KalVista Pharmaceuticals Presents Data at Eastern Allergy Conference 2024 and the Japanese Dermatological Association 2024
06 Junho 2024 - 7:30AM
Business Wire
– US subgroup in the phase 3 KONFIDENT trial
demonstrates median time to treatment of 38 minutes and time to
beginning of symptom relief 1.3 hours –
– Despite growing use of long-term prophylaxis
therapies in the US on-demand treatment prescription volumes stay
stable and non-prescription healthcare costs for management of HAE
remain substantial –
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
that it presented the US subgroup analysis from the sebetralstat
phase 3 KONFIDENT trial and real-world claims and patient survey
data at the Eastern Allergy Conference (EAC) 2024, as well as the
Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the
Japanese Dermatological Association (JDA) 2024. KONFIDENT is the
first pivotal phase 3 trial to include Japanese sites in an HAE
development program.
The following presentations occurred at EAC 2024:
- Sebetralstat for On-demand Treatment of Hereditary
Angioedema Attacks: US Subgroup Analysis from the Double-blind,
Placebo-controlled Phase 3 KONFIDENT Trial: Daniel Soteres,
Asthma & Allergy Associates P.C., Colorado Springs, Colorado,
United States. (Poster presentation)
- Median time from attack onset to administration was 38 minutes
(IQR 5-124) for the US subgroup (78 attacks), which compares
favorably to the median time to treatment of 41 minutes (IQR 6-140)
in the overall trial population
- Median time to beginning of symptom relief for 300 mg in the US
subgroup was 1.28 hours (IQR 0.77-3.12), which also compares
favorably to the 300 mg median time to beginning of symptom relief
of 1.61 hours (IQR 0.78-7.04) for the overall trial population
- Trends in volume of on-demand hereditary angioedema
treatments in the US: A retrospective analysis of a large
multi-payer claims database: Daniel Soteres, Asthma &
Allergy Associates P.C., Colorado Springs, Colorado, United States.
(Poster presentation)
- Despite the advent of multiple non-androgen LTPs since 2017,
the overall trend in the total number of claims reimbursed and
quantity dispensed for on-demand treatments has remained stable in
the US
- Average year-over-year variability in the total number of
on-demand syringes and vials dispensed per quarter has remained
within 3% and 10%, respectively, of baseline from Q3 2018 – Q3
2023
- Healthcare Costs Among Commercially Insured Patients with
Hereditary Angioedema Managed with Long-term Prophylaxis: a
Retrospective US Claims Database Analysis: Daniel Soteres,
Asthma & Allergy Associates P.C., Colorado Springs, Colorado,
United States. (Poster presentation)
- Claims database analysis revealed that HAE-related non-pharmacy
resource utilization costs among patients receiving non-androgen
LTP were substantial, averaging >$641,000 in HAE healthcare
costs per patient per year
- Approximately one-third of patients receiving non-androgen LTP
had ≥1 HAE-related ER visits during follow-up (33%), and nearly
one-quarter (22%) had ≥1 HAE-related home health visit
- Real-World Impact of Treated Hereditary Angioedema Attacks
on Patients’ Quality of Life: Maeve O’Connor, Allergy, Asthma,
& Immunology Relief of Charlotte, Charlotte, NC, United States.
(Poster presentation)
- Attacks occurring among patients receiving non-androgen LTP and
those receiving on-demand treatment only similarly impact physical
and social quality of life (QoL)
- Attacks treated in <1 hour were associated with a lower
impact on QoL
- Real-world Impact of Treated Hereditary Angioedema Attacks
on Patients’ Employment and Work Productivity: Maeve O’Connor,
Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte,
NC, United States. (Poster presentation)
- HAE attacks among patients receiving non-androgen LTP and those
receiving on-demand treatment only similarly impacted the work
lives of employed patients resulting in impairments in their
ability to work, substantial absenteeism, reduced productivity, and
presenteeism among those who were able to work
- Burden of the Untreated Attacks and its Impact on Social,
Mental and Physical Health: Maeve O’Connor, Allergy, Asthma,
& Immunology Relief of Charlotte, Charlotte, NC, United States.
(Poster presentation)
- Patients, including those taking LTP, reported that untreated
HAE attacks often progressed in severity, migrated to other
locations, and were associated with social isolation and impact on
physical/mental health
- 70% of patients indicated that their last untreated attack had
an impact on their energy levels; 55% and 22% of LTP and on-demand
only patients, respectively, felt reluctant to go out in
public
The following presentation occurred at the Annual Meeting of the
JDA 2024:
- Sebetralstat KONFIDENT Is the First Phase 3 On-demand HAE
Trial to Include Japanese Sites: Daisuke Honda, Chiba
University Graduate School of Medicine, Chiba, Japan. (Poster
presentation)
- Despite the relatively small number of attacks that were
treated in the subgroup of Japanese KONFIDENT participants, primary
endpoint results were consistent with those observed in the overall
trial population
- Among Japanese participants, sebetralstat was well tolerated
with no treatment-related TEAEs, no serious or severe TEAEs, and no
TEAEs leading to study discontinuation
“We have observed exceptional consistency of results across
subgroups in the KONFIDENT trial including attack severity,
location, treatment paradigm (with or without long-term
prophylaxis) and geography,” said Ben Palleiko, CEO of KalVista
Pharmaceuticals. “This data further highlights that patients on LTP
generally continue to have attacks, and that those attacks have
similar impact as on-demand only users, showing the continued unmet
need although it is not generally recognized. In parallel, claims
data also highlight that on-demand prescription volumes have
remained stable despite the introduction of subcutaneous and oral
long-term prophylaxis options. Sebetralstat has the potential to
transform the management of HAE.”
Links to all posters and presentations can be found on the
KalVista website under “Publications”.
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 disclosed
positive phase 3 data for the KONFIDENT trial for its oral,
on-demand therapy sebetralstat in February 2024. The Company
anticipates submitting a new drug application to the U.S. Food and
Drug Administration (FDA) for sebetralstat in June 2024 and expects
to file for approval in the UK, Europe and Japan later in 2024.
For more information about KalVista, please visit
www.kalvista.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 or other international
regulatory agencies, our expectations about safety and efficacy of
our product candidates, our ability to obtain regulatory approvals
for sebetralstat and other candidates in development within our
expected timelines or at all, our success in engaging with
potential commercial partners, the success of any efforts to
commercialize sebetralstat, the ability of sebetralstat and other
candidates in development to treat HAE or other diseases, our
ability to commence pediatric trials of sebetralstat and develop an
ODT formulation, the future progress and potential success of our
oral Factor XIIa program, our ability to reduce spending on
discovery and preclinical activities, and our expectation to become
cash flow positive. 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, 2023, 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/20240606656084/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice
President, Corporate Communications (201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
KalVista Pharmaceuticals (NASDAQ:KALV)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024