KalVista Pharmaceuticals Presents Sebetralstat Data at Bradykinin Symposium 2024
September 06 2024 - 6:30AM
Business Wire
–Patient perspectives shed additional light on
the challenges of treating hereditary angioedema attacks with
injectable on-demand therapies–
–New analyses of sebetralstat clinical trials
bolster efficacy and safety profile –
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
that it presented additional analyses of the efficacy and safety of
sebetralstat from phase 2 and phase 3 double-blind,
placebo-controlled crossover clinical trials as well as interim
data from KONFIDENT-S, a phase 3 open-label extension trial, and
real-world patient data at the Bradykinin Symposium 2024 taking
place in Berlin, Germany, on September 5-6. Sebetralstat is a
novel, investigational oral plasma kallikrein inhibitor for the
on-demand treatment of hereditary angioedema (HAE) attacks in adult
and pediatric patients aged 12 years and older.
“Delay or denial in the treatment of HAE attacks is often
related to the administration of the currently approved injectable
on-demand treatments which commonly result in injection-site
reactions or pain. The data presented today highlight that oral
sebetralstat may remove these challenges and has a safety profile
no different than placebo,” said Emel Ayg�ren-Pürsün, MD,
specialist in internal medicine at the Division of Oncology,
Hematology and Hemostaseology at the Department for Children and
Adolescents of the University Hospital Frankfurt, and a leading
investigator for the phase 2, phase 3 KONFIDENT and KONFIDENT-S
trials. “Sebetralstat also resulted in rapid symptom relief in the
clinical trials. If approved, sebetralstat might become a major
advance for people living with HAE by addressing critical gaps in
the current standard of care for on-demand treatment of
attacks.”
“We are encouraged by the observation of exceptional consistency
of both safety and efficacy across the entire clinical program for
sebetralstat for the on-demand treatment of HAE,” said Paul Audhya,
MD, MBA, Chief Medical Officer of KalVista Pharmaceuticals. “These
data reinforce the potential for sebetralstat to transform the
management of HAE.”
The presentations at Bradykinin Symposium 2024 included:
- Delayed On-demand Treatment of Hereditary Angioedema Attacks
and Associated Barriers Reported by Italian patients: Mauro
Cancian, Azienda Ospedaliera, Università degli Studi di Padova,
Padova, Italy (Oral presentation)
- Many patients did not meet guideline recommendations for early
on-demand treatment following attack recognition, which resulted in
more severe attacks.
- Pooled Sebetralstat Placebo-controlled Efficacy for
On-demand Treatment of Hereditary Angioedema: Emel
Ayg�ren-Pürsün, University Hospital Frankfurt, Goethe University
Frankfurt, Germany (Poster presentation)
- Pooled analysis of a larger number of HAE attacks corroborates
the efficacy of sebetralstat for on-demand treatment, offering an
oral administration route to potentially enable early treatment and
rapid symptom relief.
- Pooled Sebetralstat Placebo-controlled Safety for On-demand
Treatment of Hereditary Angioedema: Emel Ayg�ren-Pürsün,
University Hospital Frankfurt, Goethe University Frankfurt, Germany
(Oral presentation)
- In the pooled safety analysis in phase 2 and phase 3
double-blind, placebo-controlled crossover trials, sebetralstat was
well-tolerated with a safety profile no different than
placebo.
- KONFIDENT-S Interim Analysis: Sebetralstat for Hereditary
Angioedema Attacks Including Laryngeal: Henriette Farkas,
Hungarian Angioedema Center of Reference and Excellence, Semmelweis
University, Budapest, Hungary (Oral presentation)
- Among 640 attacks treated, median time to treatment was 9
minutes for all attacks and 8 minutes for laryngeal attacks; the
median time to beginning of symptom relief was 1.8 hours for all
attacks and 1.3 hours for laryngeal attacks.
- Phase 3 KONFIDENT Trial of Sebetralstat for HAE: European
Subgroup: Andrea Zanichelli, Operative Unit of Medicine,
Angioedema Center, IRCCS Policlinico San Donato, San Donato
Milanese, Milan, Italy; Department of Biomedical Sciences for
Health, University of Milan, Milan, Italy (Poster presentation)
- In the KONFIDENT phase 3 clinical trial, the positive efficacy
and safety of sebetralstat as an on-demand treatment for HAE was
consistent between European participants and the overall
cohort.
- A specific, sensitivity assay measuring patient sample
plasma kallikrein activity: Daniel Lee, KalVista
Pharmaceuticals (Oral presentation)
- Measuring specific plasma kallikrein activity could be useful
as a biomarker for normal C1INH, which currently has no
standardized diagnostic pathway.
Links to all posters and presentations can be found on the
KalVista website under Publications.
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 for HAE in February 2024. The Company’s NDA for
sebetralstat has been accepted by the FDA with a PDUFA goal date of
June 17, 2025. In addition, KalVista received validation of its MAA
from the EMA in August 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 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/20240906021663/en/
Jenn Snyder Vice President, Corporate Affairs (617) 448-0281
jsnyder@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Aug 2024 to Sep 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Sep 2023 to Sep 2024