Allergy Therapeutics
plc
("Allergy
Therapeutics", "ATL" or the "Group")
Allergy Therapeutics
announces positive interim analysis data from the Phase I/IIa VLP
Peanut PROTECT Trial
· Interim efficacy biomarker
analysis of the first two of four peanut allergic patient cohorts
demonstrates a positive and consistent immunological response to
VLP Peanut
· Dose-dependent reduction in
wheal size after skin-prick testing indicates the skin is becoming
significantly less reactive to peanut extract in patients receiving
VLP Peanut compared to placebo
· Observed biomarker profile,
including induction of protective antibodies and reduced basophil
reactivity at relatively low doses, suggests that VLP Peanut has
the potential to simultaneously elicit a strong boost of the immune
system while suppressing an allergic response
04
December 2024 Allergy Therapeutics
(AIM: AGY), the fully integrated commercial biotechnology company
specialising in allergy immunotherapies, today announces positive
interim biomarker efficacy data from its Phase I/IIa VLP Peanut
PROTECT trial, demonstrating the first evidence of treatment effect
in peanut allergic patients.
Interim analysis of the first two
cohorts of peanut allergic patients showed that treatment with VLP
Peanut resulted in a meaningful dose-dependent reduction in skin
sensitivity to peanut allergen, with treated patients in cohort 2
showing a 48% reduction in wheal size after skin-prick test
compared to an 8% reduction in those treated with
placebo.
Additionally, a comparison of the
biomarker profile between treatment and placebo points to VLP
Peanut driving a reduction in allergic response to the major peanut
allergen (Ara h2):
· A
protective dose-dependent inhibition of Ara h2 IgE binding to B
cells was observed after treatment with VLP Peanut compared to
placebo. This inhibitory effect is indicative of how VLP Peanut
induces blocking antibodies that may reduce the pro-allergic
response.
· A
trend towards a reduction of both basophil sensitivity and basophil
reactivity to Ara h2 was seen, especially for the higher VLP Peanut
dose, and an induction of protective specific IgG towards the major
peanut allergen Ara h2 was observed compared to placebo.
This interim analysis stage involved
12 peanut allergic patients across three treatment groups. The data
represents the first demonstration of an immunologic response using
a nanoparticle-based approach in peanut allergic patients.
Following administration of initial escalating doses, patients
underwent comprehensive assessment including skin-prick testing
with whole peanut extract and blood sampling to identify key
biomarkers of efficacy. As previously
communicated, no relevant safety
signals have been observed to date.
Prof. Mohamed Shamji, Imperial College London,
commented: "Peanut allergy affects around 3% of the
worldwide population and there remain gaps in current therapeutic
options. Novel therapeutics are needed and the interim findings
from the PROTECT study demonstrate a desirable clinical immunologic
response. This includes a reduction in skin reactivity and basophil
responsiveness in peanut allergic patients and a dose-dependent
induction of IgG antibodies with inhibitory activity of IgE binding
to B-Cells. Taken together, these findings support the modulation
of the peanut induced allergic response and supports VLP Peanut
being potentially effective and safe as a novel therapeutic for
peanut allergy.''
Manuel Llobet, Chief Executive Officer of Allergy
Therapeutics, commented: "These initial efficacy
results mark an important milestone for our peanut allergy
programme. The consistency in immunological response seen at these
early doses is particularly encouraging. Combined with the positive
safety profile, this data supports our plans to progress to higher
doses in the remaining cohorts as we work towards identifying an
optimal therapeutic dose for phase II
development."
More information about the PROTECT
trial can be found on ClinicalTrials.gov
under the identifier
NCT05476497.
- ENDS -
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
Healthcare
Mary-Jane Elliott / David Daley /
Davide Salvi
+44 (0)20 3709 5700
allergytherapeutics@icrhealthcare.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 immunotherapies 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 the PROTECT Trial
The PROTECT trial is being conducted in both healthy subjects and peanut
allergic patients and consists of Part A and Part B. Part A
involves subcutaneous immunotherapy (SCIT) dosing in healthy
subjects (Group A1) and skin-prick testing in peanut allergic
patients (Group A2), the latter of which was completed in April
2023.
Part B of the clinical trial is
double-blind, placebo-controlled and has commenced in patients with
peanut allergy at multiple clinical trial sites in the US. Up to 36
peanut-allergic patients will be enrolled in Part B of the clinical
trial, should the dosing advance to the highest dose as currently
planned.