- The clinical efficacy of gp-ASIT+™ has been demonstrated in the BTT-009 Phase III study.
- The first Phase III clinical efficacy data validates the relevance of the ASIT+™ technology platform.
- The German Regulatory Authorities has requested a second Phase III before considering a Marketing Authorization Application submission in Germany, and a future expansion to other European countries.
- To reduce the operational risks and maximize the chances of success of the next Phase III clinical trial with gp-ASIT+™, the patients screening would start by Q4 2018 in order to treat them prior to the 2019 grass pollen season.
- The identification of the mechanism of action of gp-ASIT+™ paves the way for future developments of other ASIT+™ therapeutic product candidates for house dust mite and food allergies, indications with high unmet medical need.
- This understanding has already resulted into an international collaboration with Imperial College London and King’s College Hospital in a rational drug design program for the screening of other ASIT+™ products. This program will reduce the risks and increase the speed of further developments of all ASIT+™ products.
- The first peanut prototype products are currently being tested on blood cells from allergic patients.
- Cash position of €8.2 million at end-June 2017.
BRUSSELS--(BUSINESS WIRE)--Regulatory News:
ASIT biotech (Paris:ASIT) (BSE:ASIT) (ASIT - BE0974289218), a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, announces today its 2017 half-year results, prepared in accordance with the IFRS standards adopted by the European Union, and also provides an update on its R&D programs.
Thierry Legon, CEO of ASIT biotech, says: “The first half of 2017 has been very fruitful and productive regarding the corporate and R&D developments at ASIT biotech.
The key milestone of this period was the disclosure of the first Phase III study results with gp-ASIT+™, our lead product candidate in grass pollen rhinitis. The 15.5% reduction of the CSMS between placebo and treated group during the pollen peak reached statistical significance (p<0.05). However, these results did not reach the predefined 20% difference necessary to the registration of gp-ASIT+™ based on one sole compelling clinical study. All clinical results related to the primary and secondary endpoints as well as post-hoc analyses, have highlighted symptom improvement in patients after only 3 weeks of treatment with gp-ASIT+™. Furthermore, the immunologic study results showed for the first time ever a unique mechanism of action supporting the gp-ASIT+™ clinical efficacy. The understanding of the mechanism of action of ASIT+™ product is a key asset for the Company. It confirms and validates the clinical relevance of our technology platform and constitutes the basis of our rational drug design program for the development of new ASIT+™ products targeting other allergy indications.
As requested by the German Regulatory Authorities (Paul Ehrlich Institute - PEI), these results need to be confirmed in a second Phase III study before considering a Marketing Authorization Application (MAA) submission in Germany, and for a future expansion of this MAA to other European countries. To reduce the operational risk and maximize the chances of success, patient recruitment and screening for the next Phase III study is planned to start end of 2018 before the 2019 pollen season.
In parallel to the preparation of the next Phase III with gp-ASIT+™, the Company will focus on the development of its product portfolio in food and house dust mite allergies, very attractive indications with a high unmet medical need in Europe and worldwide. This development remains in the framework of our rational drug design program in collaboration with Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London. The know-how harvested throughout the gp-ASIT+™ preclinical and clinical developments, the understanding of the ASIT+™ mechanism of action and the fruitful collaboration with Dr. Mohamed Shamji significantly reduce the risk of these new developments. The first peanut prototype products have been transferred to Dr. Mohamed Shamji’s team and are currently being tested on blood cells from allergic patients. This is the first milestone of the ASIT+™ food allergy product development supported by the €6m non-dilutive funding received from the Walloon government.”
