Verona Pharma PLC FDA Authorisation to Proceed RPL554 Investigation (5435C)
18 April 2017 - 4:00PM
UK Regulatory
TIDMVRP
RNS Number : 5435C
Verona Pharma PLC
18 April 2017
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.
Verona Pharma Receives Authorization from the U.S. FDA to
Proceed with Clinical Investigation of RPL554 with the Acceptance
of Investigational New Drug Application
18 April 2017, London - Verona Pharma plc (AIM: VRP) ("Verona
Pharma" or the "Company"), a clinical-stage biopharmaceutical
company focused on developing and commercialising innovative
therapeutics for the treatment of respiratory diseases, announced
today that the U.S. Food and Drug Administration has authorized the
initiation of a pharmacokinetic ("PK") clinical trial in the U.S.
for the Company's product candidate, RPL554, with the acceptance of
an Investigational New Drug application ("IND").
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, currently
in development for the treatment of chronic obstructive pulmonary
disease and cystic fibrosis.
With the IND effective, the Company plans to initiate a PK
clinical trial in the middle of this year in approximately 12
healthy volunteers to determine the oral bioavailability of RPL554,
as well as assess the safety and tolerability of the drug. Top-line
data is expected in the fourth quarter of 2017.
"We look forward to initiating the first clinical trial with
RPL554 in the U.S.," said Jan-Anders Karlsson, PhD, CEO of Verona
Pharma. "This important regulatory milestone reinforces Verona
Pharma's commitment to bring a novel therapeutic option with both
bronchodilator and anti-inflammatory effects to patients with
chronic, debilitating respiratory conditions that are not well
treated by existing medicines."
-ENDS-
For further information, please contact:
Verona Pharma plc Tel: +44 (0)20 3283
4200
------------------------------------- --------------------------------
Jan-Anders Karlsson, Chief Executive info@veronapharma.com
Officer
------------------------------------- --------------------------------
N+1 Singer (Nominated Adviser and Tel: +44 (0)20 7496
UK Broker) 3000
------------------------------------- --------------------------------
Aubrey Powell / James White
------------------------------------- --------------------------------
FTI Consulting (UK Media and Investor Tel: +44 (0)20 3727
enquiries) 1000
------------------------------------- --------------------------------
Simon Conway / Stephanie Cuthbert veronapharma@fticonsulting.com
/
Natalie Garland-Collins
------------------------------------- --------------------------------
ICR, Inc. (US Media and Investor
enquiries)
------------------------------------- --------------------------------
Darcie Robinson Tel: +1 203-682-8379
Darcie.Robinson@icrinc.com
------------------------------------- --------------------------------
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com
------------------------------------- --------------------------------
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 chronic obstructive pulmonary disease (COPD), cystic
fibrosis, 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
timing of initiation of our PK clinical trial and the availability
of top-line data, the design of our PK clinical trial, and the
importance of the IND to our product development plans.
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. 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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