Allergy Therapeutics
plc
("Allergy
Therapeutics" or "the Group")
Allergy Therapeutics
commences Phase III paediatric trial for Grass MATA
MPL
· Industry first long-term
subcutaneous allergen-specific
immunotherapy (SCIT) trial for grass pollen in paediatric
subjects
· Patient screening and
enrolment underway with topline safety and efficacy data expected
Q4 2025
21
October 2024 Allergy Therapeutics
(AIM: AGY), the fully integrated commercial biotechnology company
specialising in allergy vaccines, today announces that the first
subjects have been screened and enrolled in the Group's
Phase III G308 trial to evaluate the long-term
efficacy and safety of Grass MATA MPL in paediatric subjects.
Grass MATA MPL is the Group's
short-course subcutaneous allergen-specific immunotherapy (SCIT)
candidate that aims to address the cause of
symptoms of allergic rhinoconjunctivitis due to grass
pollen.
Incorporating MicroCrystalline
Tyrosine ("MCT®") adsorbed allergoids and the innovative
adjuvant Monophosphoryl-lipid A ("MPL"), the immunotherapy
candidate has been developed to modify the allergic response
following only six injections prior to the grass allergy
season.
Commencement of the G308 paediatric
trial follows the successful earlier
completion of the Group's
pivotal Phase III G306 trial in adults. In that trial, Grass
MATA MPL demonstrated a highly statistically significant reduction
in the Combined Symptom & Medication Score (CSMS)
compared to placebo over the peak pollen season. Building on these
positive results, G308 is designed to evaluate the long-term
efficacy and safety of the immunotherapy candidate in a paediatric
population over five years. Topline safety
and efficacy data are expected in Q4 2025.
The G308 paediatric trial
complements Allergy Therapeutics' previous studies in adults,
including the pivotal Phase III G306 trial and the exploratory G309
field study, furthering the Group's comprehensive development
strategy for Grass MATA MPL across different age groups.
Manuel Llobet, CEO of Allergy
Therapeutics, commented: "The commencement of our
long-term paediatric Phase III trial (G308) marks the first time a
SCIT grass pollen vaccine has been evaluated in a paediatric
population over the long-term, a significant milestone in the
allergy industry. Encouraged by the results of our short-course
grass pollen immunotherapy in both the successful G309 exploratory
field trial and the pivotal G306 trial, we are excited to advance
the development of this innovative treatment candidate in new
patient populations, potentially offering a transformative option
for children with grass pollen allergies."
- ENDS -
For
further information, please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive
Officer
Shaun Furlong, Chief Financial
Officer
+44 (0)1903 845 820
Cavendish Capital Markets Limited (Nominated Adviser and
Broker)
Geoff Nash /Giles Balleny/ Seamus
Fricker / Rory Sale
Nigel Birks - Life Science Specialist
Sales
Tamar Cranford Smith -
Sales
+44 (0)20 7220 0500
ICR
Consilium
Mary-Jane Elliott / David Daley /
Davide Salvi
+44 (0)20 3709 5700
allergytherapeutics@consilium-comms.com
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an
international commercial biotechnology company, headquartered in
the UK, focussed on the treatment and diagnosis of allergic
disorders, including aluminium free 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. For more information, please see
www.allergytherapeutics.com.
About Grass MATA MPL
Grass MATA MPL is being developed as
a pre-seasonal subcutaneous immunotherapy product for the treatment
of allergic rhinitis and/or rhinoconjunctivitis.
Grass MATA MPL contains an extract
of 13 grass pollens modified with glutaraldehyde to form allergoids
that reduces the reactivity with immunoglobulin E (IgE) antibodies
without a reduction in other important immunological properties,
such as T-cell reactivity. The allergoid is adsorbed to
microcrystalline tyrosine as a depot adjuvant system formulation.
Monophosphoryl lipid-A (MPL), is included as an adjuvant to
increase the immunogenic effect of the immunotherapy and to enhance
the switch from an allergen specific helper T-cell Type 2 (Th2) to
helper T-cell Type 1 (Th1) like immune response.