Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
HAE attacks, building on its deep-seated roots in hereditary
angioedema (HAE), today announced the presentation of its
development program at the Kinin 2022 Conference, to be held June
5-8, 2022, in Annecy, France. The satellite symposium titled,
"Tailored drug development for patients living with HAE," was
delivered on Tuesday, June 7, at 13:00 CEST by Anne Lesage, Ph.D.,
chief early development officer at Pharvaris.
The satellite symposium explored the attributes and mechanism of
HAE; the pharmacodynamic (PD) and pharmacokinetic (PK)
characteristics of Pharvaris’ novel, orally bioavailable, highly
potent and selective B2 receptor antagonist; and, preclinical and
clinical data supporting Pharvaris’ development strategy of two
oral therapies for both the on-demand and prophylactic treatment of
all HAE attacks.
“The data presented at Kinin 2022 demonstrate that our molecule
shows rapid onset of effect, and, relative to icatibant, higher
potency in a surrogate endpoint and longer half-life which may lead
to more effective symptom mitigation,” said Dr. Lesage.
“Bradykinin-B2-receptor antagonism is effective in treating HAE but
is currently unavailable as an oral treatment. Pharvaris is
designing oral product candidates for both on-demand use, and
prophylactic use, in the form of softgel PHVS416 capsules and
extended-release PHVS719 tablets, respectively. The data presented
in the satellite symposium support the development strategy
implemented by Pharvaris to prevent and treat painful HAE attacks
through a convenient oral route of administration.”
Berndt Modig, chief executive officer of Pharvaris, added, “We
continue to advance our therapeutic pipeline to better understand
the product profile of each of our candidates. The Phase 2 RAPIDe-1
study investigating PHVS416 for the on-demand treatment of HAE
attacks has reached target patient enrollment, and we continue to
enroll patients in our ongoing Phase 2 CHAPTER-1 clinical trial for
the prophylactic treatment of HAE attacks. At Pharvaris, we remain
committed to providing people living with HAE additional treatment
alternatives.”
As presented in the satellite symposium, Pharvaris is developing
oral products that are highly potent, specific, and orally
bioavailable competitive antagonists of the bradykinin B2 receptor,
which utilize the same mechanism as icatibant, the leading therapy
for on-demand treatment of HAE. Preclinical in vitro studies
demonstrate PHA121, the active ingredient in PHVS416 and PHVS719,
is 25-fold more potent than icatibant at competing with the
endogenous human B2 receptor, and preclinical in vivo data
demonstrate oral PHA121 inhibits bradykinin with longer duration
and faster onset than subcutaneous icatibant. Phase 1 studies in
healthy volunteers demonstrate oral pre-treatment with PHA121
blocks the effect of bradykinin-induced hemodynamic changes.
Additional data on PHA121 gut absorption and fecal excretion in
animal models confirm high oral bioavailability and low excretion.
Together, studies in vitro, ex vivo, and in vivo demonstrate that
PHA121 is 20- to 25-fold more potent than icatibant.
The presentation will be available on the Investors section of
the Pharvaris website at:
https://ir.pharvaris.com/news-events/events-presentations for 30
days.
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 is developing this formulation to
provide fast and reliable symptom relief when patients want,
through rapid exposure of attack-mitigating medicine 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 for the treatment of HAE. 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. 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 more 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: the expected timing,
progress, or success of our clinical development programs,
especially for PHVS416 and PHVS719, which are in mid-stage clinical
trials; 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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