The ASIT+TM products are based the ASIT biotech proprietary technology platform. The lead product gp-ASIT+TM for grass pollen rhinitis is currently in phase III. The second product candidate hdm-ASIT+TM targets house dust mite rhinitis, its preclinical development is completed. Two other ASIT+TM product candidates are currently in discovery phase.
ASIT biotech’ ASIT+TM products are innovative, designed to avoid the limitations of existing immunotherapy products and to satisfy expectations of patients and health care providers in terms of efficacy, safety and easiness of use.
The preclinical, clinical and production process of gp-ASIT+TM for the treatment of allergic rhinitis is aplicable to the development of allergen fragments from other allergens such as house dust mite, ragweed and food allergens like peanut and egg white. The flexibility of the platform allows adapting the process to the particular characteristics of a specific allergen.
gp-ASIT+TM for the treatment of grass pollen rhinitis
ASIT biotechs’ strategy is to develop products to satisfy unmet medical needs, so the target population of gp-ASIT+TM are those suffering from moderate-to-severe allergic rhinitis. The fact that one third of the patients suffering from moderate-severe allergic rhinitis also have asthma will improve the medico-economic impact of gp-ASIT+TM.
The target product profile of gp-ASIT+TM product candidate consists among others of:
- a ready to use natural allergen-fragment based product;
- an adjuvant free product; a safety profile in line with best-in-class products;
- a relatively short treatment schedule with a maximum of 4 treatment visits over 3 weeks, prior to allergen exposure;
- a rapid onset of action, both on symptomatic and immunological parameters; and a superior clinical efficacy during natural grass pollen exposure.
The safety, the immunogenicity and the potential clinical efficacy of gp-ASIT+TM using subcutaneous delivery have been confirmed in phase I, phase IIa and phase IIb clinical trials in patients with grass pollen rhinitis.
hdm-ASIT+TM for the treatment of house dust mite asthma
hdm-ASIT+TM has the potential to revolutionize the treatment of underlying allergen sensitization in asthmatic patients through a convenient, safe, short-course treatment which would decrease asthma exacerbations, reduce usage of rescue medication (short-acting β2-agonists and inhaled corticosteroids), reduce hospitalizations and emergency room visits, and strongly reduce absenteeism and improve productivity. This is predicated on hdm-ASIT+TM significantly reducing asthma exacerbations due to allergen exposure, and decreasing the economic consequences of these attacks (emergency department visits or hospitalizations, use of rescue medications, physician visits, etc.).
The product candidate consists of a mixture of natural peptides (ranging from 1,000 to 10,000 kDa) obtained from the purified specific allergen extracted from Dermatophagoïdes pteronyssinus bodies.
The product is supplied as ready to use, sterile and stable solution, which contains no adjuvants or preservatives. As for gp-ASIT+TM product, the different doses to be administered are obtained by increasing the volume of the injected solution.
The Company expects to pursue its investment in its two product candidates until commercialisation and start research and development on new product candidates (allergies to peanut, egg white, cow milk, etc.) to build its pipeline of products.