Data of Deucrictibant for the On-Demand Treatment of HAE Attacks Presented at the EAACI Congress 2023
June 10 2023 - 5:01PM
Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today announced two
presentations highlighting data from RAPIDe-1, a Phase 2 study of
PHVS416 (deucrictibant immediate-release capsules) for the
on-demand treatment of HAE attacks, included in the “Flash Talks on
Angioedema” session at the European Academy of Allergy &
Clinical Immunology (EAACI) Hybrid Congress 2023, taking place in
Hamburg, Germany, from June 9-11, 2023.
Presentation details:
- Title: Treatment with Oral Administered
Bradykinin B2 Receptor Inhibitor PHVS416 Improves Hereditary
Angioedema Attack SymptomsAbstract
Number: 001557Date/Time: Sunday,
June 11, 14:10 CEST (8:10 a.m.
EDT)Presenter: Emel Aygören-Pürsün, M.D.,
University Hospital Frankfurt
- Title: Efficacy and Safety of Oral
Administered Bradykinin B2 Receptor Inhibitor PHVS416 in Treatment
of Hereditary Angioedema Attacks: Topline Results of RAPIDe-1 Phase
2 TrialAbstract
Number: 001510Date/Time: Sunday,
June 11, 14:30 CEST (8:30 a.m.
EDT)Presenter: Marcus Maurer, M.D., Charité
Universitätsmedizin Berlin
“When asked to identify the most important factor in selecting
an on-demand therapy, both people living with HAE and their
treating physicians indicated that rapidity to onset of symptom
relief and complete symptom relief were essential,” said Wim
Souverijns, Ph.D., Chief Community Engagement and Commercial
Officer of Pharvaris. “Additionally, our research points to
multiple reasons why not all HAE attacks are treated in a timely
manner or treated at all, as is recommended by international
clinical guidelines, including fear of injection pain, anxiety
regarding the ability of a therapy to completely treat an attack
with a single dose, and lack of confidence in the speed of symptom
relief. An effective oral therapy that provides rapid and complete
symptom relief could address some of these barriers.”
“The results from the Phase 2 RAPIDe-1 clinical study show that
treatment of an HAE attack with PHVS416 (deucrictibant
immediate-release capsules) resulted in rapid and clinically
meaningful improvement in symptoms as compared to placebo,” said
Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “The
study met the primary and all key secondary endpoints, providing
evidence for the efficacy and tolerability of PHVS416 in treating
HAE attacks and supports its further development as a potential
on-demand therapy for HAE.”
The posters are available on the Investors section of the
Pharvaris website at:
https://ir.pharvaris.com/news-events/events-presentations.
About RAPIDe-1RAPIDe-1 is a Phase 2,
double-blind, placebo-controlled, randomized, cross-over,
dose-ranging trial of PHVS416 (immediate-release deucrictibant
capsules) for the treatment of HAE type 1 and type 2 (HAE-1/2)
attacks. The trial enrolled participants in Canada, Europe, Israel,
the United Kingdom, and the United States. Eligible participants
were between the ages of 18 and 75 years, diagnosed with HAE type I
or II and experienced three or more attacks in the last four months
or two or more attacks in the last two months prior to screening.
Seventy-four participants were enrolled and 62 of them experienced
147 qualifying HAE attacks that were treated with double-blinded
study drug (either placebo or PHVS416 10, 20, or 30 mg doses).
About PHVS416 (immediate-release deucrictibant
capsules)PHVS416 (immediate-release deucrictibant
capsules) is an investigational medicine intended to treat acute
attacks of hereditary angioedema (HAE) containing deucrictibant, a
highly potent, specific, and orally bioavailable competitive
antagonist of the bradykinin B2 receptor. Pharvaris aims to develop
this formulation to provide rapid and reliable symptom relief,
through rapid exposure of attack-mitigating therapy in a
convenient, small oral dosage form. PHVS416 is currently in Phase 2
clinical development outside the U.S. for the on-demand and
proof-of-concept prophylactic treatment of HAE.
About PharvarisBuilding on its deep-seated
roots in hereditary angioedema (HAE), Pharvaris is a clinical-stage
company developing novel, oral bradykinin-B2-receptor antagonists
to treat and prevent HAE attacks. By directly targeting this
clinically proven therapeutic target with novel small molecules,
the Pharvaris team aspires to offer people with all sub-types of
HAE safe, effective, and convenient alternatives to treat attacks,
both on-demand and prophylactically. The company brings together
the best talent in the industry with deep expertise in rare
diseases and HAE. For more information, visit
https://pharvaris.com/.
Forward-Looking StatementsThis press release
contains certain forward-looking statements that involve
substantial risks and uncertainties. All statements contained in
this press release that do not relate to matters of historical fact
should be considered forward-looking statements, including, without
limitation, statements relating to our future plans, studies and
trials, and any statements containing the words “believe,”
“anticipate,” “expect,” “estimate,” “may,” “could,” “should,”
“would,” “will,” “intend” and similar expressions. These
forward-looking statements are based on management’s current
expectations, are neither promises nor guarantees, and involve
known and unknown risks, uncertainties and other important factors
that may cause Pharvaris’ actual results, performance or
achievements to be materially different from its expectations
expressed or implied by the forward-looking statements. Such risks
include but are not limited to the following: uncertainty in the
outcome of our interactions with regulatory authorities, including
the FDA with respect to the clinical holds on deucrictibant
clinical trials in the U.S.; the expected timing, progress, or
success of our clinical development programs, especially for
PHVS416 and PHVS719, which are in mid-stage global clinical trials
and are currently on hold in the U.S. as a result of the clinical
holds; risks arising from epidemic diseases, such as the COVID-19
pandemic, which may adversely impact our business, nonclinical
studies, and clinical trials; the expected timing and results of
the rodent toxicology study; the timing of regulatory approvals;
the value of our ordinary shares; the timing, costs and other
limitations involved in obtaining regulatory approval for our
product candidates PHVS416 and PHVS719, or any other product
candidate that we may develop in the future; our ability to
establish commercial capabilities or enter into agreements with
third parties to market, sell, and distribute our product
candidates; our ability to compete in the pharmaceutical industry
and with competitive generic products; our ability to market,
commercialize and achieve market acceptance for our product
candidates; our ability to raise capital when needed and on
acceptable terms; regulatory developments in the United States, the
European Union and other jurisdictions; our ability to protect our
intellectual property and know-how and operate our business without
infringing the intellectual property rights or regulatory
exclusivity of others; our ability to manage negative consequences
from changes in applicable laws and regulations, including tax
laws, our ability to successfully remediate the material weaknesses
in our internal control over financial reporting and to maintain an
effective system of internal control over financial reporting;
changes and uncertainty in general market, political and economic
conditions, including as a result of inflation and the current
conflict between Russia and Ukraine; and the other factors
described under the headings “Cautionary Statement Regarding
Forward-Looking Statements” and “Item 3. Key Information—D. Risk
Factors” in our Annual Report on Form 20-F and other periodic
filings with the Securities and Exchange Commission.
These and other important factors could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. While Pharvaris may elect to update such
forward-looking statements at some point in the future, Pharvaris
disclaims any obligation to do so, even if subsequent events cause
its views to change. These forward-looking statements should not be
relied upon as representing Pharvaris’ views as of any date
subsequent to the date of this press release.
Contact
Maggie Beller
Head of Public Relations and Communications
maggie.beller@pharvaris.com
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