ASIT biotech

The Quality of the Results Obtained in the Phase III Clinical Study with gp-ASIT+™ Confirmed by the Publication in the Prestigious Scientific Journal ALLERGY

Regulatory News:

ASIT biotech (Paris:ASIT) (BSE:ASIT) (ASIT - BE0974289218), a Belgian clinical-stage biopharmaceutical company specialized in immunotherapy products for the treatment of allergies, publishes a new article in the prestigious scientific journal ALLERGY.

ALLERGY is the official journal of the European Academy of Allergy and Clinical Immunology (EAACI). Its task is to promote links between fundamental and clinical research in the fields of allergies and immunology. It only publishes articles approved by a committee of renowned and independent scientific experts. The selection criteria are the quality and originality of the scientific results presented.

This new article presents the results of the Phase III clinical trial to assess the clinical efficacy of the product candidate gp-ASIT+™ for the immunotherapy treatment of grass pollen-induced rhinitis in real life. These results showed that a short treatment with gp-ASIT+™ (4 medical visits over 3 weeks) induced a convincing and statistically significant reduction in the combined score of symptoms and medication intake during natural exposure to grass pollens.

ASIT biotech has already published the results of the clinical trials with gp-ASIT+™:

• phase I/II (http://www.jacionline.org/article/S0091-6749(17)31572-5/pdf) in the Journal of Allergy and Clinical Immunology (JACI);
• phase IIa (http://onlinelibrary.wiley.com/doi/10.1111/all.13392/full) in the journal ALLERGY;
• the phase IIb (http://onlinelibrary.wiley.com/doi/10.1111/all.13358/full) in the journal ALLERGY.

This fourth publication in a prestigious scientific journal specialized in allergies confirms the quality and robustness of the clinical results obtained by ASIT biotech with its lead product candidate.

Thierry Legon, CEO of ASIT biotech, commented: “This new article in ALLERGY follows the publications of the full clinical development (Phase I to Phase III) of our flagship product candidate, gp-ASIT+™. It will once again draw the attention of the global community of allergists onto the remarkable properties of gp-ASIT+™. The phase III results have demonstrated for the first time ever that allergen peptides are able to reduce, in real life, allergic patients’ symptoms and drug intake after only 3 weeks of treatment with gp-ASIT+™ while other products require several months or even years to reach the same effect.”

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References:
Article in ALLERGY: http://onlinelibrary.wiley.com/doi/10.1111/all.13433/full

About gp-ASIT+™
gp-ASIT+™ product candidate for the treatment of grass pollen rhinitis consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from Lolium perenne pollen. In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000

The administration schedule of the treatment is of short duration compared with currently commercialized treatments. This constitutes 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 commercialization 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.

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.

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