Clinical update

Allergy Therapeutics PLC
10 February 2006



 Allergy Therapeutics plc announces commencement of sublingual allergy vaccine
                                 trial - MPL103

      'First in Man' experience with MPL(R) administered under the tongue


Allergy Therapeutics plc, "ATp" or "the Company", the specialty pharmaceutical
Company focused on allergy vaccination, today announces that its Phase I/II
clinical trial, MPL103, has commenced. The MPL103 study, if successful, will
show that sublingual (under the tongue) vaccines demonstrate improved activity
with the addition of MPL(R). MPL(R) (Monophospheryl Lipid A) is the Company's
innovative TLR4-agonist used as an adjuvant for vaccines.


The study is being carried out in Germany and is a milestone in the development
of Allergy Therapeutics' short-course sublingual vaccine product range. If
successful, the study with MPL(R) will pave the way for the development of new
non-injected allergy vaccines with improved efficacy, shorter dosing and fewer
local side effects. Such sublingual vaccines would have the potential to
revolutionise the treatment of allergies since they offer patients an
alternative to injections and are easy to administer. There are currently no
sublingual vaccines with adjuvant available on the market.


The study will include 80 patients allergic to Grass pollen, divided into four
groups of 20 subjects each. In each group, 4 subjects will receive placebo and
16 will receive the active substance. Patients will keep a record of any
side-effects, and blood samples will be taken to test for immunological changes.
The patients will be given a nasal provocation challenge to assess changes in
symptoms. Treatment is daily; analysis is weekly at the beginning and bi-weekly
at the end over a 10 week period. Preliminary results from the first three
groups should be available in the summer.


Commenting on the study, Keith Carter, Chief Executive Officer, said:

"I am delighted to announce the commencement of our sublingual allergy vaccine
trial. First in Man represents a major milestone for this product, as it marks
its transition from the pre-clinical to the clinical phases of development.

"Allergy Therapeutics is the first company to conduct human sublingual vaccine
studies with the MPL(R) adjuvant. Sublingual allergy vaccines are often
perceived to be less efficacious than injected ones. However, given our current
expertise with Oralvac(R), which is based on this delivery mode, and the
proprietary addition of MPL(R), we believe the Company has good prospects of
developing a highly efficacious sublingual product with a shorter dosing regimen
and fewer side effects. The resultant product would have improved efficacy and,
importantly, engender good patient compliance."

"This is an exciting time for Allergy Therapeutics as we continue to make good
progress in the development of our pipeline of innovative MPL-based short-course
allergy vaccines."

                                     -ends-

For further information:

Allergy Therapeutics 01903 844720
Keith Carter, Chief Executive

Bell Pottinger 020 7861 3232
Dan de Belder / Emma Charlton


About the MPL103 Study

MPL103 is a randomized, double-blind, placebo-controlled study that will
evaluate the safety, tolerability, immunological effect and efficacy of combined
application of MPL and grass pollen allergen. The study will be conducted at a
single centre in Germany and will include a total of 80 adult patients allergic
to grass pollen. The subjects will be divided in to 4 groups of 20 each. In each
group 4 subjects will receive placebo and 16 will receive the active treatment
in a double blind fashion. Groups 1, 2 and 3 will be followed using a parallel
group design and will receive extract of allergen in liquid form (at a dose
similar to company's current sublingual product) combined either with placebo or
with one of the two doses - low and high - of MPL. Subjects in group 4 will
receive the best-performing dose of MPL (chosen from the parallel group study)
combined with placebo or increasing doses of allergen extract in order to
determine the maximum tolerated dose of the combination and thus potentially to
determine the optimal dose for the phase III programme.



About MPL(R)

MPL (Monophospheryl Lipid A) is an immunostimulatory substance used to enhance
the performance of vaccines (an 'adjuvant'). It has been widely tested, and can
be characterized as a Toll-Like Receptor 4 (TLR4) agonist. Allergy Therapeutics
is conducting a programme of late-phase trials in injected allergy vaccines with
the adjuvant, and GSK has several vaccine candidates containing MPL(R) including
Fendrix(R), a vaccine for Hepatitis A which was approved by the EMEA last year.

In ATp's pre-clinical studies, specific mucosal (IgA) antibodies were seen to be
induced systemically, raising the possibility that a sublingual vaccine
containing MPL(R) will show benefit in man on the basis of blocking antibodies
at the organ of allergen challenge - the mucosal layers of the nasal cavity and
the lung.


About Sublingual Allergy Vaccines

Also known as sublingual immunotherapy ('SLIT'), sublingual vaccines for
allergies causing seasonal allergic rhino-conjunctivitis (hayfever) mostly
caused by pollens, as well as perennial allergic conditions caused by allergens
such as house dust mites, have been widely used in Europe for a number of years.
Currently marketed products are relatively simple, being purified extracts of
allergens, for example grass pollen, in liquid form, dropped under the tongue
daily. The safety characteristics of these vaccines are very good and the dosing
is more attractive, being injection-free. This gives these vaccines a high
commercial potential as the numbers of patients and prescribers willing to use
the products should be large.

However, the efficacy of these treatments is generally considered to be lower
than that of injected allergy vaccines and typically the treatments continue
with daily dosing for many months. Attempts to address these issues by
increasing the allergen concentration per dose may cause unpleasant local side
effects. There are no sublingual vaccines with adjuvant available on the market
currently. ATp's current sublingual study with MPL(R) may therefore offer the
prospect of new non-injected vaccines with improved efficacy, shorter dosing and
few local side effects. ATp's patents in this area expire in 2020/2022.


About Allergy Therapeutics plc

Allergy Therapeutics plc is an AIM-listed specialty pharmaceutical company
focused on allergy vaccination. It has a profitable core business achieving
sales of allergy vaccines of over £22m in Germany, Italy, Spain and other EU
markets through its own sales and marketing infrastructure. The company is
expanding its infrastructure and recently commenced operations in the UK,
Poland, the Czech Republic and Slovakia. Marketing Authorisations were recently
obtained for Austria allowing Allergy Therapeutics under its Bencard Allergie
trading name to commence commercial operations there.


Allergy Therapeutics manufactures its own vaccine products in an MHRA approved
sterile manufacturing facility in Worthing, UK. In January 2006 the company
successfully underwent an audit by the MHRA; no critical issues were raised.


Allergy Therapeutics has certain exclusive intellectual property rights to the
use of MPL(R) in vaccines, both injected and sublingual. In addition to the
phase I/II sublingual study, the company is preparing for Phase III studies in
an ultra-short course injected allergy vaccine comprising four injections
administrable over as little as 3 weeks pre-season. Discussion with the FDA is
ongoing for this late stage programme, which it is hoped will initiate on a
worldwide basis during 2006.




                      This information is provided by RNS
            The company news service from the London Stock Exchange