
Bought in this morning...@5.45p showed as a sell. Prospects are good. There are targets of 14p around
20 May 2009
Verona Pharma plc
("Verona Pharma" or the "Company")
First two stages of RPL554 Phase I/IIa Clinical Trial Yields Positive Results
Approval to proceed to final stage of trial
Verona Pharma, the AIM-quoted drug discovery company, is pleased to announce
that its asthma and allergic rhinitis (hay fever) treatment, RPL554, has
successfully completed the first two stages of its Phase I/IIa clinical trial
and received approval to proceed to the final stage of the trial. RPL554 is a
novel inhaled treatment for asthma and hay fever that does not involve
traditional steroids or beta agonists, and therefore does not have the side
effects associated with these treatments.
HIGHLIGHTS
* Approval to proceed RPL554 to the final stage of its Phase I/IIa clinical
trial
* Strengthening Verona Pharma's portfolio of drugs
* Well-positioned to enter licensing should RPL554 successfully complete the
final stage of the Phase I/IIa trial
The trial results for RPL554 at stages 1 and 2 of its three stage Phase I/IIa
clinical trial were such that the Ethics Committee overseeing the Centre for
Human Drug Research in Leiden, the Netherlands, where the trial is being
carried out, has given approval for the trial to proceed to the final stage.
Stage 1 of the clinical trial tested the drug's safety in healthy volunteers.
The second stage was an adaptive trial designed to explore whether the drug has
beneficial effects, in terms of bronchodilation and bronchoprotection in
asthmatics, while allowing further safety testing and selection of an
appropriate dose for the final trial stage.
RPL554 is now entering stage 3 of the clinical trial which is expected to be
completed in Q3 of 2009.
The third and final stage of the trial is designed as a randomised,
double-blinded placebo-controlled crossover trial in a group of 10 allergic
asthmatic and 10 allergic rhinitis patients. This will test whether the drug,
at the dose selected on the basis of the stage 2 results, has both
bronchodilator and bronchoprotective effects within the lung airways of
asthmatics, as well as anti-inflammatory actions within the nasal airways of
allergic rhinitics.
Verona Pharma retains a strong balance sheet and cash position after funding
the cost of this trial. Furthermore, Verona Pharma's management and development
teams have a wealth of experience in the pharmaceutical industry as well as a
portfolio of novel drug treatments alongside RPL554.
Chief Executive Dr. Michael Walker said:
"We are delighted with the results of stages 1 and 2 and look forward to moving
the drug into the final stage 3 of our Phase I/IIa clinical trial that is
designed to demonstrate both safety and effectiveness in the treatment of
asthma and rhinitis.
"It has always been our strategy to develop our compounds to a stage where
pharmaceutical companies can see proven potential as drugs before entering into
a partnership or licensing them to a third party. With RPL554 entering the
final stage of its pivotal Phase I/IIa trial, we will actively pursue the
possibilities for potential licensing agreements or partnerships to
commercialise RPL554.
"We believe that the Company is currently in a very strong position, with
RPL554 reaching the final stage of its clinical trial and two further projects
in the pipeline. A number of large international pharmaceutical companies'
patents are due to expire over the next 12 months leaving them open to the
possibility of the market being flooded with cheaper generic equivalents. This
in turn offers Verona Pharma substantial potential opportunities for our new
unique patented treatments."