ASIT biotech Publishes the Results of The hdm-ASIT+™ Phase I/II Follow-up Study in House Dust Mite Rhinitis

  • No long-term improvement shown in a follow-up study of the initial Phase I/II with hdm-ASIT+™ performed on a subset of 19 patients (placebo = 5, treated = 14) out of the 36 initially randomized
  • 3 new hdm-ASIT+™ prototype products ready to be sent this week to Imperial College London to select a new drug candidate with an immunogenicity profile equivalent to gp-ASIT+™, ASIT biotech’s lead product candidate for grass pollen rhinitis

BRUSSELS--()--Regulatory News:

ASIT biotech (Paris:ASIT) (BSE:ASIT) (Euronext: ASIT - BE0974289218), a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, published the results of a follow-up study with hdm-ASIT+™ for house dust mite rhinitis.

A follow-up study of the Phase I/II trial with hdm-ASIT+™ was performed at the Carl Gustav Carus University Hospital in Dresden, Germany. Out of the 36 initially randomized patients (9 placebo and 27 treated), 5 placebo and 14 treated patients underwent one complementary medical visit 8 months after the end of the treatment. The objective was to assess a potential long-term improvement on the reactivity to a conjunctival provocation test and the blood levels of house dust mite allergen specific antibodies (IgG, IgG4, IgE and blocking antibodies). This follow-up study did not demonstrate a long-term improvement of these parameters.

3 new prototype products for house dust mite rhinitis have already been designed on the basis of the ASIT+™ technology platform. These will be sent to Imperial College London this week to be tested ex vivo on the blood cells from allergic patients in the framework of a rational drug design program operated in close collaboration with Dr. M. Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London. The objective of this testing is to select a new product candidate with an immunogenicity profile equivalent to the one of gp-ASIT+™, ASIT biotech’s lead product candidate for grass pollen rhinitis.

The next clinical trial with hdm-ASIT+™ is postponed until an hdm-ASIT+™ product candidate is available. Such a product is expected to be selected from the outcome of the ex vivo tests by H1 2018 and the upcoming clinical study with hdm-ASIT+™ is expected to start in 2019.

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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<MW<10,000) include a wide range of epitopes that stimulate the immune system with optimal complexity.
The administration schedule of the treatment should be of short duration compared with currently commercialised treatments. This should constitute a major competitive advantage to improve the acceptance and the compliance of the patients. In addition, the administration schedule includes successive injections with half of the visit dose in both arms, an innovative solution that enables the delivery of the total dose necessary for the therapeutic effect in a faster and safer way. Finally, the product candidate is formulated without adjuvant, which increases the long-term safety of the product by decreasing the local and general reactogenicity as well as the frequency of the adverse events, which represents a further advantage in markets less permissive to adjuvanted formulations (e.g. US).

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.

Forward Looking Statements

All statements in this announcement that do not relate to historical facts and events are “forward-looking statements”. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” “plans,” “continue,” “ongoing,” “potential,” “predict,” “project,” “target,” “seek” or “should” or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company’s intentions, beliefs or current expectations. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance. Given these risks and uncertainties, you should not rely on forward-looking statements as a prediction of actual results. Any forward-looking statements are made only as of the date of this announcement and, without prejudice to the Company’s obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update the forward-looking statements set forth in this announcement.

Important Legal Notice

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.

This announcement is not for distribution, directly or indirectly, in or into the United States or to any U.S. person within the meaning of the U.S. Securities Act of 1933, as amended (the “Securities Act”). The Shares have not been and will not be registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. The Company has not registered, and does not intend to register, any portion of the intended offering of Shares in the United States, and does not intend to conduct a public offering of Shares in the United States.

This announcement and the information contained herein are not for publication, distribution or release in or into the United States, Australia, Canada, Japan or any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction.

The Company is responsible for the information contained in this press release.

Contacts

ASIT biotech
Thierry Legon, CEO
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

Contacts

ASIT biotech
Thierry Legon, CEO
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