Pharvaris Appoints Stefan Abele, Ph.D., as Chief Technical Operations Officer
15 November 2023 - 10:50PM
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
appointment of Stefan Abele, Ph.D., as Chief Technical Operations
Officer. In this role, he will be responsible for all chemistry,
manufacturing, and controls (CMC) activities, supply chain, and
program management as Pharvaris progresses into late-stage clinical
development. Dr. Abele joins Pharvaris with more than 20 years of
experience in process development, end-to-end Active Pharmaceutical
Ingredients (API) supply chain, cross-functional CMC activities,
GMP manufacturing, global vendor management, and people leadership.
“Stefan joins Pharvaris at a transformative time as we prepare
to transition into a late-stage clinical company and prepare for
commercialization in the coming years,” said Berndt Modig, Chief
Executive Officer of Pharvaris. “His experience building
sustainable and scalable production strategies for clinical-stage
candidates and commercial-grade medicines as well as setting up
agile expert teams will be instrumental in the execution of our
Phase 3 studies and diligent preparations for commercialization. We
welcome Stefan and the insights he will bring to our executive
team.”
Dr. Abele added, “Deucrictibant could significantly improve the
current standard of care for those living with HAE and Pharvaris is
poised to make a meaningful impact on the entire HAE community. To
our knowledge, deucrictibant is the only orally bioavailable B2
receptor antagonist in development for the treatment of HAE; I am
excited to have the opportunity to join the Pharvaris team and
contribute my expertise in the development of this novel
therapeutic.”
Previously, Dr. Abele served as the Senior Vice President,
Chemical Development and Commercial Manufacturing at Idorsia
Pharmaceuticals, where he and his team were responsible for the API
development and manufacturing of QUVIVIQ (daridorexant), PIVLAZ
(clazosentan), and aprocitentan. Prior to Idorsia, Dr. Abele worked
at Actelion Pharmaceuticals where he established and grew the fully
integrated Chemistry Process R&D department. Earlier, he held
positions of growing responsibility at Carbogen-Amcis, including as
Head of Production and as a manager of teams in R&D and GMP
manufacturing of APIs for global pharma companies. Dr. Abele holds
a Diploma in Chemistry from the University of Konstanz and a Ph.D.
in Synthetic Organic Chemistry from the ETH Zurich.
About PharvarisBuilding on its deep-seated
roots in HAE, Pharvaris is a clinical-stage company developing
novel, oral bradykinin B2 receptor antagonists to treat and prevent
HAE attacks. By directly pursuing this clinically proven
therapeutic target with novel small molecules, the Pharvaris team
aspires to offer people with all sub-types of HAE efficacious,
safe, and easy-to-administer 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 relating to our future plans, studies and
trials, and any 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 prophylactic
deucrictibant in the U.S.; the expected timing, progress, or
success of our clinical development programs, especially for
PHVS416 (immediate-release deucrictibant capsules) and PHVS719
(extended-release deucrictibant tablets), which are in mid-stage
global clinical trials; risks arising from epidemic diseases, such
as the COVID-19 pandemic, which may adversely impact our business,
nonclinical studies, and clinical trials; the expected timing and
results of the rodent toxicology study and our ability to resolve
any issues to the satisfaction of the FDA or any regulatory agency
in a timely manner; 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 weaknesses 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 Hamas attack against Israel and the ensuing war;
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 U.S. 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.
Contact
Maggie Beller
Executive Director, Head of External and Internal Communications
maggie.beller@pharvaris.com
Pharvaris NV (NASDAQ:PHVS)
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