for oral, on-demand treatment.
About the KONFIDENT-KID Trial
KONFIDENT-KID is an open label trial enrolling approximately 24
children aged 2 to 11 years across seven countries in North
America, Europe, and Asia. KONFIDENT-KID will collect safety,
pharmacokinetic, and efficacy data for each patient for up to one
year and will feature a proprietary pediatric oral disintegrating
tablet (ODT) formulation of sebetralstat. If approved, sebetralstat
would be the first oral on-demand therapy for this age group, and
only the second FDA-approved on-demand therapy of any type for this
population.
About Sebetralstat
Discovered and developed entirely by the scientific team at
KalVista, sebetralstat is a novel, investigational 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 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 global pharmaceutical
company that seeks to develop and deliver oral medicines for
diseases with significant unmet need. The Company is focused on
understanding the needs of patients and the limitations of current
therapies to design treatments that empower people to better manage
their disease and improve their lives. In August 2024, the Company
announced its NDA for sebetralstat for hereditary angioedema (HAE)
was accepted by the U.S. FDA with a PDUFA goal date of June 17,
2025. In addition, KalVista received validation of its MAA for HAE
from the EMA and has submitted MAA applications to regulators in
the United Kingdom, Switzerland, Australia, and Singapore.
For more information about KalVista, please visit
www.kalvista.com or follow on social media at
@KalVista and LinkedIn.
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
KONFIDENT-S and KONFIDENT-KID trials, 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, 2024, 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/20240930529468/en/
Media: Jenn Snyder Vice President, Corporate Affairs
(857) 356-0479 jennifer.snyder@kalvista.com
Investors: Ryan Baker Head, Investor Relations (617)
771-5001 ryan.baker@kalvista.com
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