The G309 field study involved two dosing courses of six injections over six and 14 weeks and demonstrated a ‘statistically significant’ improvement of 29.1% and 38.1% respectively compared with the placebo indicating a big reduction in daily symptoms.
The year-long trial involved 119 patients across 14 sites in Germany and the US and was a conducted as a double-blind, placebo-controlled randomised study.
This means neither the patients nor those conducting the trial knew who was receiving the active drug and who received the placebo, avoiding any potential bias from the results.
Grass pollen is one of the most common causes of seasonal allergic rhinitis, or inflammation of the inside of the nose, commonly known as hay fever.
Chief executive Manuel Llobet said: ‘Significantly, the results will enable us to optimally design the upcoming pivotal G306 Phase III field trial, maximising the chances of success and supporting our regulatory plans for entry into the US.’ The trial is due to start in the second half of 2022.
Pharmaceutical analyst Paul Cuddon at Numis noted the new dosing regime required six doses compared with four for the company’s lead product Pollinex Quatto, which raised key questions over its market acceptance.
Cuddon said, ‘The competitiveness of six doses is in our view less certain and may depend on whether the clinical benefit extends over seasons.’
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