KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
that the European Medicines Agency (EMA) has validated the
submission of a Marketing Authorization Application (MAA) for
sebetralstat, a novel, investigational oral plasma kallikrein
inhibitor for the on-demand treatment of hereditary angioedema
(HAE). This application will now be reviewed by the EMA’s Committee
for Medicinal Products for Human Use (CHMP) under the centralized
licensing procedure for all 27 Member States of the European Union,
as well as the EEA countries Norway, Iceland and Liechtenstein.
“The validation of this MAA, which we submitted in July, brings
us another step closer to our goal of delivering sebetralstat on a
global scale to people living with HAE,” said Ben Palleiko, Chief
Executive Officer of KalVista. “If approved, sebetralstat would be
the first oral, on-demand treatment for HAE in Europe. We believe
it has the potential to become the foundational treatment for this
disease, addressing many underlying unmet needs in the
community.”
The MAA submission was 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 enabled patients to treat
attacks earlier with a median time from attack onset to treatment
of 9 minutes and a consistent safety and efficacy profile including
a median time to beginning of symptom relief for laryngeal attacks
of 1.3 hours.
Detailed data from KONFIDENT were recently published in The New
England Journal of Medicine. Data from KONFIDENT and KONFIDENT-S
were also presented at the European Academy of Allergy and Clinical
Immunology Congress 2024. In June 2024, KalVista submitted a New
Drug Application (NDA) for sebetralstat to the U.S. Food & Drug
Administration.
KalVista intends to present EU data from the KONFIDENT trial, as
well as additional data from KONFIDENT-S, at the 7th Bradykinin
Symposium on September 4-6, 2024 in Berlin, Germany.
KalVista also recently announced initiation of the KONFIDENT-KID
clinical trial, to evaluate the safety and efficacy of sebetralstat
in a pediatric population aged 2-11 years.
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 adult
patients 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 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 global pharmaceutical
company focused on the development and delivery of oral medicines
for diseases with significant unmet need. KalVista announced
positive phase 3 data from the KONFIDENT trial for its oral,
on-demand therapy sebetralstat in February 2024, and submitted an
NDA to the FDA in June 2024 and an MAA to the EMA in July 2024.
KalVista expects to file for approval in the UK, Japan, and other
countries later in 2024.
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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240815998817/en/
KalVista Pharmaceuticals, Inc. Jenn Snyder VP, Corporate
Affairs (617) 448-0281 jsnyder@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
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