Pharvaris Highlights Data Supporting Clinical Development Program for Hereditary Angioedema at the 2022 Bradykinin Symposium
September 16 2022 - 4:45AM
Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today presented data
supporting the development program for PHA121 at the Bradykinin
Symposium 2022 in Berlin.
The presentation, titled “Development of PHA121 for On-Demand
and Prophylactic Treatment of HAE,” occurred on Friday, September
16, at 10:45 a.m. CEST, and included preclinical and clinical data
supporting Pharvaris’ development strategy for two oral therapies
for both the on-demand and prophylactic treatment of HAE attacks.
The data demonstrate that PHA121, the active ingredient in PHVS416
and PHVS719, is 25-fold more potent than icatibant at inhibiting
bradykinin interaction with the endogenous human B2 receptor.
Tailored formulations of PHA121 achieved exposure levels predicted
from a human bradykinin challenge study to be effective in treating
acute HAE attacks and reducing the likelihood of HAE attacks with a
convenient single-dose oral administration. The presentation
included data supporting the suitability of the pharmacokinetics of
PHVS416 for the on-demand treatment of HAE with therapeutic
exposure above EC85 within 30 minutes and of PHVS719 daily for the
prophylactic treatment of HAE with extended release and absorption
from the GI tract providing the necessary therapeutic exposure for
more than 24 hours.
“Inhibition of bradykinin signaling via B2-receptor antagonism
addresses the fundamental mechanism that leads to HAE symptoms,”
said Anne Lesage, Ph.D., Chief Early Development Officer. “The data
presented demonstrate that both formulations of PHA121 provide
exposures of PHA121 that are predicted to prevent or treat attacks
of HAE with profiles tailored to each setting. Pharvaris is
uniquely positioned to develop improved HAE therapies due to our
deep history in bradykinin-B2-receptor antagonist drug development.
The pharmacokinetic data shown for the two oral formulations of
PHA121 continue to support the investigation of PHVS416 and PHVS719
for the treatment of HAE.”
A copy of the presentation is available on the Events &
Presentations section of the company’s website at
https://ir.pharvaris.com/news-events/events-presentations.
About PHVS416PHVS416 is an investigational
softgel capsule formulation containing PHA121, a highly potent,
specific, and orally bioavailable competitive antagonist of the
bradykinin B2 receptor. Pharvaris aims to develop this formulation
to provide fast and reliable symptom relief, through rapid exposure
of attack-mitigating therapy in a convenient, small oral dosage
form. In healthy volunteers, a single dose of PHVS416 showed rapid
exposure exceeding predicted therapeutically efficacious levels
within 15 minutes. PHVS416 is currently in Phase 2 clinical
development for the on-demand treatment of HAE.
About PHVS719PHVS719 is an investigational
extended-release tablet formulation containing PHA121, a highly
potent, specific, and orally bioavailable competitive antagonist of
the bradykinin B2 receptor. Pharvaris is developing this
formulation to provide an easy way to prevent attacks with
sustained exposure of attack-preventing medicine in a convenient,
small oral dosage form. PHVS719 is currently in Phase 1 clinical
development for the prophylactic treatment of HAE. In healthy
volunteers, a single dose of PHVS719 was well tolerated with an
extended-release profile supporting once-daily dosing.
About PHA121PHA121 (PHA-022121) is a highly
potent, specific, and orally bioavailable competitive antagonist of
the bradykinin B2 receptor that has completed Phase 1 clinical
development. PHA121 utilizes the same mechanism as icatibant, the
leading therapy for on-demand treatment of HAE. Pharvaris is
developing this novel small molecule for on-demand and prophylactic
treatment of HAE and other bradykinin-mediated diseases through
formulations optimized for each setting. Data from single- and
multiple-ascending-dose Phase 1 studies in healthy volunteers
demonstrate rapid exposure and linear pharmacokinetics at doses up
to 50 mg. In a bradykinin-challenge study in healthy volunteers,
PHA121 showed significant inhibition of bradykinin-induced
hemodynamic changes with an average composite EC50 of 2.4 ng/mL and
EC85 of 13.8 ng/mL, approximately four-fold more potent than
historical data for icatibant. Quantitative modeling indicates that
single oral doses of PHA121 will maintain pharmacological
effectiveness for a substantially longer time than 30 mg of
subcutaneous icatibant. In clinical studies, PHA121 has been
observed to be well-tolerated at all doses studied to date.
About PharvarisPharvaris is a clinical-stage
company developing novel, oral bradykinin-B2-receptor antagonists
to treat and prevent HAE attacks, building on its deep-seated roots
in HAE. 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 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 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 hold on PHA121 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 hold; risks associated
with the COVID-19 pandemic, which may adversely impact our
business, nonclinical studies, and clinical trials; 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 weakness
in our internal control over financial reporting and to maintain an
effective system of internal control over financial reporting;
changes in general market, political and economic conditions,
including as a result of 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.
ContactMaryann CiminoDirector of Corporate
Relationsmaryann.cimino@pharvaris.com +1-617-710-7305
Pharvaris NV (NASDAQ:PHVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pharvaris NV (NASDAQ:PHVS)
Historical Stock Chart
From Apr 2023 to Apr 2024