Who we are

ASIT biotech is a clinical stage (Phase 3) biopharmaceutical company publicly listed on EURONEXT (Brussels & Paris).

ASIT biotech’s mission is to lead an evolution in allergy therapeutics by creating a new generation of highly effective and efficient immunotherapy options for respiratory and food allergies. Our goal is to generate breakthrough treatments that deliver rapid, recognizable improvement in the life of allergy patients, within weeks rather than months or years following treatment initiation.

Thanks to our innovative ASIT+™ technology platform, ASIT biotech is currently the only developer of allergy immunotherapy (AIT) product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection, without adjuvant. Resulting in a short treatment period, which is expected to improve patient compliance and ultimately results in an improved treatment.

ASIT biotech’s product pipeline consists of three novel ASIT+™ product candidates targeting respiratory allergies with the highest prevalence (i.e. grass pollen: gp-ASIT+™ - in ongoing phase III, house dust mite: hdm-ASIT+™), and food allergies (peanut allergy: pnt-ASIT+™). Each of these indications constitute substantial commercial opportunities in the immunotherapy market.

The ASIT+™ platform is flexible and is potentially applicable across a range of allergies.


Key milestones

Launch of a second Phase III study for gp-ASIT+ in grass pollen rhinitis in 6 EU countries with 651 patients randomized (results expected in Dec 2019)

Publication of the mechanistic (mode of action) study of gp-ASIT+ in the Journal of Allergy and Clinical Immunology

GMP certification of gp-ASIT+TM production line

Selection of pnt-ASIT+™, product candidates in the domain of food allergies, specifically targeting peanut allergy

Selection of a new hdm-ASIT+, product candidate against house dust mite allergy, with an improved immunological profile

ASIT biotech has installed and qualified a pilot unit to produce clinical batches for Phase I/II studies. The active pharmaceutical ingredients (API) will be produced in a clean room rented from Accessia Pharma, a provider of high-quality pharmaceutical infrastructures in Liège, Belgium

Initiation of first Phase III clinical study with gp-ASIT+ in grass pollen rhinitis

International collaboration with Imperial College London and King’s College Hospital in a rational drug evaluation program for the screening of other ASIT+™ products

ASIT biotech successfully completes its initial public offering on Euronext Brussels and Euronext Paris, raising €23.5M

ASIT biotech raises capital to finance the first Phase III clinical study with gp-ASIT+

BTT-gpASIT009 Phase III study: launch in six European countries

hdm-ASIT+: completion of the regulatory preclinical development

BTT-gpASIT007 Phase IIa study: proof of concept reached by the demonstration of the clinical effect of gp-ASIT+ in an allergen provocation test

BTT-gpASIT008 Phase IIb study: selection of the optimal dose/regimen of gp-ASIT+ to be tested in a Phase III clinical study

hdm-ASIT+TM: initiation of the preclinical development of a first product candidate for the treatment of house dust mite asthma

BTT-gpASIT006 Phase IIa study: demonstration of a one season lasting effect of gp-ASIT+

BTT-gpASIT004 Phase I study: demonstration of safety and immunogenicity of subcutaneous administration of gp-ASIT+TM, a product candidate for the treatment of grass pollen rhinitis