Pharvaris Provides Regulatory, Clinical, and Corporate Updates
January 09 2023 - 6:50AM
Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
hereditary angioedema (HAE) attacks, today provided business
updates and company highlights.
Business Updates and Company Highlights
- Meeting minutes from Type A meeting with U.S. Food and
Drug Administration (FDA) received. Pharvaris will conduct
a 26-week rodent toxicology study to resolve the clinical holds in
the U.S. The protocol for this nonclinical study has been submitted
to the FDA for review.
- FDA approval of dosing of final U.S. participants in
RAPIDe-1 received. The FDA has agreed to partially lift
the hold on on-demand to allow the two remaining U.S. participants
in RAPIDe-1 to complete treatment of the last attack per the
protocol. Positive top-line data from RAPIDe-1 was announced in
December 2022. RAPIDe-2, a long-term extension study of PHVS416 for
the on-demand treatment of HAE, is currently on hold in the U.S.
and is underway outside the U.S.
- Top-line data from CHAPTER-1, a global Phase 2 study of
PHVS416 for the prophylactic treatment of HAE attacks, anticipated
2H2023. CHAPTER-1 is currently on hold in the U.S. All
active sites outside of the U.S. continue to recruit participants
in the CHAPTER-1 clinical study. After being notified of the
clinical holds in the U.S. by the FDA, Pharvaris informed
country-specific regulatory authorities in Canada, Europe, Israel,
and the UK regarding the clinical holds in the U.S. To date, the
regulatory status of the CHAPTER-1 study outside the U.S. remains
unchanged. Based on the Company’s current assumptions regarding
ex-U.S. regulatory status and enrollment, Pharvaris anticipates
announcing top-line data from the CHAPTER-1 trial in 2H2023.
- Cash runway into 4Q2024. Pharvaris remains
diligent in its operational management and is focusing on its
existing clinical HAE pipeline to extend runway into 4Q2024.
Upcoming Data Presentation
- American Academy of Allergy, Asthma & Immunology
(AAAAI) Annual Meeting. San Antonio, TX, February 24-27,
2023. Details for the accepted poster presentation at AAAAI are as
follows:
- 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: Prof. Marcus Maurer
- Date, Time: Sunday, February 26, 2023,
9:45-10:45 a.m. CST
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, for 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 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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