The double-blind, placebo-controlled G301 study has examined the safety and efficacy of Pollinex Quattro in the treatment of seasonal allergic rhino-conjunctivitis (SAR) caused by grass pollen. The study compares the symptom or medication score of patients given four injections of Pollinex Quattro to those patients receiving placebo. Before entry into the study, patients had suffered from SAR for an average of over 20 years and reported having moderate to severe symptoms.
Patients were randomly and equally allocated to receive Pollinex Quattro or placebo. In the intent to treat population (all patients in the study) there was a 13.3% improvement with Pollinex Quattro over placebo (p = 0.0038), as measured by a reduction of the combined symptom/medication score (the primary efficacy endpoint). In the prospectively defined patient population who fully recorded key outcomes, Pollinex Quattro showed a dramatic improvement of 26.9% over placebo (p = 0.0031) in the same efficacy endpoint.
The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has statistically significant clinical benefits over placebo. The company intends to use the results to support a marketing approval application in the EU with a submission planned for the first quarter of 2009.