ASIT soon to discuss with US and German regulatory on further development and marketing its grass pollen product

ASIT biotech, a Belgian clinical-stage biopharmaceutical company could soon market its gp-ASIT+ grass pollen product, as it showed positive results in Phase III clinical trial in grass pollen rhinitis.

The international study conducted in 67 clinical centers in Belgium, the Czech Republic, France, Germany, Italy and Spain, and involved 554 randomized patients showed that gp-ASIT+ consistently improved clinical symptoms and reduced medication use in allergic rhinitis patients by between 15 and 21% compared to placebo in different types of analyses.

Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, said that the positive results were consistent with previous studies performed with gp-ASIT+ in grass pollen rhinitis, and confirm the efficacy and safety of gp-ASIT+ in this patient population by activating the regulatory mechanisms of the patient’s immune system.

Thierry Legon, ASIT biotech’s CEO is pleased to see the study results that showed the clinical efficacy of allergen peptides in a real-life setting. “This study confirms the effectiveness of our gp-ASIT+ grass pollen product, and we are looking forward to discussing the detailed results with regulatory agencies in Germany and the US to determine a clear pathway to further clinical development and marketing authorization.”

The ASIT’s boss said that further development is planned to target house dust mite, rageweed and food allergies. “We will explore additional financial opportunities to develop new ASIT+ products,” concluded Legon.