KalVista Pharmaceuticals Provides Progress Updates on Sebetralstat Development
14 February 2023 - 10:30PM
Business Wire
- Phase 3 KONFIDENT clinical trial passes 50%
enrollment milestone -
- Topline data still expected in H2 2023 -
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage
pharmaceutical company focused on the discovery, development, and
commercialization of oral, small molecule protease inhibitors,
today provided multiple clinical trial and regulatory updates for
its lead compound sebetralstat, as a potential oral on-demand
therapy for HAE attacks.
Clinical Trial and Regulatory Updates:
- KalVista has enrolled more than 50% of the 114 targeted number
of patients in the pivotal phase 3 KONFIDENT clinical trial. The
trial will conclude once 84 of the patients enrolled complete the
three-attack treatment sequence. As per previous guidance, topline
data for the trial remains expected in the second half of
2023.
- KONFIDENT is currently enrolling patients at more than 50
active sites in 17 countries, and the KONFIDENT-S open label
extension study also continues to enroll in accordance with
plan.
- The Company recently received additional FDA regulatory
guidance for the oral disintegrating tablet (ODT) formulation of
sebetralstat that confirmed the requirements to support a
supplemental NDA (sNDA) filing. The guidance from FDA included that
no efficacy trials with the ODT formulation will be required prior
to filing the supplemental NDA (sNDA) filing. KalVista anticipates
that the ODT formulation will follow the expected initial launch
formulation in the US and EU, although it may become the initial
launch formulation in other geographies.
- KalVista also recently received guidance from the Japanese
regulatory authority (PMDA) on the clinical development pathway to
a regulatory submission in that country. KalVista will now be
enrolling Japanese patients in both KONFIDENT and KONFIDENT-S to
support the filing, and clinical sites for Japanese enrollment have
been selected and start up activities are underway.
“We are very pleased with the recent progress of the
sebetralstat development program,” said Andrew Crockett, Chief
Executive Officer of KalVista. “We have already exceeded our
recruitment target goals for KONFIDENT in the US, and recruitment
outside the US continues to accelerate as new sites come online. We
continue to believe that sebetralstat can fill an important unmet
need for efficacious and safe oral, on-demand therapy, and we
expect to be the first to provide this important therapeutic
advance to people living with HAE.”
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 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 the treatment for people living with HAE and other
diseases.
For more information about KalVista, please visit
www.kalvista.com.
For more information on the sebetralstat HAE on-demand Phase 3
KONFIDENT study, 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 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 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, 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/20230214005142/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice
President, Corporate Communications (201) 705-0254
jarrod.aldom@kalvista.com
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