Allergy Therapeutics PLC Invalidation of Birch MATA MPL phase III results (4647S)
09 July 2020 - 4:00PM
UK Regulatory
TIDMAGY
RNS Number : 4647S
Allergy Therapeutics PLC
09 July 2020
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
Allergy Therapeutics announces invalidation of the Birch MATA
MPL Phase III primary endpoint results
- Technical issues with the endpoint measurements invalidated B301 trial
- New pivotal Phase III Study with Birch MATA MPL to be conducted within TAV time frame
09 July 2020 Allergy Therapeutics plc (AIM: AGY), the fully
integrated commercial biotechnology company specialising in allergy
vaccines, today is pleased to announce the outcome of scientific
advice from the German Regulatory Authority, the Paul Ehrlich
Institute (PEI), regarding invalidation of the primary endpoint
data of the Birch MATA MPL pivotal Phase III clinical trial
(B301).
Further to the announcement on 18 March 2019 and following
extensive data investigations and discussions with PEI, the
analysis of the primary endpoint of the Birch B301 clinical trial
has been declared invalid. Technical issues encountered in the
study made it impossible to reconstruct the primary endpoint data
and the PEI agreed that B301 cannot be considered for assessment of
clinical efficacy and a new pivotal Phase III study will be
conducted within the therapy allergens ordinance
("Therapieallergene-Verordnung",TAV) time frame.
The Group's confidence in its short course immunotherapies
remains unchanged and lessons learned from the Birch B301 field
study have already been introduced for future studies including the
Grass MATA MPL programme to be conducted simultaneously in the US
and Europe.
Manuel Llobet, CEO at Allergy Therapeutics , commented: "We are
encouraged by our constructive discussions with the PEI who, based
upon the clear scientific evidence, decided to invalidate the
primary endpoint of the B301 study and agreed to a new pivotal
Phase III clinical study for Birch MATA MPL. We remain committed to
Birch MATA MPL, especially considering the results of the
independent secondary endpoint data and the supportive safety
profile observed in the B301 study and two successful phase II
trials showing significant primary efficacy results.
"We look forward to progressing our portfolio of unique allergy
vaccines and helping the millions of patients affected by allergy
via our phase III studies with Birch MATA MPL as well as Grass MATA
MPL and our upcoming first in human peanut trial."
This announcement contains inside information for the purposes
of Article 7 of Regulatory (EU) No596/2014.
- ENDS -
For further information, please contact: Allergy
Therapeutics
+44 (0)1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
Panmure Gordon
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Erik Anderson, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Ashley Tapp / Olivia
Manser
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial
biotechnology company focussed on the treatment and diagnosis of
allergic disorders, including immunotherapy vaccines that have the
potential to cure disease. The Group sells proprietary and third
party products from its subsidiaries in nine major European
countries and via distribution agreements in an additional ten
countries. Its broad pipeline of products in clinical development
include vaccines for grass and tree with a peanut allergy vaccine
in pre-clinical development. Adjuvant systems to boost performance
of vaccines outside allergy are also in development.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics
is headquartered in Worthing, UK with more than 11,000m(2) of
state-of-the-art MHRA-approved manufacturing facilities and
laboratories. The Group, which has achieved double digit compound
annual growth since formation, employs c.500 employees and is
listed on the London Stock Exchange (AIM:AGY). For more
information, please see www.allergytherapeutics.com .
About Birch MATA MPL
Birch MATA MPL is a subcutaneous allergen-specific immunotherapy
designed to treat the cause of allergic rhinitis not just mask the
symptoms. It consists of a birch pollen allergoid combined with an
adjuvant system comprised of microcrystalline tyrosine (MCT) and
monophosphoryl lipid A (MPL(R) ).
Allergoids (natural allergens chemically modified to form
allergoids) exhibit reduced allergenicity that improves
tolerability and allows for delivery of higher doses. These
allergoids are combined with an adjuvant system including depot
adjuvant technology MCT to provide enhanced immune exposure and
further improved tolerability and MPL(R) to enhance and direct the
immune response. MPL is a toll-like receptor 4 (TLR4) agonist that
has been extensively used in the Group's other allergy vaccines
available on the market and in vaccines registered in the USA.
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END
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