TIDMAGY
RNS Number : 3254H
Allergy Therapeutics PLC
03 August 2021
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
Allergy Therapeutics announces successful primary outcome of VLP
Peanut 001; a study evaluating biomarkers from peanut allergic
patients
- Study results confirm peanut vaccine candidate's hypoallergic potential
- Findings support VLP Peanut first in-human Phase I study design, on track to start Q1 2022
- Short-course peanut allergy vaccine candidate represents a
significant opportunity in $8 billion worldwide food allergy
market
- Results strengthen Phase I study IND application being submitted to US FDA in late 2021
03 August 2021 Allergy Therapeutics (AIM: AGY), the fully
integrated commercial biotechnology pharmaceutical company
specialising in allergy vaccines, today announces positive primary
results from an ex-vivo biomarker study evaluating the Group's
novel virus-like particle (VLP) based peanut allergy vaccine
candidate ("VLP Peanut").
The study, which took place at Imperial College London,
evaluated the Group's short-course VLP Peanut and aimed to
demonstrate the vaccine candidate's hypoallergic potential. If a
vaccine is hypoallergenic, it means it does not illicit an allergic
reaction in patients upon dosing. The study used blood samples from
peanut allergy patients to evaluate an extensive set of functional
and molecular biomarkers. This resulted in a successful primary
outcome, with the trial demonstrating a significant 24-fold
reduction in basophil activation and histamine release after blood
samples were challenged with VLP Peanut compared to a recombinant
peanut extract, signifying the hypoallergenic potential of the
vaccine candidate. These positive clinical data add to the Group's
strong pre-clinical research package, which has demonstrated
sustained immunologic protection following peanut exposure after
just one single vaccination.
The biomarker study results are encouraging and provide strong
support for the human translation of the pre-clinical results and
strong confidence in the data to be generated in the planned Phase
I study (the PROTECT study). The data also provide important
information to establish the starting dose for PROTECT, which is
expected to commence in Q1 2022.
Moreover, the results from this study further strengthen the
Group's Investigational New Drug (IND) application with the United
States Food and Drug Administration (FDA), which is expected to be
submitted in late 2021. Further data will be released in due course
once secondary endpoints of the study have been analysed.
In addition, the Group has also recently completed an extensive
multiple dose toxicology study with VLP Peanut, applying the
maximum subcutaneous doses expected to be administered in clinical
trials, which further supports the dose escalations planned in the
first in-human Phase I study. More information on VLP Peanut will
be provided by the Group at a Key Opinion Leader investor event,
currently planned for September 2021.
VLP Peanut is being developed as a novel VLP-based therapy for
the treatment of peanut allergy. This novel immunogenic,
protective, and non-reactogenic vaccine candidate is based on
immunologically optimised Cucumber Mosaic Virus-derived VLPs
(CuMVTT) with the major peanut allergen (Arachis hypogaea) (Ara h
2) displayed on its surface. Patents behind the technology to treat
peanut allergy with VLP Peanut have now been granted in the US and
are at the national phase in other territories.
The potential of an effective short-course peanut allergy
vaccine represents a significant opportunity in the $8 billion
worldwide food allergy market(1) . Peanut allergy is one of the
most common types of food allergy and its symptoms can range from
mild to severe and life-threatening. In the western world, the
prevalence of peanut allergy doubled between 2005 and 2015 and it
is becoming apparent in Africa and Asia(2) . Only about 20% of
children diagnosed with peanut allergy outgrow it by the time they
reach school age. In the US (as of 2014), peanut allergy was the
most common cause of severe and fatal food-induced anaphylactic
reactions(3) .
Manuel Llobet, CEO of Allergy Therapeutics , stated: "We are
pleased to have reached this important milestone in the development
of our ground-breaking and disruptive vaccine candidate, VLP
Peanut. Through our collaboration with Imperial College London and
the dedication of our clinical and R&D teams at Allergy
Therapeutics, we are another step closer to offering a potentially
transformative treatment option for one of the most dangerous
allergies. I am proud of the work we do in helping to transform
patients' lives and look forward to our upcoming IND submission at
the end of this year and expected initiation of our Phase I PROTECT
trial in 2022."
This announcement contains inside information for the purposes
of Article 7 of Regulatory (EU) No596/2014.
- ENDS -
References
1. The Journal of Allergy and Clinical Immunology 2016. 1% of US
population. EACCI Food Allergy and Anaphylaxis Guidelines Group
2016 0.2% of Western European Population. Management assumption of
annual treatment of $2k
2. Du Toit G, Roberts G, Sayre PH, et al. Randomized trial of
peanut consumption in infants at risk for peanut allergy [published
correction appears in N Engl J Med. 2016 Jul 28;375(4):398]. N Engl
J Med. 2015;372(9):803 -- 813.
3. Sampson H, Shreffler W, Yang W, Sussman G, Brown-Whitehorn T,
Nadeau K et al. Effect of Varying Doses of Epicutaneous
Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure
Among Patients With Peanut Sensitivity. JAMA. 2017; 318
(18):1798.
For further information, please contact:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
Panmure Gordon
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Rupert Dearden, Corporate Broking
Consilium Strategic Communications
+44 (0) 20 3709 5700
Mary-Jane Elliott / David Daley / Carina Jurs
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial
biotechnology company 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 and house
dust mite, and peanut allergy vaccine in pre-clinical development.
Adjuvant systems to boost performance of vaccines outside allergy
are also in development.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics
is headquartered in Worthing, UK with more than 11,000m(2) of
state-of-the-art MHRA-approved manufacturing facilities and
laboratories. The Group, which has achieved over 9% compound annual
growth since formation, employs c.600 employees and is listed on
the London Stock Exchange (AIM:AGY). For more information, please
see www.allergytherapeutics.com .
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