Allergy Therapeutics plc (LON:AGY) is a UK-based, specialty pharmaceutical company focused on the development, manufacture and sale of vaccines and other products for the treatment and prevention of allergies. This morning AGY announced that it has obtained approval in Spain for its Clinical Trial Application (CTA) to advance its next generation house dust mite (HDM) vaccine candidate, Acarovac MPL, into phase I clinical development. This vaccine addresses a significant market for allergy sufferers estimated to be worth $1.5 billion annually. As with the recent news that the company is progressing its peanut allergy vaccine, this HDM vaccine further broadens AGY’s vaccine portfolio beyond the seasonal allergies to include this common perennial allergy. Our risk-adjusted fair value estimate remains at 69p per share.
Acarovac MPL (or Acarovac Quattro) is a next generation HDM vaccine candidate based on AGY’s existing Acarovac Plus vaccine, its fastest growing named-patient-product in Spain. In 2015 the company reported excellent results from a 1-year trial of Acarovac Plus which reduced symptom scores by over 50% during follow-up visits after one year of use of the product. Like AGY’s seasonal vaccines, Acarovac Plus is an allergoid-based product which incorporates MCT (microcrystalline tyrosine) to provide a natural, biodegradable depot effect for the vaccine. It typically requires fewer injections than standard HDM desensitisation programmes and maintenance doses are given every 6-8 weeks.
Acarovac MPL represents an enhancement to Acarovac Plus based on the addition of the company’s adjuvant, MPL, a key component of its Pollinex® Quattro range of vaccines. This will be the first HDM vaccine to incorporate an adjuvant like MPL. With both MCT and MPL, AGY aims to deliver to HDM allergic patients the same benefits in terms of safety and efficacy which are currently available to seasonal allergy sufferers using the Pollinex Quattro® range. We believe this could translate into strong and safe HDM vaccine responses induced in an ultra-short vaccine format which should improve tolerability and patient compliance.
As the CTA approval has now been granted for Acarovac MPL, this phase I trial is expected to start immediately. The trial will enrol 32 patients, it will run for 1 year, and two different dosing regimens will be evaluated. Both regimens will include an up-dosing phase (over 2 – 4 weeks) but will differ in the duration of the maintenance phase.
Comment: With this news AGY is further broadening its Quattro®-based product portfolio to address a common perennial allergy, HDM, one of the major causes of allergic rhinitis and allergic asthma. The potential improvement to efficacy and compliance delivered by an enhanced Acarovac vaccine (with MPL) promises to build further on the market position established with Acarovac Plus. We believe there is a strong rationale for a Quattro-type HDM vaccine based on reducing the number and frequency of maintenance injections and we look forward to seeing the results of this Acarovac MPL phase I trial early next year. Assuming positive results through its extended clinical development (including phase III trials) and full regulatory approvals, we believe such a product could potentially generate sales in the USA and Europe exceeding $500m annually by 2030. For the moment our risk-adjusted fair value estimate remains 69p.
Commenting on the CTA approval, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics plc, said: “By using the successful biodegradable adjuvant system of MCT® and MPL, integral in our seasonal marketed vaccines, in a perennial house dust mite vaccine, we aim to improve both safety and efficacy for the thousands of patients who suffer year-round due to house dust mite allergy. Acarovac Quattro will provide convenience to our patients and doctors and more efficient pharmacoeconomics. Effectively, the dosing regime in Acarovac Quattro has the potential to improve the convenience, adherence and compliance that is essential for a successful treatment, and builds on the acceptance of the existing Acarovac Plus platform.”