ASIT biotech Announces the Publication of Its First Clinical Data with gp-ASIT+™ in the Journal of Allergy and Clinical Immunology (JACI)

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 the publication of the first clinical trial data with gp-ASIT+™, its lead product candidate for grass pollen rhinitis, in the Journal of Allergy and Clinical Immunology (JACI), the official scientific journal of the American Academy of Allergy, Asthma and Immunology (AAAAI). Respected worldwide, JACI is a prestigious peer reviewed journal with an impact factor as high as 13.081. With 46,218 citations in 2016, it is the most cited in the field of allergy and clinical immunology.

The results are established on a state of the art double-blind, placebo-controlled, study design and demonstrated that:

• 5 consecutive injections of gp-ASIT+™ in patients with grass pollen rhinitis, are safe and well tolerated,
• the treatment was associated with the induction of grass pollen specific antibodies capable of blocking the allergic reactions responsible for grass pollen rhinitis in human.

The authors conclude that gp-ASIT+™ is a potential candidate for Allergen Immunotherapy (AIT) and is to be further validated in AIT trials. All the clinical studies conducted with gp-ASIT+^TM since then and up to Phase III have confirmed and validated the results of this first clinical study.

Thierry Legon, CEO of ASIT Biotech, commented: "The publication of our data in a renowned peer-reviewed journal such as JACI confirms the quality of our work. For the first time, we have shown in collaboration with Dr. Mohamed Shamji, Associate Professor at Imperial College London, that gp-ASIT+™ has a reduced allergenicity while keeping the necessary immunogenicity to treat the allergic patients. These results constituted a reliable basis for the further clinical developments of our lead product candidate up to the end of the first Phase III.”

Dr. Mohamed Shamji added: "I am delighted that our first clinical study has been accepted by the allergy scientific community and that the data characterizing gp-ASIT+™ has been accepted for publication in JACI. This publication emphasizes the validity of the short-course injections formulation of gp-ASIT+™ as a promising treatment for seasonal allergic rhinitis.”

References:
Article in JACI (click here)
News on the Imperial College London website (click here)

***

About the Journal of Allergy and Clinical Immunology (JACI)

JACI is the official scientific journal of the American Academy of Allergy, Asthma and Immunology (AAAAI). Respected worldwide with 46,218 citations in 2016, it is the most cited journal in the field of allergy and clinical immunology. Each monthly issue features the very latest and best research in the allergy / immunology specialty, with a special interest in clinical medicine and basic science as it translates into optimal patient care. JACI is one of the most prestigious journals in the field of allergy and immunology (ranked 6 out of 150), with an impact factor of 13.081 (the impact factor is a measure of scientific prestige and influence based on the frequency with which that journal is cited by other publications).

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<MW<10,000) include a wide range of epitopes that stimulate the immune system with optimal complexity.

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).

Except for the clinical efficacy during natural grass pollen exposure that was investigated in the first phase III clinical study with gp-ASIT+™, all the above-mentioned characteristics have been demonstrated in the already conducted clinical studies.

The phase III clinical study of gp-ASIT+™ was conducted in 67 clinical centers in Belgium, the Czech Republic, France, Germany, Italy and Spain, and involved 554 randomized patients suffering from grass pollen rhinoconjunctivitis.

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171012005923/en/