KalVista Pharmaceuticals Announces Termination of KVD824 Phase 2 KOMPLETE Trial for Prophylactic Treatment of Hereditary Angioedema
October 04 2022 - 6:30AM
Business Wire
- Safety signals observed will not yield
targeted product profile –
- No impact on Sebetralstat expected safety
profile or Phase 3 KONFIDENT trial –
- Oral Factor XIIa program to become primary
focus for HAE prophylaxis -
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 that it has terminated the KOMPLETE phase 2
clinical trial for KVD824 for the prevention of attacks in people
with hereditary angioedema (HAE). This decision was based on the
observation of liver enzyme (ALT/AST) elevations in multiple
patients in all treatment groups of the trial. No patients had
concomitant elevation of bilirubin levels and all were
asymptomatic.
“The health and safety of participants in our clinical trials is
of utmost importance to us,” said Andrew Crockett, Chief Executive
Officer of KalVista. “We made the difficult decision to terminate
KOMPLETE because we concluded that the emerging safety profile of
the current formulation will not meet our requirements for a
best-in-class oral prophylactic therapy. This termination conserves
our financial resources and allows us to focus on continuing to
advance sebetralstat through the ongoing phase 3 program and
towards a planned 2024 NDA filing, as well as on our emerging oral
Factor XIIa inhibitor program as a potential once daily
prophylactic therapy for people with HAE.”
The KOMPLETE trial is a phase 2 clinical trial evaluating
KVD824, an investigational oral plasma kallikrein inhibitor
designed for the prevention of attacks in adults living with HAE.
Patients in the trial were randomized to one of three treatment
groups, each placebo controlled: 300 mg, 600 mg, 900 mg KVD824 (or
placebo), all dosed twice daily. A total of 33 patients were
enrolled in the trial, of which 7 patients experienced either Grade
3 or Grade 4 elevations of liver enzymes at timeframes ranging from
two to twelve weeks. The elevations were noted in all treatment
groups. One additional Grade 4 elevation was recorded in a patient
at the baseline visit, prior to receiving study drug. KalVista will
proceed to finalize the database of the trial and assess the
unblinded data for efficacy and safety to determine the potential
for any further development.
KalVista continues to recruit the phase 3 KONFIDENT trial
assessing sebetralstat (formerly KVD900) as a potential oral,
on-demand therapy for HAE attacks, with data anticipated in the
second half of 2023. Sebetralstat is a distinct compound from
KVD824, and no treatment related liver enzyme elevations in
patients have been observed in any sebetralstat clinical studies,
including in the ongoing Phase 3 KONFIDENT trial.
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 has developed a proprietary
portfolio of novel, small molecule plasma kallikrein inhibitors
initially targeting hereditary angioedema (HAE) and diabetic
macular edema (DME). KalVista is developing sebetralstat as an oral
on-demand therapy for HAE attacks and is enrolling the Phase 3
KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa
inhibitor program represents a new generation of therapies that may
further improve treatment for people living with HAE. In DME, an
intravitreally administered plasma kallikrein inhibitor, called
KVD001, has completed a Phase 2 clinical trial.
For more information about KalVista, please visit
www.kalvista.com.
For more information on the sebetralstat HAE on-demand Phase 3
KONFIDENT trial, please visit www.konfidentstudy.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, including the
potential impact of COVID-19, 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 Phase 3 KONFIDENT
trial, and to obtain regulatory approvals for sebetralstat and
other candidates in development, the ability of sebetralstat and
other candidates in development to treat HAE or DME, 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, 2022, 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/20221004005432/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice
President, Corporate Communications (201) 705-0254
jarrod.aldom@kalvista.com
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