ASIT biotech has reduced the size of its organization and re-focus on developing treatments for food allergies, following the results of the Phase III trial of its gp- ASIT+ treatment in grass pollen allergy.
Real-life exposure trials required for respiratory programs such as gp-ASIT+ represent inherent challenges that are difficult to overcome even for big pharma. In the recent Phase III trial (ABT-gpASIT011), gp-ASIT+ showed a 0.15 (p=0.05) absolute reduction in the Combined Symptom and Medication Score (CSMS) during the peak of the grass pollen (GP) season, and a 0.18 (p=0.005) absolute reduction in the CSMS during the entire GP season, versus the primary endpoint of 0.30. Both groups took an extensive amount of other medication against allergic symptoms during the study period, which potentially masked the efficacy of gp-ASIT+, and despite this the data show a statistically significant treatment effect over placebo, consistent with the previous Phase III trial (BTT009). Moreover, blood analysis of immunological parameters has confirmed an immune response in gp-ASIT+ patients, in line with the mechanistic study published in the Journal of Allergy and Clinical Immunology earlier this year, but the persistence of the effect was not long enough, potentially questioning gp-ASIT+ dosing.
Based on the extensive pre-clinical and clinical data sets across all of its programs, ASIT biotech firmly believes its technological platform can be adapted to any protein- based allergen, and that there is extensive value in further developing a pipeline against food allergens where the unmet need is the highest.
The Board of Directors has mandated the management of ASIT biotech to explore strategic options during H1 2020 to retain maximum shareholder value, supported by current cash position of 3.7 M. ASIT biotech's assets are its innovative technological platform and pipeline, protected by strong intellectual property (IP); offices, laboratories and a good manufacturing practice (GMP) certified manufacturing site in Belgium; as well as a dual listing on EURONEXT in Brussels and Paris. ASIT biotech believes there could be additional value for ASIT shareholders if a partner can be identified to fund further...