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+™
Regulatory News:
ASIT biotech (Euronext: ASIT BE0974289218) (Paris:ASIT) (BSE:ASIT), 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 (see press release from 4 April 2017).
The study is carried out at the Carl Gustav Carus University Hospital in Dresden, Germany. The conjunctival provocation test (CPT)1 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.
About hdm-ASIT+™
hdm-ASIT+™ product candidate for the treatment of house dust mite allergy consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from house dust mite (dermatophagoides pteronyssinus). In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000
About ASIT biotech
ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+™ technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech's product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+™ and house dust mite: hdm-ASIT+™), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.
ASIT biotech has a headcount of 22 staff members, at its headquarters in Brussels and a laboratory in Liège, Belgium.
Further information can be found at: www.asitbiotech.com.
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This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of ASIT biotech SA (the "Company" and the "Shares"). Any purchase of, subscription for or application for, Shares to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus and any supplements thereto, as the case may be. This announcement does not constitute a prospectus and the information contained herein is for information purposes only and does not purport to be full or complete. Investors should not subscribe for any Shares except on the basis of the information contained in the prospectus that the Company expects to publish after its approval by the Belgian Financial Services and Markets Authority, and which can then be obtained at the Company's registered office and on www.asitbiotech.com.
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1 A test enabling both the diagnosis of a patient's allergy and the determination of their level of hypersensitivity at various times during the desensitization process.
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Contacts:
Company
Thierry Legon, CEO
ASIT biotech
Tel. +32 2 264 03 90
investors@asitbiotech.com
or
Media and Investor Relations France
NewCap
Dusan Oresansky Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu
or
Media Relations Belgium
Laure-Eve Monfort, Tel.: +32 2 290 90 93
monfort@comfi.be