Mission Statement
To create a sustainable, fast-growing and profitable global speciality pharmaceutical business with a substantial franchise in the allergy sector by developing innovative, patented, registered therapies for both the treatment and prevention of allergy-related conditions.

NEWS

19th Jul 2018 Proposed placing and subscription to raise up to £10.6 million
13th Jul 2018 Hardman & Co Research
12th Jul 2018 Trading update
25th Jun 2018 Positive data of Pollinex Quattro Grass vaccine
29th May 2018 Positive data with house-dust mite immunotherapy
21st May 2018 Positive top-line results from Grass Ph II study
14th May 2018 Publication of MCT Adjuvant Data
07th Mar 2018 Hardman Research: Clinical development towards submission
07th Mar 2018 Interim Results for the six months ended 31 December 2017


VIDEO/AUDIO
21st May 2018 Allergy Therapeutics on track for phase III grass pollen trial in 2019
September 2017 5 minute pitch
09th May 2016 Allergy Therapeutics boss excited by PQBirch204 Phase II data
08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable
18th Feb 2016 Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019
14th Jan 2016 Allergy Therapeutics boss says the firm is outperforming its competitors

EVENTS
27 11 2018 AGM (tentative)
03 10 2018 Shares Investor Evening (London)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)


WEBSITES

21 November 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Block Listing Application

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that an application has been made to the London Stock Exchange for admission to AIM for a block listing of 10,000,000 ordinary shares of 0.1p each in the Company ("Ordinary Shares").

The new Ordinary Shares will not be allotted immediately but rather will be issued and allotted from time to time pursuant to the exercise of employee options under the Allergy Therapeutics 2013 Long Term Incentive Plan. On exercise, these new Ordinary Shares will be issued as fully paid and will rank pari passu in all respects with the existing Ordinary Shares of the Company.

The expected effective date of admission of these securities to AIM is on or around 24 November 2017.

http://www.moneyam.com/action/news/showArticle?id=5750700

12 December 2017
Allergy Therapeutics plc

Allergy Therapeutics enters co-development agreement with Ergomed plc

12 December 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces it has entered into a co-development collaboration agreement with Ergomed plc ("Ergomed") (AIM:ERGO) for the clinical development of three OralVac immunotherapy products. Allergy Therapeutics' core focus remains the convenient short course subcutaneous immunotherapy (SCIT) products, with the OralVac sublingual products providing an alternative option for patients who prefer oral products.

To capitalise on the changing regulatory requirements in Germany, the OralVac products, which are currently sold in Europe on a named patient basis, are being registered under the new TAV (Therapieallergene-Verordnung) regulation programme managed by the Paul Ehrlich Institute in Germany. The pharmaceutical development and pre-clinical evaluation for these products has already been completed by Allergy Therapeutics.

This planned OralVac clinical development expands Allergy Therapeutics' current broad SCIT clinical programme. To manage this expansion, Simon Piggott, Head of Clinical Sciences and Denise Lee, Head of Clinical Operations will lead early and late phase EU clinical development respectively, with Pieter-Jan de Kam, Clinical Director, to lead the US clinical development programme, which is focused on SCIT products and is a key part of the Group's three-pillar growth strategy.

Under the terms of the agreement, Ergomed will progress the clinical development of OralVac products for the treatment of grass pollen, tree pollen, and house dust mite allergies. The collaboration includes a future revenue share and reduced service fee.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "We are pleased to announce this co-development programme with Ergomed, which is aimed at strengthening our product portfolio across Europe in a risk-sharing fashion. Ergomed has over 20 years of experience in clinical development and significant expertise in the allergy field, and are thus ideally placed to support us in the progression of our OralVac products."

http://www.moneyam.com/action/news/showArticle?id=5777145

09 January 2018
Allergy Therapeutics plc

PQ Birch Phase III clinical trial completes recruitment

9 January 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that recruitment of the Group's Phase III clinical trial with PQ Birch (PQBirch301) has been completed as expected. The PQBirch301 study is a pivotal Phase III study designed to evaluate the safety and efficacy of the Group's ultra-short course, convenient for patients, aluminium free PQ Birch subcutaneous immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.

