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 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
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
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
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.