ASIT biotech reports positive results in its Phase III clinical trial with gp-ASIT+™ for grass pollen induced allergic rhinitis

  • First ever clinical study to demonstrate the clinical efficacy of allergen peptides in a real-life setting
  • gp-ASIT+™ induced a 15% to 21% reduction in the combined clinical symptom and medication score (CSMS) which is considered as satisfactory despite an atypical pollen season
  • Identification of a novel mechanism of action for gp-ASIT+TM allows further development and optimization of the ASIT+™ portfolio of product candidates
  • Results allow further discussions with regulatory agencies in Germany and the US regarding gp-ASIT+™ clinical development

BRUSSELS--()--Regulatory 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, reports positive results for its Phase III clinical trial in grass pollen rhinitis.

The study was conducted in 67 clinical centers in Belgium, the Czech Republic, France, Germany, Italy and Spain, and involved 554 randomized patients.

gp-ASIT+™ consistently improved clinical symptoms and reduced medication use in allergic rhinitis patients by between 15 and 21% compared to placebo, depending on the type of analyses performed (peak vs. entire pollen season, intention-to-treat (ITT) vs. per protocol (PP) population). More specifically, the statistical significance of the primary endpoint, the mean combined clinical symptom and medication (CSMS) score during the peak pollen period, reached p<0.041 using non-parametric testing (Mann-Whitney) and p<0.078 using parametric testing (ANOVA using square root transformation of the scores) on the ITT population. Similar results were obtained when assessing the entire pollen period.

These results confirm:

  • the use of the Conjunctival Provocation Test (CPT) as a surrogate marker of clinical efficacy and the reduction in the reactivity score to this test induced by gp-ASIT+™ (p<0.01);
  • the induction by gp-ASIT+™ of grass pollen allergen-specific IgG4 and blocking antibodies (assessed on a subset of 32 patients);
  • the overall good tolerability of gp-ASIT+™, as demonstrated by the occurrence of mostly mild adverse reactions and the absence of new or unexpected safety findings.

Following additional analyses, full results will be presented at upcoming scientific meetings.

Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, states: “These positive results are consistent with previous studies performed with gp-ASIT+™ in grass pollen rhinitis, and confirm the efficacy and safety of gp-ASIT+™ in this patient population by activating the regulatory mechanisms of the patient’s immune system. I am delighted to have identified for the first time a novel mechanism of action of gp-ASIT+TM. These findings will be reported in a research article which will be published in a high impact factor scientific journal.”

Thierry Legon, ASIT biotech’s CEO says: “We are pleased to report the first ever clinical study to demonstrate the clinical efficacy of allergen peptides in a real-life setting. This study confirms the effectiveness of our gp-ASIT+™ grass pollen product, and we are looking forward to discussing the detailed results with regulatory agencies in Germany and the US to determine a clear pathway to further clinical development and marketing authorization. Furthermore, the finding of the mechanism of action further supports the development of the ASIT+™ product portfolio targeting house dust mite, ragweed and food allergies. As described in the IPO prospectus, we will explore additional financial opportunities to develop new ASIT+™ products.”

Conference call on 1st March, 2017 at 10:30 AM (CET)

ASIT biotech’s senior management, accompanied by Dr. Mohamed Shamji, Scientific Advisor at ASIT Biotech and Associate Professor at Imperial College London, will hold a conference call in English 1st March, 2017 at 10:30 AM (CET) in order to present its results and answer your questions. To access this conference call, please dial the applicable number:

From France: +33 1 70 77 09 44
From Belgium: +32 2 4040629
From UK: +44 2 033679453
From the United States: +1 6467224908

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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 is investigated in the current first phase III clinical study with gp-ASIT+™, all the above-mentioned characteristics have been demonstrated in the already conducted clinical studies.

As a result, the Company believes that gp-ASIT+™ is the only short course treatment AIT product without adjuvant that is currently in phase III clinical studies with positive and statistically significant efficacy and immunogenicity results obtained during the phase IIa and phase IIb clinical studies.

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.

Contacts

Company
ASIT biotech
Thierry Legon, CEO, +32 2 264 03 90
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

Contacts

Company
ASIT biotech
Thierry Legon, CEO, +32 2 264 03 90
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