The PQBirch301 study has randomised over 560 patients from 59 centres in four European countries: Germany, Austria, Poland and Sweden. The primary efficacy data will be assessed during the birch pollen season of 2018 and the results of the trial are expected during H2 2018. The successful completion of this pivotal Phase III study would fulfil the requirements for PQ Birch under the Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institut before anticipated marketing authorisation.

PQ Birch is one of a number of ultra-short course, subcutaneous immunotherapy products in clinical development for various allergies, and these form a key component of the Group's three-pillar growth strategy. This includes: developing a strong pipeline facilitated by investment from the growing, profitable European revenue stream; expanding the existing European business; and preparing for product entry into the US market. The PQ family of products complement the Group's existing European marketed portfolio of convenient short course subcutaneous immunotherapy products and are particularly suited to the changing regulatory environment for allergy products in the US


Approximately 6% of the population of Europe alone is allergic to birch pollen1 and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The completion of recruitment in our pivotal Phase III clinical study with PQ Birch is an important milestone for the Group. Marketing authorisation of the first MPL-adjuvanted, ultra-short course aluminium free vaccine available to patients will strengthen the Group's portfolio and help address the current unmet needs in allergy."

1 DataMonitor Epidemiology Report. 2011

http://www.moneyam.com/action/news/showArticle?id=5807728

31 January 2018
Allergy Therapeutics plc

Trading Update

Market share gains driving top line growth

Strong cash position sustained by good performance.

31 January 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today provides a trading update for the six months ended 31 December 2017, ahead of its unaudited interim results to be announced on 7 March 2018.


Financials

The Group reports that it is trading in line with the Board's expectations. Reported revenues for the six months ended 31 December 2017 are expected to be £42.2m (2016: £40.4m), representing 4.4% growth on a reported basis and 1.3% growth at constant currency. The Group has continued to grow in the past six months of 2017, notwithstanding an abnormally weak pollen season in Central Europe1, outperforming the market by an average of 4 percentage points2 thanks to focused sales and marketing strategy and its exclusive technology platform. In Germany, the Group's market share has risen by one percentage point to 14% over the past twelve months on a moving annual average basis. The fastest growing operations for the Group in the six months ended 31 December 2017 were the Spanish subsidiary as well as the Emerging Markets segment.

By leveraging additional revenues on current infrastructure, the Group continues to improve its operational margins pre-R&D. This, along with careful planning of working capital and capex investments, has allowed the Group to maintain a strong cash position of £25.8m (31 December 2016: £27.8m).


Products

There continues to be increasing uptake of the Group's portfolio of convenient and patient-friendly treatments. Pre-seasonal ultrashort course aluminium free vaccine Pollinex Quattro, designed to address the cause of symptoms of patients sensitised to seasonal allergens (grass, trees, ragweed), remains a key growth driver for Allergy Therapeutics based on the benefits of the Group's treatment programs.

Venomil, the Group's product that treats the life threatening condition of venom allergy, grew strongly as well as Acarovac Plus3 which continued to outperform the rest of the portfolio in Spain.


Pipeline

The Group's Phase III PQ Birch trial has recently completed recruitment, with results expected in H2 2018. The successful completion of this pivotal Phase III study would fulfil the requirements for PQ Birch under the Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institute before anticipated marketing authorisation.

The PQ Grass Phase II trial continues to recruit on schedule with results also expected in H2 2018. Following completion of this trial, meetings with the regulatory authorities in the US and Germany will be necessary to enable Phase III trial design.

Additionally, all the German TAV plans are on track with the recent incorporation of the clinical development programmes for the oral vaccine Oralvac, under a co- development agreement with Ergomed announced in December 2017.


