KalVista Pharmaceuticals Awarded UK Innovation Passport for Sebetralstat
February 20 2024 - 5:30AM
Business Wire
– Provides entry to UK Innovative Licensing and
Access Pathway (ILAP), which aims to accelerate time to market and
facilitate patient access to innovative medicines –
– Late-breaking sebetralstat phase 3 data to be
presented at the upcoming 2024 American Academy of Allergy, Asthma
& Immunology Annual Meeting –
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 the UK Medicines and Healthcare products Regulatory
Agency (MHRA) has awarded the Innovation Passport for sebetralstat,
an investigational novel, oral plasma kallikrein inhibitor for the
on-demand treatment of hereditary angioedema (HAE). The Innovation
Passport is the first step in the UK’s Innovative Licensing and
Access Pathway (ILAP), which is designed to accelerate a product’s
time to market and facilitate patient access to innovative
medicines.
“As a company which has its roots in the UK, we are pleased to
receive the ILAP designation, which will enable us to further
accelerate our regulatory submission for sebetralstat,” said Andrew
Crockett, Chief Executive Officer of KalVista. “We look forward to
collaborating with the MHRA and other health regulatory agencies
worldwide as we continue to work towards bringing the first oral,
on demand treatment to people living with HAE.”
KalVista recently provided topline phase 3 data for
sebetralstat, which displayed clinically and statistically
significant results across all endpoints, and an excellent safety
and tolerability profile. The Company will be presenting
late-breaking KONFIDENT trial data on February 25, 2024, at the
upcoming American Academy of Allergy, Asthma & Immunology
(AAAAI) Annual Meeting.
About the Innovation Passport
Delivered in partnership by the All Wales Therapeutics and
Toxicology Centre (AWTTC), the Medicines and Healthcare products
Regulatory Agency (MHRA), the National Institute for Health and
Care Excellence (NICE) and the Scottish Medicines Consortium (SMC),
the Innovation Passport prioritizes innovative medicines in
development for the treatment of diseases for patients with
significant unmet need. Benefits of the ILAP include opportunities
for enhanced regulatory and other stakeholder access with the aim
of accelerating the time it takes for a product to reach the
market, thereby boosting patients’ access to innovative
medicines.
About Sebetralstat
Discovered by KalVista, sebetralstat is an investigational
novel, oral plasma kallikrein inhibitor for the on-demand treatment
of hereditary angioedema (HAE). Sebetralstat has 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 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/20240220763544/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 Apr 2024 to May 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From May 2023 to May 2024