Verona Pharma Initiates U.S. Clinical Pharmacokinetic Study for RPL554 Following Acceptance of IND Application by FDA
05 June 2017 - 10:30PM
Verona Pharma plc (AIM:VRP) (NASDAQ:VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative therapeutics for the treatment of
respiratory diseases with significant unmet medical needs,
announces today the initiation of a clinical pharmacokinetic trial
in the United States for the Company's product candidate, RPL554,
following the acceptance of an Investigational New Drug application
(“IND”) by the U.S. Food and Drug Administration (“FDA”). The
first subjects have been enrolled and dosed in the study.
RPL554 is a first-in-class, inhaled, dual
inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have
anti-inflammatory as well as bronchodilator properties, and is
currently in development for the treatment of chronic obstructive
pulmonary disease (“COPD”) and cystic fibrosis (“CF”).
This complete block two-way crossover trial will
investigate the oral bioavailability and pharmacokinetics (“PK”) of
nebulized RPL554 in 12 healthy volunteers. The study will also
assess the tolerability and safety of single nebulized doses of
RPL554. The oral bioavailability examines the potential
contribution arising from the absorption of the swallowed portion
of a nebulized dose of RPL554 to its systemic bioavailability.
Top-line data is expected in the fourth quarter 2017.
“We are pleased that the IND for RPL554 has been
accepted by the FDA and to initiate clinical studies with RPL554 in
the United States", said Jan-Anders Karlsson, PhD, CEO of Verona
Pharma. "This study will support further development of RPL554 to
address unmet clinical needs in patients suffering from COPD and
other debilitating respiratory diseases.”
About Verona Pharma plc
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercialising
innovative therapeutics for the treatment of respiratory diseases
with significant unmet medical needs.
Verona Pharma’s product candidate, RPL554, is a
first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 that acts as both a bronchodilator and an
anti-inflammatory agent in a single compound. Verona Pharma is
developing RPL554 for the treatment of COPD, CF, and potentially
asthma.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements contained in this press release that do
not relate to matters of historical fact should be considered
forward-looking statements.
These forward-looking statements are based on
management's current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from our expectations expressed or implied by the forward-looking
statements, including, but not limited to, statements regarding the
design of the PK clinical trial of RPL554, the timing and
availability of top-line data for the PK clinical trial, and the
importance of the PK clinical trial to our development plans for
RPL554.
These and other important factors under the
caption “Risk Factors” in our final prospectus filed with the
Securities and Exchange Commission (“SEC”) on April 28, 2017
relating to our Registration Statement on Form F-1, and our other
reports filed with the SEC, 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. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
For further information please contact:
Verona Pharma plc |
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Tel: +44 (0)20 3283
4200 |
Jan-Anders Karlsson,
Chief Executive Officer |
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info@veronapharma.com |
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N+1 Singer (Nominated
Adviser and UK Broker) |
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Tel: +44 (0)20 7496
3000 |
Aubrey Powell / James
White |
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FTI Consulting (UK
Media and Investor Enquiries) |
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Tel: +44 (0)20 3727
1000 |
Simon Conway /
Stephanie Cuthbert / Natalie Garland-Collins |
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veronapharma@fticonsulting.com |
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ICR, Inc. (US Media and
Investor Enquiries) |
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James Heins |
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Tel: +1 203 682
8251 |
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James.Heins@icrinc.com |
Stephanie
Carrington |
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Tel: +1 646 277
1282 |
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Stephanie.Carrington@icrinc.com |
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