–New data show effectiveness of sebetralstat in
reducing anxiety during attacks; supports need for oral on-demand
option to treat attacks earlier and more often–
–Patient perspectives spotlight the prevalence
of anxiety when faced with administering injectable on-demand
therapies–
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
that it presented data showing the effectiveness of sebetralstat in
reducing anxiety among people experiencing hereditary angioedema
(HAE) attacks at the HAEi Global Angioedema Forum (GAF) taking
place in Copenhagen, Denmark, October 4 - 5, 2024. These data were
generated in the KONFIDENT phase 3 clinical trial, for which the
Company disclosed top line results in February 2024. Sebetralstat
is a novel, investigational oral plasma kallikrein inhibitor for
the on-demand treatment of HAE attacks in adults and adolescents
aged 12 years and older.
KONFIDENT was the first randomized controlled trial to assess
the impact of an on-demand treatment on anxiety associated with HAE
attacks. This prespecified exploratory analysis was presented by
Dr. William R. Lumry, AARA Research Center, Dallas, TX, USA and
investigated attack-associated anxiety (in the absence of
injectable therapy) in the phase 3 KONFIDENT trial and the impact
of sebetralstat on anxiety, compared with placebo. Participants
self-reported anxiety using a Modified Generalized Anxiety Numeric
Rating Scale. Overall, anxiety was reduced among patients treated
with sebetralstat 300mg (P=0.004 and P=0.022, respectively) and
600mg (P=0.0008 and P=0.0012) versus placebo. For participants with
moderate-to-extreme anxiety, change from baseline at 4 hours was
−2.8 (−3.6, −1.9) for each sebetralstat group and −1.3 (−2.2, −0.4)
for placebo and at 12 hours was −3.5 (−4.3, −2.6) with sebetralstat
300mg, −4.3 (−5.2, −3.5) with 600mg, and −1.7 (−2.6, −0.8) with
placebo. Notably, anxiety reduction was correlated with earlier
time to beginning of symptom relief.
“The data presented at the Global Angioedema Forum highlights
that people living with HAE often experience substantial anxiety
when they have attacks, which reduces quality of life. In
KONFIDENT, oral sebetralstat significantly reduced anxiety during
attacks compared with placebo, especially among participants with
moderate-to-extreme anxiety,” said William Lumry, M.D., Allergy and
Asthma Research Associates, Dallas, Texas, United States. “If
approved, sebetralstat has the potential to become an important
option for people living with HAE who experience attack-related
anxiety, enabling them to treat early and recover from their
attacks sooner.”
Additional poster presentations at the HAEi Global Angioedema
Forum 2024:
- Anxiety Associated with Parenteral On-Demand Treatment for
Hereditary Angioedema Attacks: Riccardo Senter, Azienda
Ospedaliera, Università degli Studi di Padova, Padova, Italy
- A substantial proportion of survey respondents experienced
moderate to extreme anxiety due to anticipated use of on-demand
treatment, particularly adolescents and those previously diagnosed
with anxiety.
- Reasons for anxiety were most commonly related to treatment
effectiveness, administration burden/side effects, and
cost/access.
- Effective alternatives to current parenteral on-demand
treatments are needed to address treatment-related anxiety
associated with HAE attacks.
- The Hereditary Angioedema (HAE) Attack Journey: A Conceptual
Model of Patient Anxiety and On-Demand Treatment Burden During an
HAE Attack: Douglas Jones, Metrodora Institute, Salt Lake City,
Utah
- The survey highlighted that people living with HAE experience
anxiety when anticipating parenteral on-demand treatment.
- People with HAE often delay administering on-demand treatment
with longer treatment delays reported by those feeling moderately
to extremely anxious.
- Participants expressed that anxiety decreased once they began
to recover from their attacks.
