Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today announced it will be
presenting two in-person “ePoster – Meet the Author” presentations
at the American College of Allergy, Asthma & Immunology (ACAAI)
Annual Scientific Meeting 2022, being held from November 10-14,
2022, in Louisville, Ky.
“The data presented at ACAAI demonstrate the optimized
pharmacokinetic and tolerability profiles of Pharvaris’ drug
candidates that are in clinical development for the treatment of
HAE,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of
Pharvaris. “PHVS719 is designed to be a once-daily prophylactic
treatment for the prevention of HAE attacks, as supported by data
demonstrating compound absorption in the colon and maintained
exposure above predicted therapeutic levels. The cross-over
pharmacokinetic data described in the second poster support the
dosing regimen in CHAPTER-1, a Phase 2 study evaluating PHVS416 as
a proof of concept of PHVS719 for the prophylactic treatment of
HAE.”
Presentation details and key data highlights include:
- Title: Development of PHVS719: an Oral
Extended-Release Bradykinin B2 Receptor Antagonist to Prevent
Hereditary Angioedema AttacksPresentation ID:
P064Date and Time: Saturday, November 12, 2022,
12:05 p.m. ESTLocation: Exhibition Hall (Upper
Concourse), Monitor 10
Pharmacokinetic properties of PHA121 were evaluated to support
the intended therapeutic use of PHVS719 for the prophylactic
treatment of HAE attacks using preclinical and clinical
experimental models. Colonic absorption of PHA121 was investigated
as a requisite for prolonged absorption of the extended-release
formulation under development. In rodents, plasma concentrations
following oral and intracolonic administrations of PHA121 were
comparable, providing evidence that PHA121 can be systemically
absorbed by colonic mucosa. In humans, high oral bioavailability
and low fecal excretion further indicate almost-complete absorption
in the gastrointestinal tract. Together, these data support
clinical development of the extended-release tablet PHVS719 as a
once-daily prophylactic treatment of HAE attacks.
- Title: Pharmacokinetics of PHVS719,
extended-release tablet formulation of PHA121, a first-in-class
oral human bradykinin B2-receptor antagonistPresentation
ID: P068Date and Time: Sunday, November
13, 2022, 11:50 a.m. ESTLocation: Exhibition Hall
(Upper Concourse), Monitor 10
In the Phase 1 pharmacokinetic study of PHVS719, 10 healthy
subjects received, in a randomized order, two different doses of
PHVS719 extended-release tablets (XR1 at 20 mg and XR2 at 40 mg),
in fasting and in fed conditions, and one dose of PHVS416 20 mg in
fasting conditions. Measurement of
time-to-reach-therapeutic-exposure-levels for PHA121 above the EC85
of 13.8 ng/mL showed that after administration of XR1 and XR2,
therapeutic plasma concentrations were achieved within
approximately two hours. Concentrations of PHA121 remained at
therapeutic levels for at least 30 hours with XR2. Food intake did
not have significant effects on the time to reach therapeutic
exposure of PHA121 nor on the time at which concentrations remained
at therapeutic levels. The 24-hour area-under-the-curve exposure of
PHA121 after XR2 was comparable to that observed in Phase 1 studies
with PHVS416 softgel capsules dosed at 20 mg bid with food.
Administration of both PHVS719 and of PHVS416 were well tolerated.
No severe nor serious treatment-emergent adverse events were
reported, with no specific safety pattern or trend in number or
type of events. The 10 treatment-emergent adverse events that were
reported in 50% of the participating subjects were mainly of Grade
1 severity or of Grade 2 severity, occurred after only one of the
administrations of study drugs, and all completely resolved. Two of
these events, namely neck pain and post-procedural hypotension,
were considered as not related to the study drug. PHVS416, a
softgel capsule formulation of PHA121 is being evaluated for safety
and efficacy outcomes in CHAPTER-1, a Phase 2 proof of concept
clinical trial, which is currently ongoing in countries outside the
U.S. The U.S. Food and Drug Administration has placed on hold on
clinical trials of PHA121 in the U.S.
The posters are available on the Investors section of the
Pharvaris website at:
https://ir.pharvaris.com/news-events/events-presentations.
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 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 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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