Allergy Therapeutics PLC Positive top line phase I results for Acarovac MPL (4837Z)
May 20 2019 - 1:00AM
UK Regulatory
TIDMAGY
RNS Number : 4837Z
Allergy Therapeutics PLC
20 May 2019
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
Allergy Therapeutics announces positive top line results from
Phase I clinical study using Acarovac MPL
- Investigational house dust mite allergy vaccine demonstrates
good safety and tolerability profile
- Patients experienced symptom improvement in response to Nasal
Provocation Testing
20 May 2019 Allergy Therapeutics plc (AIM: AGY), the fully
integrated commercial biotechnology company specialising in allergy
vaccines, today announces positive Phase I safety and tolerability
results of subcutaneous Acarovac MPL (Monophosphoryl Lipid A) in
patients with house dust mite (HDM)-induced allergic
rhinoconjunctivitis. The AM101 trial was an open-label study to
assess the safety and tolerability of Acarovac MPL in 16 adult
patients with house dust mite-mediated allergic
rhinoconjunctivitis.
The primary endpoint was the safety and tolerability of 7
injections of Acarovac MPL administered over 6-12 weeks each 1-2
weeks apart. The formulation was well tolerated. The safety profile
was satisfactory and the reported adverse events were consistent
with what have been observed with similar formulations of allergy
vaccines.
Secondary endpoints included the effect of treatment on response
to nasal provocation test (NPT), immunological parameters including
immunoglobulins and patients' satisfaction with the treatment. A
significant improvement from baseline in patients' total symptom
scores following NPT after 12 weeks, and significant increases in
immunoglobulin markers and reduction in IL-4 were observed.
Patients reported high satisfaction with their treatment measured
via the ESPIA questionnaire (Satisfaction Scale for Patients
Receiving Allergen Immunotherapy).
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
said: "The success of our clinical trial in house dust mite-induced
allergic rhinitis is encouraging news for the many patients who
continue to suffer with the symptoms caused by house dust mite
allergy, and supports our ambition to provide a global therapy for
the important US, China and EU markets. Based on the unique
triple-combination of our allergoids, and the adjuvant system MPL
and MCT we believe Acarovac MPL could build on our success in dust
mite immunotherapy and we look forward to progressing towards phase
II clinical studies."
Acarovac MPL is a subcutaneous immunotherapy product containing
Dermatophagoides pteronyssinus and Dermatophagoides farinae
allergoids adsorbed to the adjuvant system comprised of MCT(R)
(Microcrystalline Tyrosine) and MPL.
- ENDS -
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
Erik Anderson, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia
Manser
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
Notes for editors:
About Acarovac MPL
House dust mite is the major cause of perennial allergic
rhinitis and allergic asthma([1]) . Acarovac MPL builds on the
strong foundation of technologies employed in the successful
Pollinex Quattro range of allergy immunotherapies. It is the only
house-dust mite immunotherapy utilising the adjuvant system
comprised of MCT(R) (Microcrystalline Tyrosine), a natural,
biodegradable depot, and the adjuvant MPL for the treatment of
perennial allergic rhinitis which makes this vaccine unique in the
$1.5 billion per year market ([2]) .
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 include vaccines for grass, tree and house
dust mite, and peanut allergy vaccine in pre-clinical development.
Other 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 double digit compound
annual growth since formation, employs c.500 employees and is
listed on the London Stock Exchange (AIM:AGY). For more
information, please see www.allergytherapeutics.com.
References:
[1] Calderón M et al., Respiratory allergy caused by house dust
mites: What do we really know? J Allergy Clin Immunol. 2015
Jul;136(1):38-48
[2] QYR Pharma report. September 2016
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END
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