ASIT biotech has received positive feedback from the FDA on the preparation of the clinical development plan for gp-ASIT+ in the U.S., with only a few comments and the request for some clarification on the Master File.
BRUSSELS--(BUSINESS WIRE)--Regulated 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, has made significant progress in the preparation of the clinical development, in the United States, of gp-ASIT+™, its lead drug candidate for the treatment of grass pollen rhinitis.
ASIT biotech has received positive feedback from the US Food and Drug Administration (FDA) on the preparation of the clinical development plan for gp-ASIT+™ in the United States, with only a few comments and the request for some clarification on the Master File. In July 2017, ASIT biotech filed its answers to the initial comments from the FDA, together with an updated Master File including the results of the first Phase III conducted in Europe between 2015 and 2017.
Once ASIT biotech has answered the final questions and updated the Master File, it will request a pre-IND meeting. The main objective of this meeting with the FDA is to receive its validation that the drug development plan and future clinical trials are acceptable to the US Agency.
Thierry Legon, CEO of ASIT biotech, comments: “We are very satisfied with the significant progress that we have made in the preparation of the clinical development plan of gp-ASIT+™ in the US, the biggest market worldwide for our lead product candidate with 3 million patients allergic to grass pollen treated with immunotherapy. As soon as we will have answered the FDA’s last questions, we will request a pre-IND meeting to discuss the design of our first clinical trial in the US.”
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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
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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
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
