KalVista Initiates KONFIDENT-KID Trial for On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Children Aged 2 to 11
27 Junio 2024 - 5:30AM
Business Wire
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
the initiation of the open-label KONFIDENT-KID clinical trial of
sebetralstat, a novel, oral, plasma kallikrein inhibitor, in
pediatric patients with hereditary angioedema (HAE). The trial will
enroll 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.
“We are pleased to announce that the KONFIDENT-KID trial has
started earlier than previously anticipated,” said Ben Palleiko,
Chief Executive Officer of KalVista. “This timeline reflects the
high level of excitement among physicians, caregivers, and our
patient advocacy partners regarding the potential of sebetralstat
to treat children with HAE. Currently, the only approved on-demand
treatment for this population is administered intravenously, making
this a critical area of unmet need for people living with HAE.”
If approved, sebetralstat would be the first oral on-demand
therapy in pediatric patients aged 2 – 11 years, and only the
second FDA-approved on-demand therapy of any type in this
population.
For more information on KONFIDENT-KID, please visit our listing
on clinicaltrials.gov.
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 disclosed
positive phase 3 data for the KONFIDENT trial for its oral,
on-demand therapy sebetralstat in February 2024 and submitted an
NDA with the FDA in June 2024. KalVista expects to file for
approval in the UK, Europe, and Japan 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 or other international
regulatory agencies, our expectations about safety and efficacy of
our product candidates, our ability to obtain regulatory approvals
for sebetralstat and other candidates in development within our
expected timelines or at all, our success in engaging with
potential commercial partners, the success of any efforts to
commercialize sebetralstat, the ability of sebetralstat and other
candidates in development to treat HAE or other diseases, our
ability to commence pediatric trials of sebetralstat and develop an
ODT formulation, the future progress and potential success of our
oral Factor XIIa program, our ability to reduce spending on
discovery and preclinical activities, and our expectation to become
cash flow positive. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240627071012/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)
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