Positive Phase II Data
Evolutec Group PLC
20 September 2005
For immediate release 20 September 2005
EVOLUTEC GROUP PLC
('Evolutec' or 'Company')
POSITIVE PHASE II CLINICAL RESULT FOR rEV131
IN SEASONAL ALLERGIC RHiNITIS (HAY FEVER)
Trial meets primary endpoint; rEV131 shows efficacy and rapid onset of action
Conference call for analysts today at 3pm BST
Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel
products for the treatment of allergic, inflammatory and autoimmune diseases, is
pleased to announce, ahead of schedule, a positive clinical trial result for its
lead molecule, rEV131, in a 112 patient Phase II study in allergic rhinitis (hay
fever).
rEV131 is a recombinant version of a naturally occurring molecule identified in
ticks, parasites whose saliva contains immuno-suppressive and immuno-modulatory
molecules over which Evolutec has strong patent protection.
This Phase II dose-ranging nasal allergen challenge study of rEV131 administered
as a nasal spray was undertaken at two centres in San Antonio, Texas, under the
leadership of Dr Paul Ratner. The trial was conducted in accordance with the
Food & Drug Administration's Guidance for Industry recommendations.
The trial comprised four cohorts of 20 patients (16 active, 4 placebo), with the
active patients on ascending single doses of rEV131, followed by a fifth cohort
of 32 patients (16 active, 16 placebo) at the optimum dose. The ragweed pollen
extract was administered 30 minutes after dosing.
The trial met its primary endpoint, a statistically significant difference (p<
0.05) in the mean sum of symptom scores at 15 minutes post allergen challenge in
the 62 patients who completed the trial according to the protocol. rEV131 showed
a dose dependent drug effect enabling Evolutec to select the optimum dose for
further work to determine the onset of action and the duration of effect. There
were no significant adverse events and rEV131 was comfortable and
well-tolerated.
This result shows that rEV131 has an onset of action of 45 minutes or less -
quicker than steroid nasal sprays which have an onset of action of approximately
8 hours. The main effects of rEV131 were against congestion and mucus
production, symptoms that patients find the most troublesome and which are not
well addressed by oral antihistamines. The rapid onset of action and efficacy
against congestion and mucus underpin the potential commercial advantages of
rEV131.
Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'This result
highlights the potential of rEV131 in the $6 billion allergic rhinitis market.
We now intend to undertake a multi-dose Phase II study to define further the
onset and duration of action which will guide commercial positioning. We will
also continue our dialogue with potential partners.'
Dr. Paul Ratner, principal study investigator and Fellow of the American Academy
of Asthma, Allergy & Immunology, commented: 'I am excited about the prospect of
a novel therapeutic agent for the treatment of allergic rhinitis that is safe,
effective within 45 minutes and delivered via the intranasal route.'
ENDS
Conference call:
A conference call for analysts will be held at 3.00pm BST today to discuss the
result. The principal study investigator, Dr. Paul Ratner, will join the call.
Dial-in details:
UK 0845 245 0375
International +44 (0) 1452 555 499
PIN 734265#
For further information:
Evolutec 0118 922 4480
Mark Carnegie Brown, Chief Executive Officer
Nicholas Badman, Chief Financial Officer
www.evolutec.co.uk
Robert W. Baird 020 7488 1212
Shaun Dobson/Xavier de Mol
Buchanan Communications 020 7466 5000
Mark Court/Tim Anderson/Mary-Jane Johnson
Notes for Editors:
About Evolutec
Evolutec, which is based in Reading, UK, is a clinical stage biopharmaceutical
company with a focus on allergy, inflammation and auto-immune diseases.
The Company has just completed a positive 112 patient proof of concept Phase II
clinical trial with rEV131, its lead product, in allergic rhinitis. The company
had previously demonstrated clinical activity against the symptoms of rhinitis
when rEV131 was delivered as an eye drop. Evolutec intends to carry out
additional proof of concept Phase II trials with rEV131 in post-cataract surgery
and dry eye. Positive preclinical data has also been generated in asthma.
rEV131 is a histamine binding protein and is understood to be the only product
currently in clinical trials that impacts the recently discovered H4 receptor, a
receptor implicated in many forms of inflammatory disease.
The Company has a further two molecules in preclinical development. rEV576, a
complement inhibitor which was very effective in a preclinical model of
myasthenia gravis, and rEV598, which is being evaluated in carcinoid syndrome
and CINV (chemotherapy-induced nausea and vomiting). Evolutec is working with
Merial to develop anti-tick and anti-tick borne disease vaccines.
Evolutec was founded in 1998 to exploit research carried out by the Natural
Environment Research Council. Evolutec's drugs were first isolated from the
saliva of ticks but are now manufactured by bacterial fermentation procedures.
The tick remains undetected by its hosts, including humans, by injecting an
array of molecules into the skin that suppresses normal defence mechanisms.
These stealth molecules have evolved over millions of years to enable the tick
to take a blood meal from its host. Evolutec employs the tick's evolutionary
stealth technology to offer the potential of treating human diseases.
Safe Harbour statement: this news release may contain forward-looking statements
that reflect the current expectations of the Company regarding future events.
Forward-looking statements involve risks and uncertainties. Actual events could
differ materially from those projected herein and depend on a number of factors
including the success of the Company's research strategies, the applicability of
the discoveries made therein, the successful and timely completion of clinical
studies, the uncertainties related to the regulatory process, the successful
integration of completed mergers and acquisitions and achievement of expected
synergies from such transactions, and the ability of the Company to identify and
consummate suitable strategic and business combination transactions.
This information is provided by RNS
The company news service from the London Stock Exchange