- Impact of Delayed Treatment of Hereditary Angioedema Attacks
on Quality of Life and Ability to Work: Patrick Yong, Frimley
Health NHS Foundation Trust, Frimley, United Kingdom
- Nearly all participants waited an hour or longer to treat their
attacks and reported quality of life and work productivity were
worse.
- Findings highlight the need for more education on treating at
the earliest recognition of an attack and addressing barriers that
contribute to treatment delays.
- Impact of Hereditary Angioedema Attacks on Quality of Life
and Ability to Work Among UK Patients Receiving Long-term
Prophylaxis or On-demand Treatment Only: Patrick Yong, Frimley
Health NHS Foundation Trust, Frimley, United Kingdom
- More than half of the total respondents were receiving
long-term prophylaxis at the time of their most treated
attack.
- 87% of respondents considered their attacks moderately severe
to very severe.
- Those receiving parental on-demand treatment only and those
receiving parental on-demand treatment plus LTP experienced
substantial burden during their last treated HAE attack, in terms
of physical, mental, and social QoL, as well as work
productivity.
- Phase 3 KONFIDENT Trial of Oral Sebetralstat for Treatment
of Hereditary Angioedema Attacks: Analysis of the European and US
Patient Subgroups: 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 the European and U.S. subgroups.
- Patient-Reported Benefits of Early On-demand Treatment of
HAE Attacks: Mar Guilarte, Allergy Department, Hospital
Universitari Vall d'Hebron, Barcelona, Spain
- People living with HAE reported several positive benefits when
treating attacks early with on-demand treatment: more likely than
those who delayed treatment to carry their on-demand treatment with
them, treat more attacks, feel less anxious when anticipating
on-demand treatment, and recover more quickly from HAE
attacks.
- Treatment of HAE Attacks with Anticipated Future Oral
On-demand Therapies as Reported by Patients: Anna Valerieva
Department of Allergology, Medical University of Sofia, Sofia,
Bulgaria
- According to a survey of more than 100 participants, people
living with HAE who are using parenteral on-demand treatment may
treat more of their attacks and treat earlier with the availability
of an oral on-demand treatment option.
- In addition, respondents noted they are less likely to
experience anxiety when anticipating administration of an oral
on-demand treatment.
- Global Frequency and Diagnosis of Hereditary Angioedema with
Normal C1INH: A Real World ACARE Survey: Markus Magerl,
Angioedema Center of Reference and Excellence (ACARE), Institute of
Allergology, Charité – Universitätsmedizin Berlin, corporate member
of Freie Universität Berlin and Humboldt-Universität zu Berlin,
Berlin, Germany; Fraunhofer Institute for Translational Medicine
and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany
- Due to varying clinical approaches, there are substantial
delays in diagnosis of HAE for people with normal C1INH, which
currently has no standardized diagnostic pathway.
- There is a need for evolved and consistent approaches to
improve accurate diagnosis and clinical management of this patient
population.
Links to all posters and presentations can be found on the
KalVista website under Publications.
In Memoriam: KalVista would like to acknowledge and honor the
memory of Prof. Marcus Maurer, Professor of Dermatology and
Allergy, Executive Director of the Institute of Allergology at the
Charité – Universitätsmedizin Berlin, and Co-Director of
Allergology and Immunology at the Fraunhofer Institute for
Translational Medicine and Pharmacology ITMP. Our thoughts remain
with his family and the entire angioedema and urticaria
community.
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 that seeks
to develop and deliver oral medicines for diseases with significant
unmet need. The Company is focused on understanding the needs of
patients and the limitations of current therapies to design
treatments that empower people to better manage their disease and
improve their lives. KalVista’s NDA filing for sebetralstat for the
on-demand treatment of hereditary angioedema (HAE) attacks has been
accepted by the U.S. FDA with a PDUFA goal date of June 17, 2025.
In addition, KalVista has received validation of its MAA for HAE
from the EMA and has submitted MAA applications to regulators in
the United Kingdom, Switzerland, Australia, and Singapore.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241004668357/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
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