Outlook

Post the period end current trading remains positive and the Board remains confident in the outlook for the business for the remainder of the year. Allergy Therapeutics' competitive position continues to improve with increased market share, in the countries in which it operates, increasing in line with its long term plans to achieve 20% market share. Market share gains are consistent across its key European markets, notably in highly competitive markets like Spain, Germany, Austria and Holland.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "Our strategy to prioritise patient friendly vaccines with focus on patient compliance and improving adherence rates is demonstrating success. Our portfolio of ultra-short course vaccines is driving our market penetration in Europe and preparing the ground for a successful US entry. All our key development programmes are being executed according to plan and our long-term strategic objectives, are on track. We feel privileged to keep developing Allergy Therapeutics as we satisfy the significant unmet needs of our patients."

http://www.moneyam.com/action/news/showArticle?id=5836625

02 February 2018

Hardman Research: Growth in a tough market

Growth in a tough market: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) grass, the subcutaneous allergy immunotherapy (AIT), continues to gain market share despite being available in the EU only on a 'Named Patient' basis. Trials designed to obtain regulatory approval for PQ approved as a biologic in both Europe and the US are well advanced. Meanwhile, although underlying sales growth was weaker than expected in 1H'18, this was on the back of an unusually shorter and lower pollen season in central Europe, suggesting that AGY has continued to make further market share gains.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/02.02.18-growth-in-a-tough-market.pdf

http://www.moneyam.com/action/news/showArticle?id=5840974

Allergy Therapeutics plc

Completion of recruitment in PQ Grass Phase II trial

Trial running ahead of schedule with data now due in early H2 2018


12 February 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that recruitment has been completed in its grass allergy Phase II study (G205), with results due ahead of expectations in early H2 2018. The trial is designed to evaluate the dose-response and safety of its ultra-short course, aluminium free PQ Grass immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.


The study protocol involves more than 440 patients in over 50 sites across Germany, Austria and Poland. The trial is designed to identify the optimal efficacious cumulative dose using conjunctival provocation testing. This type of challenge testing has recently been used in studies for a similar subcutaneous allergoid MPL product resulting in selection and approval of dose for use in a phase III study.


One of the key markets for this global product is expected to be the US. The US allergy immunotherapy market is estimated by the Group to be worth $2 billion with potential peak grass vaccine sales of $300-400 million per annum. If approved, the product will be the first registered subcutaneous immunotherapy product in the US for allergy.


Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The completion of recruitment for all patients in our Phase II trial is an important step in our journey towards access to the US market in which PQ Grass has the potential to become a convenient, best in class, ultra-short course subcutaneous immunotherapy. We are pleased that the study is running ahead of schedule and look forward to seeing the results later this year."

http://www.moneyam.com/action/news/showArticle?id=5851299

Investor Evening - 7 March - London - Allergy Therapeutics, Bluejay Mining, Healthperm and Mercia Technologies

http://www.moneyam.com/InvestorsRoom/posts.php?tid=20764#lastread

28 February 2018
Allergy Therapeutics plc

Allergy Therapeutics prepares for manufacturing and clinical development of Polyvac® Peanut allergy product


- Specialist CMO AGC Biologics engaged -


28 February 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces it has signed a contract with AGC Biologics (Heidelberg, Germany) to scale up the manufacturing of its Polyvac® Peanut product for use in clinical studies.

Pre-clinical findings using Polyvac® Peanut demonstrated protection against anaphylaxis and induction of protective immunity. It is planned that further development of this product will enable the Group to address the current unmet need. Allergy Therapeutics will now scale-up and validate the manufacturing processes for Polyvac® Peanut as part of the clinical development programme.

Food allergy, and in particular peanut allergy, is a significant and strategically important area for Allergy Therapeutics due to the serious and destabilising effects on the lives of both patients and their families. The global addressable market for therapies to help mitigate these effects is estimated at $8 billion per annum1.

AGC Biologics is a contract manufacturing organisation (CMO) specialising in expression and purification of recombinant therapies. The company has produced batches of cGMP-compliant material for a variety of pharmaceutical and biotech companies with proven operational expertise in the transfer, development, scale-up and validation of cGMP processes and has prior experience in expression of virus like particle constructs.


