REG - Allergy Therapeutics - Progression of patient cohorts in PROTECT Trial

Allergy TherapeuticsAnnouncement

17/09/2024 07:00

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RNS Number : 3864E  Allergy Therapeutics PLC  17 September 2024

 

 

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Group")

 

Allergy Therapeutics announces further advancement through patient cohorts in
Phase I/IIa VLP Peanut PROTECT Trial

 

·      Second cohort of peanut allergic patients have completed dosing
with up to 50-fold dose increase from initial dose

·      No relevant safety or tolerability findings observed in either
peanut allergic patients or healthy subjects at higher doses

·      Dose escalation to proceed in next cohorts

·      Preliminary biomarker analysis of efficacy expected by end of
2024

 

17 September 2024 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, today
announces further progress in its Phase I/IIa VLP Peanut PROTECT trial,
building on the positive developments reported
(https://ir.q4europe.com/solutions/allergytherapeutics2018tf/3856/newsArticle.aspx?storyid=16125165)
in June 2024.

 

The second cohort of peanut allergic patients has now completed dosing, with
patients receiving up to a 50-fold dose increase from the initial dose. No
relevant safety or tolerability issues were observed at these higher doses.

 

As announced in June 2024, 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.

 

As a result of these positive safety outcomes, the trial's external safety
review committee has agreed that the doses administered so far have been safe
and well tolerated. Based on this assessment, the committee has approved the
progression to higher doses in cohort 3 for peanut allergic patients and
cohort 4 for healthy volunteers. Final cohorts 3 and 4 are on schedule to
complete dosing in H1 2025.

 

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. Blood
samples taken from peanut allergic study volunteers before and after dosing in
the first two cohorts are being analysed to identify key biomarker changes
indicative of efficacy.

 

The preliminary results from the first two cohorts of peanut allergic patients
assessing safety and efficacy are expected in Q4 2024.

 

Blood samples taken from peanut allergic study volunteers before and after
dosing in cohorts 1 and 2 are being analysed to identify key biomarker changes
indicative of efficacy. Basophil activation testing (BAT) mimics an allergic
reaction by stimulating basophils with peanut allergens and then observing the
expression of activation markers on the surface of the basophils. A reduction
in the expression of those markers in the volunteers' samples would be
indicative of efficacy in the VLP Peanut vaccine candidate. The preliminary
results from the first two cohorts of peanut allergic patients are expected in
Q4 2024.

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "We
are very grateful to both the trial participants and our partner clinicians
for helping Allergy Therapeutics progress VLP Peanut through the clinic.
Peanut allergy remains a disease of high unmet need and patients and their
families are eager to see progress towards solutions. The data gathered
through the PROTECT trial continues to be encouraging, as is the safety review
committee's decision to proceed with higher doses in subsequent cohorts. We
are keen to present preliminary efficacy data based upon biomarkers by the end
of this year."

 

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)
.

 

 

 

- 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
(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. For more information,
please see www.allergytherapeutics.com (http://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.

 

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