ASIT Biotech has announced results from its Phase III trial of gp-ASIT in grass pollen allergy, in which the drug failed to meet its primary endpoint of a 20% reduction in the combined symptom and medication score (CSMS) during peak grass pollen (GP) season.
The clinical stage biopharmaceutical company, which focuses on the research and development of breakthrough immunotherapy products for the treatment of allergies, announced that the study missed the target of 0.30 absolute reduction in the Combined Symptom and Medication Score (CSMS) in the treated group compared to placebo during the peak of the GP season.
The treatment managed to hit an 0.15 (p=0.05) absolute reduction in the CSMS during ‘peak season’, and a 0.18 (p=0.005) absolute reduction in the CSMS during the entire season, but both scores only translated to an efficacy of 7.4% and 9.8% respectively, falling short of the expected 20%.
Michel Baijot, chief executive officer of the company stated: “Although the execution of the
study was flawless and despite a good safety profile in line with previous results, these efficacy results are disappointing. As of 24th November 2019, the company had a cash position of £3.8 million Euro. We will analyse the data further and assess best options for the company on which we will communicate by year end.”
ASIT Biotech’s product pipeline currently contains three novel ASIT+ product candidates, targeting respiratory allergies with the highest prevalence as well as food allergies.