KalVista Pharmaceuticals Presents Data on Persisting Unmet Needs in Hereditary Angioedema at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024
03 June 2024 - 8:30PM
Business Wire
– Patient perspectives reveal the challenges of
injecting on-demand therapies and the consequences of delayed or
withheld treatment -
– Physicians characterize breakthrough HAE
attacks occurring in patients receiving non-androgen long-term
prophylaxis -
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced
that it presented real-world data from US patient surveys that
assessed the experience of HAE patients using injectable on-demand
treatments at the European Academy of Allergy and Clinical
Immunology Congress 2024 that took place in Valencia, Spain.
The following presentations occurred at EAACI 2024:
- Hereditary Angioedema (HAE) Patients Answer: Why Do Attacks
Go Untreated? Cristine Radojicic, Division of Pulmonary,
Allergy and Critical Care, Duke University Medical Center, Durham,
North Carolina, USA. (Flash Talks Session)
- For 50% of US survey respondents with HAE, their untreated
attack progressed in severity while 25% of attacks migrated to
other anatomic locations including the throat
- Common reasons for not treating were desire to save injectable
on-demand treatment for a severe attack, presumption the attack
would stay mild, wanting to avoid needle pain or injection burning,
stinging, or pain, and not having on-demand treatment with
them
- Delayed On-demand Treatment of Hereditary Angioedema
Attacks: Patient Perceptions and Associated Barriers Rashmi
Jain, Consultant in Clinical Immunology, Oxford University Hospital
Trust, Oxford, UK. (Poster presentation)
- 63% of UK survey participants reported their perception of time
to treatment for HAE attacks as “early” despite only 14% treating
in less than one hour
- Common barriers to early on-demand treatment included the
belief that the attack was going to remain mild and wanting to save
injectable on-demand treatment for a severe attack
- Anxiety Associated with On-Demand Treatment for Hereditary
Angioedema Attacks Patrick Yong, Frimley Health NHS Foundation
Trust, Frimley, UK. (Poster presentation)
- Almost half of UK survey participants reported moderate to
extreme anxiety when anticipating use of injectable on-demand
therapy to treat an attack
- Top reasons for feeling anxious were desire not to ‘waste’
on-demand treatment, uncertainty about how long the treatment would
take to begin working, and finding a vein for IV infusion
- Patient-Reported Benefits of Early On-demand Treatment of
HAE Attacks Hilary Longhurst, Auckland City Hospital, Te Toka
Tumai, and University of Auckland, Auckland, New Zealand. (Poster
presentation)
- Results from this analysis highlight that survey respondents
with HAE who treat their attacks early (<1 hour) are more likely
to carry their on-demand treatment with them and treat more attacks
overall compared with those who delay treatment (90.3% vs.
72.6%)
- People living with HAE who treat their attacks early also
recover more quickly from HAE attacks (1.4 hours vs 2.9 hours for
those who waited ≥1 hour to treat), achieve full recovery earlier
(1.3 vs 1.9 days), and feel less anxious when anticipating
on-demand treatment
- Treatment of HAE Attacks with Anticipated Future Oral
On-demand Therapies as Reported by Patients Anna Valerieva,
Medical University of Sofia, Sofia, Bulgaria. (Poster presentation)
- Survey respondents reported that they anticipated carrying an
oral on-demand treatment 95.1% of the time compared with 63.9% with
parenteral on-demand treatment; they would treat 88.5% of their
attacks with an oral on-demand treatment compared with 80.3% with
parenteral on-demand treatment
- Of the respondents who thought they would treat attacks earlier
with a pill vs. an injectable, 80% reported that they would have
less anxiety when anticipating using an oral on-demand
treatment
- Attack Characteristics in Patients with Hereditary
Angioedema Receiving Non-Androgen Long-term Prophylaxis
William Lumry, Allergy and Asthma Research Associates, Dallas,
Texas, United States. (Flash Talks session)
- In patients using non-androgen LTP, 68% of patients reported
their most recent attack as moderate to very severe; 19.6% of these
attacks involved laryngeal swelling and 12% required an ER visit or
hospitalization
- Only 55% of patients reported all their attacks to their
physicians, which may have resulted in underestimation of attacks
while receiving non-androgen LTP
- Unmet Needs Associated with Non-androgen Long-term
Prophylaxis (LTP) Therapies for HAE William Lumry, Allergy and
Asthma Research Associates, Dallas, Texas, United States. (Poster
presentation)
- Despite the availability of non-androgen LTPs, their use is
associated with a high treatment burden
- Lack of efficacy and gastrointestinal issues were the most
common issues reported by physicians for patients using oral LTP;
route of administration, discomfort, and frequent dosing schedule
were the most common issues reported by physicians for patients
using injectable LTPs
- A Sensitive and Specific Assay to Characterize Plasma
Kallikrein Activity in Plasma from Hereditary Angioedema (HAE)
Patients: Daniel Lee, KalVista Pharmaceuticals Inc., Cambridge,
MA, USA. (Oral Abstract Session)
- Outlines substantial progress on a sensitive and specific PKa
assay that could be useful to characterize the level of PKa
activity in plasma samples from PKa-mediated diseases, including
patients diagnosed with HAE with normal C1 esterase inhibitor
(nC1-INH-HAE)
“There is a consensus that the ultimate goals of treatment in
HAE are to achieve total control of the disease and to normalize
patients’ lives. Despite the availability of numerous treatments
for HAE, there remains far greater unmet need than is generally
perceived, including among patients receiving non-androgen
prophylactic treatments,” said Ben Palleiko, Chief Executive
Officer of KalVista. “Whether related to treatment burden,
inadequate efficacy, or side effects, a new treatment paradigm is
needed to optimize the management of people living with HAE. Based
on the recently presented and published phase 3 KONFIDENT results,
we believe that oral sebetralstat has the potential to change the
treatment landscape.”
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240603431601/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
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