ASIT biotech’s house dust mite rhinitis therapy achieves Phase I/IIa endpoint

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Although ASIT's drug against house dust mite allergy has proven to be safe, little clinical efficacy has been detected.

Allergy specialist ASIT biotech has announced the results of its Phase I/IIa (first-in-human) double-blind placebo-controlled clinical trial in house dust mite rhinitis.

The trial’s primary endpoint was achieved, insofar as hdm-ASIT+™ showed, at this stage, a good safety and tolerability profile for the product candidate. No serious or unexpected adverse treatment-related event was observed during the trial, even at the highest allergen dose of 200 µg, which was 200 times greater than the first dose administered. The two groups were comparable at baseline for all the tested parameters, with the exception of house dust mite allergen-specific IgE antibodies, which were substantially lower in the treated group than the placebo group.

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Assessing hdm-ASIT+™’s impact on the immune system and on the reduction in reactivity to a conjunctival provocation test (CPT) were amongst the secondary objectives. An effect was observed on the immune system in a limited number of patients. However, there was no difference overall between the treated group and the placebo group with regard to immunogenicity parameters. Lastly, the trial showed a somewhat stronger reduction in CPT reactivity in the treated group compared to the placebo group. The study was not powered to show statistical significance. The absence of a larger reduction can be explained by a substantial response to placebo (55%), the limited number of patients, the short observation period in this perennial disease and/or the nature of the product.|

  • Confirmation of hdm-ASIT+™’s safety and tolerability profile

  • The conjunctival provocation test showed a slight numerical difference in favour of the treated group compared to the placebo group (not statistically significant). Immunogenicity parameters remained similar in both groups.

  • Thanks to the understanding of the mechanism of action in the Phase III trial undertaken with gpASIT+™, these results make it possible to continue the optimization of hdm-ASIT+™ which will be tested in a future trial

Thierry Legon, ASIT biotech’s CEO says: “We are pleased to have achieved the primary endpoint of the trial, which at this stage confirms the safety and tolerability profile of hdm-ASIT+™, even at high allergen doses. Regarding the results relative to the secondary objectives, we will carry out an in-depth analysis of this data in order to learn all the lessons we can from it. Thanks to the understanding of the mechanism of action in the Phase III trial recently completed with gpASIT+TM, we are confident that we will be able to rapidly develop an optimized version of hdm-ASIT+™ that will be tested in a future clinical trial.”

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