Allergy Therapeutics PLC US Phase II study for GrassMATAMPL initiated
December 07 2015 - 02:00AM
RNS Non-Regulatory
TIDMAGY
Allergy Therapeutics PLC
07 December 2015
7 December 2015
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
US Phase II study for GrassMATAMPL initiated
Headline data expected Q2 2016; US clinical development plans on
track
Allergy Therapeutics, the fully integrated specialty
pharmaceutical company specialising in allergy vaccines, today
announces enrolment of the first ten US patients in the Company's
GrassMATAMPL ("GMM") 204 phase II study (G204). G204 is a
double-blind, placebo-controlled cumulative dose selection study
for grass allergic rhinitis, which follows the successful
completion of the GMM102 (G102) safety study, which demonstrated
safety of two new doses of GMM and supports the further testing of
efficacy in the current G204 study. The G204 phase II study has
been agreed with the FDA, is expected to read out in the second
quarter of 2016, and precedes the initiation of the pivotal phase
III study for US approval.
GMM is developed from Allergy Therapeutics' successfully
marketed Pollinex Quattro Grass product, which has been available
in Europe for a number of years treating circa 250,000 patients(1)
, and is designed to provide a uniquely ultra-short course of
injections to prevent seasonal grass allergy. Grass allergy occurs
in up to 50% of the US population(2) of those suffering from
seasonal allergic rhinitis/conjunctivitis, and is often poorly
controlled by anti-leukotrienes and nasal corticosteroids.
Manuel Llobet, CEO of Allergy Therapeutics, said: "The US
clinical development programme for our ultra-short course,
aluminium-free allergy vaccine for grass remains on track. We
continue to expect to file for US approval at the end of 2018. The
US allergy immunotherapy market has historically been serviced by
subcutaneous rather than sublingual compounded vaccines. We are
therefore confident that the availability of an FDA-approved
subcutaneous vaccine, which we are striving to achieve, will
facilitate a fast penetration and broad acceptance of the product
among the prescriber base."
References
1 Allergy Therapeutics Data
2 DataMonitor Epidemiology - Epidemiology Allergic Rhinitis
-March 2011
For further information:
+44 (0) 1903 845
Allergy Therapeutics 820
Manuel Llobet, Chief Executive Officer
Ian Postlethwaite, Finance Director
+44 (0) 20 7886
Panmure Gordon 2500
Freddy Crossley / Peter Steel / Duncan Monteith,
Corporate Finance
Tom Salvesen, Corporate Broking
+44 (0) 20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Mo Noonan
Note to editors:
About Allergy Therapeutics
Allergy Therapeutics is a specialty pharmaceutical company
focused on allergy vaccination. It has a growing business achieving
revenue in the last financial year of GBP43 million mainly in
Europe through its own sales and marketing infrastructure and
further afield through distributors.
About Pollinex Quattro
Pollinex Quattro is a unique allergen-specific immunotherapy
that comprises three key technologies tailored to reduce irritation
and systemic reactions; modified allergens, microcrystalline
tyrosine (MCT) and Monophosphoryl lipid A (MPL).
The ultra-short duration of Pollinex Quattro is achieved via
allergen modification that transforms the structure of allergens to
allow increased doses to be delivered compared to traditional
unmodified preparations. The potent depot adjuvant, MCT, has a Th1
immunomodulating action that acts in synergy with the TLR4 receptor
agonist MPL to augment a shift in the immune reactions responsible
for the symptoms of allergic rhinitis.
The study G204
The G204 study is the first to use multiple mobile Environmental
Exposure Chambers providing constant pollen exposure to allergic
patients, which is ideal for dose selection studies. The chambers
are located in Cincinnati and New Jersey where 250 patients in
total will be studied before and after treatment.
The first patients have successfully completed the screening
phase of the study and were randomised to treatment on the 1
December 2015.
A safety study G102 had been completed on the 20(th) of October
and no significant adverse events were reported with the new dose
regimens that are being used in G204.
This information is provided by RNS
The company news service from the London Stock Exchange
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