Manuel Llobet, CEO at Allergy Therapeutics, stated: "The disruption to patients' social and family life as a result of food allergies is significant, and we are committed to addressing these current unmet needs. The Group's peanut vaccine programme complements our current marketed range of ultra-short course vaccines in terms of safety, efficacy and improved patient convenience. We are pleased to start working with AGC Biologics in order to further progress the clinical programme."

http://www.moneyam.com/action/news/showArticle?id=5872398

Unless I made a mistake AGY have changed their tentative Interim Results date from the 8th to the 7th:

07 03 2018 Interim Results 2018 Announcement (tentative)

http://www.allergytherapeutics.com/investor-relations/financial-calendar/


Hmmm, which now ties in with

Investor Evening - 7 March - London - Allergy Therapeutics, Bluejay Mining, Healthperm and Mercia Technologies
http://www.moneyam.com/InvestorsRoom/posts.php?tid=20764#lastread

and te start of the European Drug Safety Summit 2018
http://www.wplgroup.com/aci/event/european-drug-safety-summit/

Just had a quick check on AGY global sites and the Italy one has changed address and has a new look:



The Germany/Austria site has same address but new look:




There is now a Swiss site:

On 1.11.2017 we renamed the company Teomed AG to Bencard AG.

https://bencard.ch/

07 March 2018

Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 0930 GMT today. Dial-in details are: +44 (0) 1452 580733. Conference ID: 2485568.

Allergy Therapeutics plc

Interim Results for the six months ended 31 December 2017


- Consistent performance driven by market share gains

- Pivotal year with Grass MATA MPL readout due in H2 2018

7 March 2018 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces its unaudited interim results for the six months ended 31 December 2017.

Highlights (including post period end highlights)


Financial highlights

· Reported revenue increased by 4.4% to £42.2m (H1 2017: £40.4m) and to £40.9m at constant currency*, representing 1.3%** growth despite an abnormally weak pollen season

· R&D expenditure increased to £5.9m (H1 2017: £3.8m) due to investment in the Grass MATA MPL Phase II and PQ Birch Phase III trials

· 12% growth in pre-R&D operating profit to £12.3m (H1 2017: £11.1m) as a result of broad investment in the business and the strength of the euro against sterling

· Strong cash balance of £25.8m (H1 2017: £27.8m)



Operational highlights

· Increased market share in the German market to 14% (2017: 13%)

· Breadth of portfolio demonstrated by strong performance from Venomil and Acarovac Plus

· Completion of recruitment in the pivotal Pollinex Quattro Birch Phase III study for Europe

· Completion of recruitment ahead of schedule for the Grass MATA MPL Phase II dosing trial for the US

· Contract for scaling up the Polyvac® Peanut product signed with AGC Biologics, aiming for first in human trials in 2019

· Acarovac Phase I trial continues with readout expected in H1 2019

· Contract for joint development of Oralvac products in the TAV process signed with Ergomed

· Bencard Adjuvant Systems continues to build its IP assets with microcrystalline tyrosine manufacturing process patented in key worldwide markets



Commenting on the interim results, Manuel Llobet, Chief Executive Officer, said: "2018 is set to be a pivotal year for Allergy Therapeutics with the key Grass MATA MPL Phase II trial on course for readout in the second half of the calendar year. This could provide us the platform to expand into the lucrative US market. In the first half of this year, we continued to outperform the wider market and delivered an increase in revenue at constant currency despite an abnormally weak pollen season, demonstrating the strength of our differentiated products. This reflects the quality of the Group's highly convenient, ultra-short course, aluminium-free therapy, enabling us to continue to gain market share."

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

* Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements. See table in financial review for an analysis of revenue.

** Percentage based on figures in thousands (2017: £40.956m, 2016: £40.427m)

http://www.moneyam.com/action/news/showArticle?id=5882305

A reminder:

Investor Evening - 7 March - London - Allergy Therapeutics, Bluejay Mining, Healthperm and Mercia Technologies

http://www.moneyam.com/InvestorsRoom/posts.php?tid=20764#lastread

'Pivotal' year ahead for Allergy Therapeutics with key trial readouts (Video)
08:56 07 Mar 2018

Nick Wykeman and Manuel Llobet from Allergy Therapeutics plc (LON:AGY) caught up with Proactive Investors following the release of their interim results.

Allergy's continued to gain market share as it heads into a ‘pivotal’ twelve months.
Interim revenues rose by 4% to £42.2mln despite the pollen season being described as ‘abnormally weak’.

