Belgian clinical-stage biopharmaceutical firm ASIT Biotech has reported positive results from its Phase III clinical trial of gp-ASIT+ for the treatment of patients with grass pollen-induced allergic rhinitis.
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gp-ASIT+ is a product candidate containing a mixture of natural allergen fragments extracted from a purified specific proteinic extract of Lolium perenne pollen.
The natural peptides are comprised of multiple epitopes that stimulate the immune system with optimal complexity.
The results indicated that the product has improved clinical symptoms and minimised the use of medication in allergic rhinitis patients by 15%-21% when compared to placebo.
The randomised Phase III trial was conducted in 554 patients in 67 clinical centres within Belgium, Czech Republic, France, Germany, Italy and Spain.
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By GlobalDataASIT biotech chief executive officer Thierry Legon said: “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 authorisation.
“Furthermore, the finding of the mechanism of action further supports the development of the ASIT+ product portfolio targeting house dust mite, ragweed and food allergies. As described in the IPO prospectus, we will explore additional financial opportunities to develop new ASIT+ products.”
The primary endpoint measured as the mean combined clinical symptom and medication (CSMS) score during the peak pollen period was found to be consistent with the results obtained during the entire pollen period.
It was also found that gp-ASIT+ triggers grass pollen allergen-specific IgG4 and blocks antibodies, in addition to having good overall tolerability.
Image: Pollen from grass. Photo: courtesy of Unsplash / Wikipedia.
