Allergy Therapeutics Plc (LON:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announced today that the recruitment of the first patient in its Phase III study designed to evaluate the efficacy and safety of its ultra-short course, aluminium-free Pollinex® Quattro Birch immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.
The first patient in the B301 Phase III study was recruited in Austria on 15 March. The study is anticipated to run for one year and involve more than 550 patients over 50 sites across Germany, Sweden, Austria and Poland. The primary objective of this study is to evaluate the efficacy of Pollinex® Quattro Birch in birch pollen-induced rhinoconjunctivitis and to enable registration of the product in Germany via the Therapieallergene-Verordnung (TAV) process of the Paul Ehrlich Institut, before anticipated marketing authorisation in 2019.
The adopted cumulative dose has been demonstrated to be efficacious in two recent dose range finding studies with respect to reduction of symptoms induced by a conjunctival provocation test (CPT) with no prior safety concerns.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics plc, said: “The start of our Phase III trial investigating Pollinex Quattro Birch marks the beginning of a number of trials aimed at strengthening our product portfolio across Europe and helping the 6% of Europeans who test positive to birch allergens. If approved, Pollinex Quattro Birch will be the first MPL adjuvanted ultra-short course aluminium-free vaccine ever approved. Combined with our clinical programme in the US focusing on Pollinex Quattro Grass, we aim to have a comprehensive global modified allergen + MCT® and MPL vaccine package that focuses on delivering convenience, safety, efficacy and enhanced patient compliance.”
Zeus Capital said that this morning AGY announced that it has initiated B301, the phase III clinical trial of its Pollinex Quattro® – Birch vaccine (PQ-Birch), with the recruitment of the first patient into the study. A total of 550 patients are expected to be recruited and treated across more than 50 sites in northern Europe including Germany, Austria, Sweden and Poland. Assuming a positive outcome for B301, we believe that in 2018 the company will be able to submit an application for marketing authorisation under the TAV to the German biologics medicines regulator, the Paul Ehrlich Institute. Germany is the biggest single European market for allergy vaccines and such a submission could see a marketing authorisation granted in 2019. Our risk-adjusted fair value estimate remains at 69p per share.
The cumulative dose of vaccine being used in B301 was established to be safe and efficacious in two prior dose-finding trials including a large phase IIb trial, B204 (double-blind, placebo-controlled, multi-centre), in which 371 patients were randomised into 6 dosing groups plus a placebo group. Dosing ranged from a cumulative 5,000 standardised units (SU) up to 27,300 SU. The main measure of efficacy was total symptom score following a conjunctival provocation test. B204 demonstrated a statistically significant dose-response from 5,000 to 27,300 SU (p<0.01). There were no dose-related adverse reactions giving us confidence that three essential components of PQ-Birch: the modified Birch pollen allergoid, the MCT, and the MPL, can be used safely at the higher doses.
Comment: While the finer details of this trial have not been disclosed, we anticipate that it will evaluate efficacy through the pollen season on the basis of combined symptom and rescue medication scores (CSMS), as seen in other trials of vaccines for seasonal allergic rhinitis. Given the optimised dosing of the PQ-Birch vaccine, the composition of actives in the PQ platform, and real-world experience of its use as a named-patient product, we are confident that the company is best placed to achieve a successful outcome in B301. The birch pollen season in Europe runs from March to mid-May (polleninfo.org), so we believe that if AGY completes B301 within one year as indicated, then it could be in a position to report headline results from the trial in Q3 2018.
Birch pollen allergy affects over 12m people in Europe with many of these being severe enough to be considered for allergy immunotherapy. We estimate sales for an effective Birch pollen allergy vaccine could reach over $100m at peak in Europe alone. Our risk-adjusted fair value estimate remains 69p.