Allergy Therapeutics
plc
("Allergy
Therapeutics" or "the Group")
Allergy Therapeutics
announces progression through patient cohorts in Phase I/IIa VLP
Peanut PROTECT Trial
- First cohort of peanut
allergic patients in Phase I/IIa VLP Peanut PROTECT trial completes
subcutaneous dosing with three incremental dose increases and no
relevant safety or tolerability findings
- Third cohort of healthy
subjects completes dosing without relevant safety or tolerability
issues representing a 400-fold dose increase from the first dose
administered
- Preparations underway for
PROTECT trial to progress to last cohort in healthy subjects and
dose escalation to similar high strengths in peanut allergic
patients with biomarker analysis of efficacy
included
10
June 2024 Allergy Therapeutics (AIM:
AGY), the fully integrated commercial biotechnology company
specialising in allergy vaccines, today announces completion of new
cohorts of healthy subjects and peanut allergic patients who have
received increasing dose strengths of its novel virus-like particle
(VLP)-based peanut allergy vaccine candidate ("VLP
Peanut").
A
next-generation peanut allergy immunotherapy
The ongoing Phase I/IIa VLP Peanut
PROTECT trial is evaluating the maximum safe and tolerated dose of
the Group's peanut allergy vaccine candidate and includes
assessment of biomarker efficacy in peanut allergic
patients.
Patients who are allergic to peanuts
had previously completed skin-prick testing in the PROTECT trial
and, following the announcement on 12 March 2024 that the first
peanut allergic patient had received subcutaneous dosing of the
candidate vaccine, that patient cohort has now completed three
incremental dose levels over 2 months with no safety signals
observed.
Healthy subjects in the PROTECT
trial have now received a 400-fold dose increase of VLP Peanut,
providing strong confidence that the VLP technology within the
vaccine candidate is safe and well tolerated at high cumulative
doses. This is essential for further clinical development of VLP
Peanut as the external safety review committee agreed that the
doses administered so far have been safe and well tolerated and
dose increments in next cohorts can proceed as planned to similarly
high doses in peanut allergic patients and to establish the dose
range to be considered for the upcoming Phase IIb study.
Manuel Llobet, Chief Executive Officer of Allergy
Therapeutics, commented: "The promising safety and
tolerability data from the latest cohorts in the PROTECT trial of
our peanut allergy vaccine candidate are welcomed, providing a
solid basis for the design of our upcoming Phase IIb study. Ahead
of that, the PROTECT trial continues apace as we look to generate
the first biomarker-led efficacy data, among higher-dose peanut
allergic patients in the next cohorts of the
trial."
More information about the PROTECT
trial can be found on ClinicalTrials.gov
under the identifier
NCT05476497.
- 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. 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.