Allergy Therapeutics
plc
("Allergy
Therapeutics", "ATL" or the "Group")
Allergy Therapeutics
commences subcutaneous dosing in peanut allergic
patients in Phase I/IIa VLP Peanut PROTECT Trial
- First patient receives
subcutaneous dosing with no safety signals
observed
- Subjects will receive a
total of three escalating doses over three separate dosing
days
- This marks the start of the
clinical proof of concept phase using biomarkers to assess
preliminary efficacy
- No safety signals observed
in the cohorts treated to date
- In addition, having already
demonstrated tolerability of a 25-fold dose increase in 2 cohorts
of healthy subjects, dose escalation in healthy subjects has
progressed to a third cohort to pave the way for dose escalation to
similar strengths in peanut allergic patients
12
March 2024 Allergy Therapeutics
(AIM: AGY), the fully integrated commercial biotechnology company
specialising in allergy vaccines, today announces the commencement
of subcutaneous dosing of peanut allergic patients in the Phase
I/IIa PROTECT trial evaluating its novel virus-like particle
(VLP)-based peanut allergy vaccine candidate ("VLP
Peanut").
Patients allergic to peanuts have
previously undergone skin-prick testing in part A of the PROTECT
trial. Following an external safety review committee (SRC), it was
determined that no safety signals had been observed and it was safe
to proceed with incremental subcutaneous dosing in healthy subjects
in the Phase I stage and in peanut allergic patients in the Phase
IIa part of the trial.
Manuel Llobet, Chief Executive Officer of Allergy
Therapeutics, commented: "This is a key milestone in
our journey to offer transformative outcomes to patients living
with peanut allergies. We are excited to begin gathering data
supportive of efficacy using biomarker technology which is aligned
with recent FDA workshop thinking on demonstrating efficacy in
clinical trials. We look forward to the complete results of this
trial and continue to work towards the required planning for the
phase II."
The PROTECT trial is being conducted in both healthy volunteers and peanut
allergic patients and consists of Part A and Part B. Part A
involves subcutaneous immunotherapy (SCIT) dosing in healthy
volunteers (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 subjects with
peanut allergy at multiple clinical trial sites in the US. Up to 36
peanut-allergic subjects will be enrolled in Part B of the clinical
trial, should the dosing advance to the highest dose as currently
planned.
The Group will announce trial
updates as is appropriate.
More information about the PROTECT
trial can be found on ClinicalTrials.gov
under the identifier
NCT05476497.
This announcement contains inside information for the purposes
of Article 7 of the UK Market Abuse Regulations.
- ENDS -
For
further information, please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive
Officer
Shaun Furlong, Chief Financial
Officer
+44 (0)1903 845 820
Panmure Gordon (Nominated Adviser and
Broker)
Emma Earl, Freddy Crossley, Mark
Rogers, Corporate Finance
Rupert Dearden, Corporate
Broking
+44 (0)20 7886 2500
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. Its broad pipeline of products in clinical development
includes vaccines for grass, tree, house dust mite and peanut. For
more information, please see www.allergytherapeutics.com.