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

– Optimal Phase III dose identified –

Phase III study due to commence in 2019 –

May 21, 2018 I 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.”

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

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including 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. 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 11,000m2 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.

About Grass MATA MPL

Grass MATA MPL contains three distinct components: allergoids, micro-crystalline tyrosine (MCT) and monophosphoryl lipid A (MPL®). Allergoids (natural allergens chemically modified to form allergoids) exhibit reduced allergenicity that improves safety and allows for delivery of higher doses. These are combined with the depot adjuvant technology MCT to provide enhanced immune exposure and further improved tolerability.

Finally, the immune response is enhanced and directed by the adjuvant MPL®. MPL is a toll-like 4 receptor (TLR4) agonist which has been extensively used in the Group’s other allergy vaccines available on the market and in vaccines registered in the USA.

If approved, the product will be the first registered subcutaneous immunotherapy product in the US for grass allergy.

About US allergy market

The US allergy immunotherapy market, which is anticipated to be the main market for this product, is estimated by the Group to be worth $2 billion with potential peak grass vaccine sales of $300-400 million per annum.

  • European Academy of Allergy and Clinical Immunology (EAACI) Global Atlas of Allergy. 2014.

SOURCE: Allergy Therapeutics