Trinity Delta Start of pivotal Grass MATA MPL Phase III trial

Start of pivotal Grass MATA MPL Phase III trial

Lighthouse | 8 December 2022

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The first subject has been dosed in the pivotal G306 Grass MATA MPL Phase III trial, with the study timed to run over the 2023 hay fever allergy season. Initial top-line data are expected in Q423. The trial will be conducted in the US and Europe at c 120 sites, and will recruit around 1,200 patients, who will receive six injections over 13-weeks.
The G306 trial design has been optimised based on the highly positive G309 exploratory Phase III field trial. In G309, Grass MATA MPL demonstrated a c 40% improvement in the 14-week treatment group in the combined symptom and medication score (CSMS), a measure of daily symptoms and the use of relief medication, averaged over the peak grass pollen season. This magnitude of effect appears larger than that observed in trials for other severe hay fever treatments, for example the GRASTEK grass sublingual tablet achieved a 29% improvement over placebo on a similar measure when taken daily for 24-weeks, with the usual caveat of cross trial comparison limitations.
Assuming data from G306 are positive, these will form the basis of the efficacy element for US filing. A safety database will also be required in the US, which will include data from G306 and other trials, plus the planned cross-over of G306 placebo patients to treatment with Grass MATA MPL. A final safety database trial will also likely be needed for the US, potentially over the 2024 hay fever season, which is subject to further funding. A one-year paediatric trial will also be required to support the regulatory filing in Germany and could potentially be used to also support a paediatric indication in the US at a later date.
Grass MATA MPL is a key element in Allergy Therapeutics’ medium-term strategy, with a positive G306 outcome helping to secure first FDA approval, allowing entry to the US market potentially from 2026, and also to enable market expansion in Europe. Another key component is VLP Peanut, which could be transformative; first subjects have been screened for imminent dosing in the planned Phase I PROTECT study, with data expected during 2023.

Trinity Delta view: The pivotal G306 Grass MATA MPL Phase III trial is one of two important clinical studies planned, with the other the Phase I PROTECT VLP Peanut trial. Data for both of these key pipeline assets are expected next year, with results from G306 during Q423. The G306 study is fully funded, and should generate reliable and robust results given the size and scope. Management sees $300-400m peak sales for Grass MATA MPL in the US, which could be transformational for Allergy Therapeutics. Our Allergy Therapeutics valuation is £260.8m (38.4p per share) which includes a pipeline valuation of £190.0m (28.0p/share), where we see material upside potential as key programmes, including VLP Peanut and Grass MATA MPL, progress. Following the manufacturing pause, management remains focused on cost control and capital management and is assessing and reviewing all funding options.

Lighthouse

8 December 2022


Price	13.50p
Market Cap	£91.7m
Primary exchange	AIM
Sector	Healthcare
Company Code	AGY

Corporate client	Yes

Company description

Allergy Therapeutics specialises in the diagnosis and treatment of allergy. The existing European business generates c £80m annual sales. Near-term R&D efforts are focused on the Pollinex Quattro platform, whilst in the medium-term the VLP platform is highly promising.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041

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