RCS - Allergy Therapeutics - VLP Peanut PROTECT Trial Update

Allergy TherapeuticsAnnouncement

12/03/2024 07:15

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RNS Number : 4249G  Allergy Therapeutics PLC  12 March 2024

 

 

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
(https://clinicaltrials.gov/ct2/home) under the identifier NCT05476497
(https://clinicaltrials.gov/ct2/show/NCT05476497?term=NCT05476497&draw=2&rank=1)
.

 

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
(mailto: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
(http://www.allergytherapeutics.com) .

 

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