Headline or first glance data from the Phase III Pollinex Quattro Birch study in Europe is expected in the second half of the year along with first results from a Grass MATA MPL Phase II trial.

http://www.proactiveinvestors.co.uk/companies/stocktube/8851/-pivotal-year-ahead-for-allergy-therapeutics-with-key-trial-readouts-8851.html

https://www.youtube.com/watch?time_continue=201&v=ly_tv57J0XI

Allergy Therapeutics Results Video & investor meeting details
7th March 2018 | Allergy Therapeutics plc

Allergy Thereapeutics plc (LON:AGY) this morning released their Interim Results for the 6 months ended 31st December 2017. A short video is available below, with further explainer videos available on their company wall.

They reported a 4.4% increase in revenues, and this was against a backdrop of an unusually weak market: the pollen season was abnormally weak this year, leading to less demand for remedies & vaccinations. Their products Venomil and Acarovac Plus performed very well, and there have been a number of developments in AGY’s clinical trial pipeline.

Allergy Thereapeutics increased their R&D expenditure to £5.9m from £3.8m in the previous half. This was due to investment in their grass and Birch vaccine trials ( Grass MATA MPL Phase II and PQ Birch Phase III trials.

Professional Investors, UK wide meeting details
We are organising UK wide investor meetings with Allergy over the coming year, visiting London, Birmingham, Bristol, Manchester, Leeds, Edinburgh and Glasgow. The meetings are strictly for professional investors, and please contact us if you would like to meet them. We will be releasing dates shortly.

http://fmp-tv.co.uk/2018/03/07/allergy-therapeutics-results-video-investor-meeting-details/

07 March 2018

Hardman Research: Clinical development towards submission

Clinical development towards submission: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) Grass, the subcutaneous allergy immunotherapy (AIT), continues to gain market share despite being available in the EU only on a 'Named Patient' basis. The Phase III trial, designed to obtain approval for PQ Birch as a biologic in Europe, is well advanced, and the Phase II PQ Grass trial will report data shortly. As explained in the February trading update, underlying 1H'18 sales growth, although weaker than expected due to a low pollen season in central Europe, suggests that AGY has continued to make market share gains.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/agy---interims---7th-march-2018.pdf

http://www.moneyam.com/action/news/showArticle?id=5882943

Slides from the Investor Evening - 7 March:


http://s1.moneyam.com/pdfs/20180307-investor-evening/nick-wykeman-allergy-therapeutics.pdf

Video from the Investor Evening - 7 March:

Nick Wykeman, FD - Allergy Therapeutics (AGY)

Shares Magazine
Published on Mar 12, 2018

Allergy Therapeutics (AGY) - Allergy Therapeutics is a Europe-based specialty pharmaceutical company focused upon the diagnosis and treatment of allergy. Allergy Therapeutics has an existing sales base of approximately £40 million per year, an MHRA-approved manufacturing capability as well as an established sales and marketing infrastructure in several major European markets.

https://www.sharesmagazine.co.uk/video/nick-wykeman-fd-allergy-therapeutics-agy

16 March 2018
Allergy Therapeutics plc

Director/PDMR Shareholding

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that, on 15 March 2018, Tunde Otulana, Non-Executive Director of the Company, purchased 25,000 ordinary shares of 0.1p in the Company ("Ordinary Shares") at a price of $0.388 per Ordinary Share (equivalent to 27.8p per Ordinary Share)*. Mr Otulana's total beneficial holding now amounts to 50,000 Ordinary Shares, which represents 0.01% of the issued share capital of the Company to which voting rights are attached.

http://www.moneyam.com/action/news/showArticle?id=5896523

14 May 2018
Allergy Therapeutics plc

Allergy Therapeutics Publishes New Data Validating Mode of Action and Unique Adjuvant Properties of its Patented Adjuvant, Microcrystalline Tyrosine (MCT®), in The Journal of Immunology

Novel Findings Further Highlight the Effectiveness of MCT as Alternative to Alum and its Potential Advantage in Allergy-Specific Immunotherapy

WORTHING, United Kingdom, 14 May 2018 - Allergy Therapeutics (AIM:AGY), a leading, fully-integrated commercial biotechnology company specialising in allergy vaccines, today announces that new data from a study investigating immune responses produced by microcrystalline tyrosine (MCT®)-based vaccines as compared with conventional aluminium hydroxide has been published online in The Journal of Immunology. The findings demonstrate that, based on its comparable strength and mechanism of Ag-specific IgG induction and induction of T cell responses, MCT® is a suitable and flexible alternative to aluminium hydroxide as an adjuvant in both allergen-specific immunotherapy and infectious disease applications. The study also demonstrated that MCT®-adjuvanted allergens caused fewer anaphylactic reactions compared with alum-adjuvanted allergens.

