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ASIT AIW ASIT biotech's Scientific Advisory Boards (SAB) provide positive recommendations on the clinical development of gp-ASIT+?

Transparency directive : regulatory news

29/03/2019 07:00

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The SAB, composed of international experts in the field of allergy immunotherapy, acknowledged the clinical benefits of gp-ASIT+™ and confirmed the interest of a follow-up study to enhance the future market positioning and differentiation of the compound

Regulatory News:

ASIT biotech (BSE:ASIT) (Paris:ASIT) (Euronext: ASIT - BE0974289218), a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced the positive outcomes and recommendations following the meetings of its scientific advisory boards, bringing together 9 of the most recognized international experts in the field of allergy immunotherapy.

Three topics were discussed by the experts:

  • the best positioning of gp-ASIT+™, the lead product candidate of the Company for grass pollen rhinitis currently evaluated in a confirmatory phase III study, within the context of existing therapeutic approaches,
  • a project of a second pollen season follow-up treatment of patients suffering from grass pollen allergy currently included in the gp-ASIT+™ Phase III trial (gpASIT011),
  • the Paediatric Investigational Plan to be proposed in view of the Marketing Authorization Application submission expected next year in Germany.

These very fruitful discussions led to:

  • acknowledging the benefit of gp-ASIT+™ as a fast acting short-course treatment compared to the currently available immunotherapy products,
  • confirming the interest of additional data on sustained or even improved effect of gp-ASIT+™ after an additional cycle of treatment preceding a second pollen season and to defining the optimal design of this follow-up study,
  • clarifying the optimal approach to address the challenges of paediatric development for innovative pre-seasonal short-course subcutaneous compounds.

The advices delivered during these two meetings held in March 2019 will support the ambitious clinical development program of ASIT biotech in grass pollen rhinitis. The results of the gpASIT011 study aiming to confirm the favourable benefit-risk ratio of gp-ASIT+™ are expected by the end of this year and will drive the market access strategy for this lead compound in this highly prevalent allergy.

Michel Baijot, CEO of ASIT biotech, commented: “I am happy that some of the most renowned European key opinion leaders in the field of allergy are supporting gp-ASIT+™ as the new therapeutic alternative with potential long-term benefits to patients with moderate to severe allergic rhinoconjunctivitis.”

***

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 allergy immunotherapy (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 contains three novel ASIT+™ product candidates targeting respiratory allergies with the highest prevalence (i.e. grass pollen: gp-ASIT+™ - in ongoing phase III - and house dust mite: hdm-ASIT+™), and food allergies (peanut allergy: pnt-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 26 staff members, at its headquarters in Brussels and its facilities 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.

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

Company
Michel Baijot, CEO
ASIT biotech
Tel.: +32 2 264 03 90
investors@asitbiotech.com

Media and Investor Relations - France
NewCap
Dusan Oresansky / Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu

Media Relations - Belgium
Laure-Eve Monfort
Tel.: +32 2 290 90 93
monfort@comfi.be