Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today announced the
presentation of preclinical and clinical data of PHA121, and its
two formulations – softgel capsule PHVS416 and extended-release
tablet PHVS719, for the treatment of HAE at the 2022 HAEi Global
Leadership Workshop being held October 6-9, 2022, in Frankfurt,
Germany. The poster, titled “Development of two novel oral
formulations of a first-in-class bradykinin B2 receptor antagonist
for on-demand and prophylactic treatment of hereditary angioedema,”
was presented by Marcus Maurer, M.D., Professor of Dermatology and
Allergy, Executive Director of the Institute of Allergology at the
Charité – Universitätsmedizin Berlin, and Co-Director of
Allergology and Immunology at the Fraunhofer Institute for
Translational Medicine and Pharmacology ITMP.
“Treating HAE requires addressing excess bradykinin
in the body as bradykinin is the direct cause of HAE attacks,” said
Dr. Maurer. “Although there are approved therapies for people
living with HAE around the globe, there is still an unmet need
related to treatment efficacy, tolerability, and administration
preference. Novel, safe, and effective treatments are in
development to address the need of the HAE community.”
The poster included preclinical and clinical data
supporting Pharvaris’ development strategy for two oral therapies,
one for on-demand treatment and one for prophylactic treatment of
HAE attacks. Preclinical in-vitro and ex-vivo studies demonstrate
that PHA121, the active ingredient in PHVS416 and PHVS719, is
25-fold more potent than icatibant at inhibiting bradykinin
activation of 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 poster 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.
Peng Lu, M.D., Ph.D., Chief Medical Officer of
Pharvaris, added, “By tailoring the formulations of PHA121,
Pharvaris has developed two distinct oral therapeutic candidates to
specifically address the unmet need of those living with HAE. The
softgel capsule, PHVS416, has shown to have a rapid onset of
action, which is preferred for the on-demand treatment of HAE,
while the extended-release tablet formulation, PHVS719, has shown
sustained therapeutic exposure, which supports its use in
prophylaxis. We remain ever grateful to the HAE community, clinical
trial participants, and site investigators and staff, without whom
we would not be able to continue to advance science as we strive to
improve treatment options for people living with HAE.”
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 30 minutes. 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 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
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