KalVista Pharmaceuticals Awarded UK Promising Innovative Medicine (PIM) Designation for Sebetralstat
March 12 2024 - 6:30AM
Business Wire
– Full EAMS designation would allow treatment
of patients with sebetralstat prior to receiving a Marketing
Authorization from UK –
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 Promising Innovative Medicine (PIM)
designation for sebetralstat, an investigational novel, oral plasma
kallikrein inhibitor for the on-demand treatment of hereditary
angioedema (HAE). The PIM is the first step in the Early Access to
Medicines Scheme (EAMS) which would allow KalVista to treat
patients with sebetralstat prior to receiving a Marketing
Authorisation.
“We are proud to have sebetralstat designated as a Promising
Innovative Medicine by the MHRA, which is similar to Expanded
Access in the US,” said Ben Palleiko, Chief Executive Officer of
KalVista. “Receiving the PIM designation shows that the MHRA
believes that we have a promising candidate for the EAMS to treat
people living with HAE.”
The PIM designation also gives companies the opportunity to have
early in-depth discussions with both the National Health Service
(NHS) and the UK’s Health Technology Agencies.
KalVista recently provided phase 3 data for sebetralstat at the
American Academy of Allergy, Asthma & Immunology (AAAAI) Annual
Meeting, which displayed clinically and statistically significant
results across all endpoints, and an excellent safety and
tolerability profile.
About the Promising Innovative Medicine Designation
A Promising Innovative Medicine Designation is an early
indication that a medicinal product is a promising candidate for
the Early Access to Medicines Scheme (EAMS), intended for the
treatment, diagnosis or prevention of a life-threatening or
seriously debilitating condition with the potential to address an
unmet medical need. The designation is issued after an MHRA
scientific designation meeting on the basis of non-clinical and
clinical data available on the product, in a defined disease area.
Following designation, the applicant is expected to complete a
clinical development program within a reasonable time period, in
order to continue with an application under the EAMS (step II). A
designation is a prerequisite to enter the EAMS scientific opinion
assessment step.
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 their results, our ability 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240312355965/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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