–Phase 3 trial data show that early treatment
is correlated with shorter attack duration–
– Rigorous comparison of Phase 3 results for
oral sebetralstat and pivotal trial results of IV recombinant
C1-inhibitor for on-demand treatment of HAE attacks shows no
differences in time to beginning of symptom relief –
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
the presentation of new sebetralstat data at the American College
of Allergy Asthma and Immunology (ACAAI) taking place in Boston, MA
from October 24 - 28, 2024.
Tim Craig, DO, Professor, Departments of Medicine and
Pediatrics, Division of Pulmonary, Allergy and Critical Care
Medicine, Penn State Health, and KONFIDENT investigator, presented
data on the Correlation of Time to Treatment with Attack
Duration in the Sebetralstat KONFIDENT Phase 3 Trial that
showed complete attack resolution was achieved faster in attacks
that were treated earlier (1st quartile) compared with those
treated later (4th quartile).
“This is the first time in a Phase 3 on-demand trial where we
can see that treating attacks within minutes versus hours has a
meaningful impact on clinical outcomes. While injectable on-demand
therapies are effective, there are numerous barriers patients face
that lead to delay or denial of HAE on-demand treatment,” said Dr.
Craig. “These data help to clarify the potential value of
sebetralstat if approved: reduced burden enabling patients to treat
attacks early and achieve earlier symptom relief and shorter attack
duration.”
William Lumry, MD, Medical Director AARA Research Center, Dallas
and KONFIDENT investigator, presented data on the Substantial
Reduction of HAE Symptom Burden in the Sebetralstat Phase 3
KONFIDENT Trial which showed that among attacks that had
progressed to at least moderate severity on the Patient Global
Impression of Severity (PGI-S) prior to treatment, those treated
with sebetralstat 300mg (n=49, P=0.002) and sebetralstat 600mg
(n=52, P=0.034) achieved a faster reduction in substantial symptom
burden (reduction in PGI-S to “mild”) than with placebo (n=46),
with median times of 5.0 hours, 5.2 hours, and >12 hours,
respectively.
“All other clinical trial designs for on-demand therapy have
required attacks to be at least moderate in severity to be eligible
to treat. This changed with the sebetralstat Phase 2 and 3 trials
which, consistent with modern HAE guidelines, instructed patients
to treat attacks early. Despite this, approximately half of attacks
progressed in severity prior to treatment,” said Dr. Lumry. “Among
these more severe attacks, which were treated somewhat later,
sebetralstat reduced symptom burden to “mild” significantly faster
than placebo, with a median time of approximately 5 hours for
sebetralstat vs >12 hours for placebo.”
The following are details for the additional ePoster - Meet the
Author data presentations at ACAAI 2024:
- Indirect Treatment Comparison of Oral Sebetralstat and
Intravenous rhC1-INH as On demand Treatments for Hereditary
Angioedema: H. Henry Li, Institute for Asthma and Allergy,
Chevy Chase, MD, USA
- The network meta-analysis (NMA) fixed effects model found no
significant differences in time to beginning of symptom relief
between sebetralstat 300mg and IV-rhC1-INH 50 IU/kg (HR [95% CI]
0.96 [0.42-2.15] to 1.19 [0.58-2.45]).
- After adjusting for baseline attack severity, matching-adjusted
indirect comparison showed numerically favorable results with
sebetralstat versus IV-rhC1-INH.
- On-demand Treatment of Laryngeal Hereditary Angioedema
Attacks with Sebetralstat: Pooled Analysis from KONFIDENT and
KONFIDENT-S: Emel Ayg�ren-Pürsün, University Hospital
Frankfurt, Goethe University Frankfurt, Frankfurt, Germany
- Pooled Analysis from KONFIDENT and KONFIDENT-S included 16
laryngeal attacks treated with sebetralstat 600mg. Median time to
treatment was 8 minutes.
- Median time to beginning of symptom relief was 1.5 hours;
median time to reduction in severity was 1.7 hours; median time to
complete attack resolution was 9.7 hours.
- Patient-Reported Anxiety Impacts Utilization of Injectable
On-demand Treatment of Hereditary Angioedema Attacks: Cristine
Radojicic, Duke University School of Medicine, Durham, NC, USA
- The survey highlighted patients with Type I/II HAE who reported
waiting 2.4 hours to treat their HAE attack after recognizing the
initial onset of the attack.
- Those who were experiencing anxiety related to their injectable
on-demand treatment were most likely to delay or not treat
attacks.
“The HAE community has long sought a less invasive treatment
option that combines needed efficacy with lower treatment burden.
These presentations continue to demonstrate that sebetralstat has
the potential to provide injectable-like efficacy in a pill,” said
Ben Palleiko, CEO of KalVista Pharmaceuticals. “If approved,
sebetralstat will be the only on-demand treatment option that will
have demonstrated the ability to enable compliance with treatment
guidelines that call for early treatment of attacks, regardless of
severity or location.”
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 whose
mission is to develop and deliver life-changing oral medicines for
people affected by rare diseases with significant unmet need.
Sebetralstat, our novel, investigational candidate for the oral,
on-demand treatment of hereditary angioedema, is under regulatory
review by the U.S. FDA with a PDUFA goal date of June 17, 2025. In
addition, we have completed marketing authorization application
(MAA) submissions for sebetralstat to the European Medicines Agency
as well as the United Kingdom, Switzerland, Australia, and
Singapore, and we anticipate filing a MAA in Japan in late 2024.
For more information, 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/20241028943529/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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