"These findings provide evidence of the effectiveness of MCT as an adjuvant, confirming the mechanism of action underlying its ability to induce a robust and sustained immunological response. Additionally, the findings indicated a potentially favourable profile for the use of MCT over alum in allergy-specific vaccines," said Matthias Kramer, M.D., Allergy Therapeutics' International Medical Director and co-author of the paper. "We believe these data highlight the significance of our differentiated proprietary platform technology in the development of our growing suite of cutting-edge, globally marketed ultra-short course allergy vaccines."


This is the first study to report the mechanism of action by which MCT governs the immunologic response after exposure to an antigen and protection against anaphylaxis in an allergic model. The results illustrate upregulation of IgG antibody responses and a higher IgE:IgG ratio in MCT-based immunotherapy compared with Alum-based immunotherapy. A high IgE:IgG ratio has been reported to be a positive predictive marker for allergen immunotherapy in humans.

Further evaluation in this study indicated that MCT facilitates robust adaptive T cell responses with associated IFN-γ (interferon gamma) and TNF-α (tumour necrosis factor alpha), which is in line with previous studies illustrating protective efficacy in influenza and malaria applications1, 2. Meanwhile, studies in a cancer (melanoma) model are underway.


A link to publication is here: www.jimmunol.org/content/200/9/3151

http://www.moneyam.com/action/news/showArticle?id=5968725

21 May 2018
Allergy Therapeutics plc

Allergy Therapeutics announces positive top-line results from its Grass MATA MPL
Phase II dose ranging study

- Primary endpoint met with highly statistically significant dose-response relationship established -

- Optimal Phase III dose identified -

- Phase III study due to commence in 2019 -



21 May 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces highly positive top-line results from its Grass Modified Allergen Tyrosine Absorbed (MATA) MPL Phase II dose ranging study (G205). The trial met its primary endpoint of establishing a dose-response relationship and a Phase III dose. Approximately 30% of the population in Europe and 25% of the population of the US are allergic to grass pollen1, one of the most prevalent global aeroallergens.



The key results announced today:

· Primary endpoint of the trial met with highly statistically significant dose-response relationship (p<0.0001)

· All dosing regimens were safe and well tolerated

· The currently marketed product showed a significant improvement compared to placebo (p<0.01)

· Significant increase in immunoglobulin results, highly consistent with the dose response observed for the primary endpoint

· Adherence to the short treatment course was excellent. More than 95% of patients received the target cumulative dose during six weekly subcutaneous injections


The G205 trial is a multi-centre, double-blind, placebo controlled study designed to explore the safety and response of different cumulative doses of Grass MATA and MPL for grass-pollen induced seasonal allergic rhinitis. The European study took place in Germany, Poland and Austria and 447 patients were randomised into four active arms plus a placebo, evaluating the change in allergic symptoms as determined by the total symptom score (TSS) following conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.



Manuel Llobet, CEO at Allergy Therapeutics, stated: "We are thrilled with these extremely positive results demonstrating dose dependent efficacy of the product including the current marketed dose. This study represents a major milestone in our path forward to a registered grass allergy product in Europe. Additionally, this brings us closer towards marketing authorisation in the estimated $2bn US allergy market, a significant opportunity where our product has the potential to be the first registered subcutaneous immunotherapy for the treatment of grass allergy. With an optimal dose identified, we look forward to sharing this new, exciting data with the health authorities and plan to commence a Phase III study in 2019.


"Allergy Therapeutics provides the only ultra-short course, aluminium-free treatment containing our MPL adjuvant in the European market, and its convenience for patients is driving market penetration in all our markets."

http://www.moneyam.com/action/news/showArticle?id=5978006