- This new product candidate has been selected to induce the same mechanism of action as gp-ASIT+ which has demonstrated its fast onset of action and its efficacy in an initial phase III trial for grass pollen allergy
- The selection of this new product confirms the versatility of the ASIT+ technology platform, which promote the development and the selection of new allergy immunotherapy active ingredients on strong scientific basis
- ASIT biotech now has three product candidates selected on the ASIT+ platform for allergies with the highest prevalences: allergic rhinitis caused by grass pollen, peanut allergy and house dust mite allergy
Regulatory News:
ASIT biotech (Paris:ASIT) (BSE:ASIT) (Euronext: ASIT BE0974289218), a Belgian biopharmaceutical company specialising in allergy immunotherapy, is today announcing that it has identified, as part of a collaborative programme with Imperial College London, a new product candidate hdm-ASIT+ for the treatment of house dust mite allergy.
The new product candidate was selected among four prototypes designed from the ASIT+ platform, on the basis of the results of the ex vivo tests carried out by the team of Prof. Mohamed Shamji (Imperial College London) on the blood cells of allergic patients. This selection was initiated in October 2017 following the phase I/II follow-up study carried out with the first product candidate.
Like the pnt-ASIT+ product candidate, recently selected for the development of a peanut allergy treatment, the new product candidate hdm-ASIT+ is a mixture of natural peptides with an immunological signature comparable to that of the gp-ASIT+ product candidate (allergy to grass pollens), which has demonstrated, in a first phase III clinical trial, its ability to rapidly trigger the natural regulatory mechanisms for the allergic reaction.
Prof. Mohamed Shamji, Senior Lecturer at Imperial College London, said: "This new product candidate hdm-ASIT+, for the treatment of allergy caused by house dust mites, was selected with the new ex vivo screening method on blood cells from allergic patients that we have developed in collaboration with ASIT biotech. Based on the results obtained at this stage, I believe that this new product has the adequate immunological properties to stimulate the natural regulatory mechanisms for the allergic reaction induced by house dust mites."
Thierry Legon, CEO of ASIT biotech, concluded: "We are delighted that our collaboration with Imperial College London has enabled us to identify, within a few months, two new clinical candidates: pnt-ASIT+ for peanut allergy and hdm-ASIT+ for house dust mite allergy. These studies also allowed us to understand why our first product candidate had a suboptimal immunological profile. All these results further prove the versatility of our technology platform and its ability to generate, on a strong scientific basis, product candidates for the immunotherapy of allergies with high unmet medical need. Eventually, this new product candidate could provide an effective, well tolerated treatment solution for millions of patients suffering from house dust mite allergy."
About house dust mite allergy
Dust mites are microscopic organisms that feed on house dust and moisture in the air. They are among the most common indoor allergens, and symptoms can arise all year round. As well as allergic rhinitis, dust mite allergy can also trigger asthma and eczema flare-ups. In addition, the incidence and prevalence of respiratory allergies is increasing every year, all around the world. In Europe, 23% of people suffer from allergic rhinitis and 52.5% of those people suffer from dust mite allergy, i.e. 12% of the European Union population1
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+ and house dust mite: hdm-ASIT+), and food allergies (peanut allergy: pnt-ASIT+). These products 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 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.
The Company is responsible for the information contained in this press release.
1 Sources :
https://acaai.org/allergies/types/dust-allergy
Bauchau V Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J. 2004 Nov 24 (5):758-64:
View source version on businesswire.com: https://www.businesswire.com/news/home/20180624005057/en/
Contacts:
Company
ASIT biotech
Thierry Legon, +32 2 264 03 90
CEO
investors@asitbiotech.com
or
Media and Investor Relations France
NewCap
Dusan Oresansky Pierre Laurent, +33 1 44 71 94 92
asitbiotech@newcap.eu
or
Media Relations Belgium
Laure-Eve Monfort, +32 2 290 90 93
monfort@comfi.be