Positive Phase 2 Data from RAPIDe-1 Study of PHVS416 for the On-Demand Treatment of HAE Attacks Highlighted at the 2023 HAEi Regional Conference APAC
March 18 2023 - 12:35AM
Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today announced an oral
presentation of positive data from its Phase 2 RAPIDe-1 study of
PHVS416 for the on-demand treatment of attacks at the 2023 HAEi
Regional Conference APAC, taking place in Bangkok, Thailand, on
March 17-19, 2023.
Presentation Details
- Title: Efficacy and Safety of Bradykinin B2
Receptor Inhibition with Oral PHVS416 in Treating Hereditary
Angioedema Attacks: Results of RAPIDe-1 Phase 2 Trial
- Presenter: Marc A. Riedl, M.D., M.S.,
Professor of Medicine, Clinical Director of the US Hereditary
Angioedema Association (HAEA) Angioedema Center at the University
of California San Diego (UCSD), and Clinical Service Chief for
Allergy/Immunology at UCSD
- Date, Time: Saturday, March 18, 11:35 a.m. ICT
(12:35 a.m. EDT)
Dr. Riedl commented, “Currently approved on-demand therapies for
HAE attacks are administered intravenously or subcutaneously and
can be associated with treatment burden. The time required for
preparation and administration, as well as potential occurrence of
pain, discomfort, or other injection site reactions can lead to
treatment delays or untreated HAE symptoms. An unmet need exists
for on-demand oral therapies that are effective and well-tolerated,
and that may reduce the treatment burden, enabling prompt
administration as recommended by clinical guidelines. The
consistent results across all endpoints in the RAPIDe-1 trial
provide evidence supporting the efficacy and well-tolerated profile
of PHVS416 in treating HAE attacks and provide a foundation for its
further development as a potential on-demand therapy.”
RAPIDe-1 is a Phase 2, double-blind, placebo-controlled,
randomized, cross-over, dose-ranging trial of PHVS416, the oral
softgel capsule formulation of PHA121, 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.
74 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). Analysis
of the primary endpoint demonstrated that PHVS416 significantly
(p<0.0001; nominal p value for 10 mg dose) reduced attack
symptoms measured as change in the mean 3-symptom composite (skin
pain, skin swelling, abdominal pain) visual analogue scale (VAS-3)
score during HAE attacks, at four hours compared with placebo (LS
mean difference of change in VAS-3: -16.75, -15.02, and -16.28 for
PHVS416 10, 20 and 30 mg, respectively, vs. placebo). All key
secondary efficacy endpoints were also met. Participants on PHVS416
also used substantially less rescue medication compared to placebo
(10 mg=18.9%, 20 mg=10.7%, 30 mg=6.5%, placebo=60.8%). PHVS416 was
generally well tolerated with three treatment-related adverse
events (TRAEs) reported for one PHVS416 30-mg-treated attack (2.8%)
and one TRAE reported for one placebo-treated attack (1.9%).
The presentation slides will be available on the Investors
section of the Pharvaris 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 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 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 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 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 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 holds;
risks arising from epidemic diseases, such as the COVID-19
pandemic, which may adversely impact our business, nonclinical
studies, and clinical trials; the timing of our 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 weakness 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.
ContactMaryann CiminoDirector of Corporate
Relationsmaryann.cimino@pharvaris.com +1-617-710-7305
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