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ASIT biotech announces follow-up study of Phase I/IIa clinical trial for house dust mite rhinitis
A subset of patients treated during the Phase I/IIa clinical trial with its hdm-ASIT+™ product candidate for house dust mite rhinitis will undergo a complementary medical visit to assess potential long-term effect of hdm-ASIT+™.


ASIT biotech, a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, announces it has received the approval of the regulatory authorities and ethical committee to start a follow-up study with the patients enrolled during the Phase I/IIa clinical trial of its product candidate for house dust mite rhinitis.

The study is carried out at the Carl Gustav Carus University Hospital in Dresden, Germany. The conjunctival provocation test (CPT) showed a slight numerical difference in favor of the treated group compared to the placebo group in the original study. The objective of this follow-up study is to evaluate whether longer natural exposure to house dust mites may have an impact on immunological and reactivity parameters, and assess a potential long-term effect of hdm-ASIT+™.

A subset of the 36 initially randomized patients (27 treated with hdm-ASIT+™ and 9 with placebo) will undergo a complementary medical visit in order to assess their reactivity score to a CPT and their titles of house dust mite allergen specific antibodies (IgG, IgG4, IgE and blocking antibodies).

Thierry Legon, CEO of ASIT biotech, says, “The immunogenicity parameters and CPT score that were tested as a secondary endpoint one week after the end of the treatment with hdm-ASIT+™ were improved between the treated group and the placebo. It is clinically and scientifically sound to test a potential long-term effect of our product against house dust mite-induced rhinoconjunctivitis. An increase of the IgG4 and the blocking antibodies associated to a reduction of the CPT score in treated patients would show that a long term natural challenge is needed to allow the treatment clinical efficacy. In parallel to this follow-up study, we are actively working on the design of an optimized version of hdm-ASIT+™ based on our improved understanding of the mechanism of action of our lead product gp-ASIT+™ following the results of the Phase III study in grass pollen rhinitis.”

Source: ASIT biotech

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APBN Editorial Calendar 2017
January:
Healthcare Focus: LUNGS
February:
War on CANCER
March:
Get to Know TCM
April:
Diabetes: The Big Picture
May:
The Piece of Your Mind - Brain Health/Science
June:
Advocacies in Support of Rare Disease Patients
July:
Food Science & Technology
August:
Eye – the Window to your Soul
September:
Infectious Diseases
October:
No. 1 Killer — Heart Diseases
November:
Diseases threatening our Children
December:
Skin Diseases/Allergic Reactions
Editorial calendar is subjected to changes.
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