- ASIT biotech has obtained positive clinical Phase III data with its gp-ASIT+™ product candidate for grass pollen induced allergic rhinitis demonstrating for the first time ever the 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 only slightly below the originally defined 20% threshold. As most important next step ASIT biotech will work with German regulatory agency to define a pathway to licensure. In this context the complementary analysis of the immunological readouts of the Phase III trial, which elucidate a clear and consistent mechanism of action of gp-ASIT+TM even in an atypical 2017 pollen season, are expected to play an important role.
- Furthermore the understanding of the mechanism of action of gp-ASIT+TM constitutes an outstanding strategic asset of the ASIT+TM technology allowing now a rational design of other pipeline product candidates targeting important allergies.
- The safety and tolerability profile for hdm-ASIT+™, the company second most advanced product candidate in house dust mite rhinitis, has been confirmed in a recent Phase I/IIa trial. A slight positive immunological and clinical impact could be observed in a limited number of treated patients, although the study was not powered to show statistically significant results.
- ASIT biotech has received a €6 million grant from the Walloon government to support an ambitious development program to design, develop and clinically test new product candidates targeting various food allergies induced by peanut, egg white and cow’s milk. This program is performed in collaboration with
Imperial College of London(Prof. Mohamed Shamji) and Guy King’s College Hospital( Dr. StephenTill).
- ASIT biotech’s cash position at year end 2016 was €13.4 million.
Financial results at
|In thousands of euros – IFRS||
|Other operating income||1,667||-3|
|Research & Development expenses||-12,123||-6,691|
|General & Administrative expenses||-1,822||-947|
|Operating profit / loss||-12,278||-7,640|
|Financial income / expense||-60||-75|
|Net profit / loss||-12,339||-7,715|
Operating income, which totaled €1.7 million, consisted of a recoverable advance of €663 thousand from the Walloon government for the hdm-ASIT+™ program and research tax credit of €1,061 thousand. ASIT biotech recorded no revenue in 2016, as the Company is still in its clinical development phase.
Research & Development spending and General & Administrative expenses totaled €13.9 million over the year 2016 (versus €7.6 million at 31
- 80% for the most advanced drug candidate, gp-ASIT+™, to treat grass pollen rhinitis;
- 15% for the second drug candidate, hdm-ASIT+™, to treat house dust mite rhinitis;
- 5% for preclinical activities and the discovery of product candidates for other types of allergies.
The operating loss over the year ending
ASIT biotech had a net cash position of €13.4 million at
- the €23.5 million raised by the Company’s IPO on the
Euronext Brusselsand Euronext Parisregulated markets in May 2016;
- the conversion of €4.1 million of convertible bonds on
12 May 2016.
The Company also benefited from repayable advances from the Walloon government:
- €1.3 million granted in
December 2015for the development of the hdm-ASIT+™ drug candidate, of which €125 thousand is still to be gradually received as this program progresses;
- approximately €6.0 million granted in
January 2017to co-finance the research and development of product candidates to treat food allergies.
Cash burn from operating and investment activities totaled €14.1 million, a level consistent with the Company’s development budget over the last 12 months.
The statutory auditors are currently still auditing the Company’s consolidated financial statements to
Recent clinical and preclinical developments
- gp-ASIT+™ (grass pollen induced allergic rhinitis): at the end of
February 2017, the Company presented the results of the Phase III international clinical trial involving 516 patients suffering from grass pollen induced allergic rhinitis. gp-ASIT+™ induced a 15% to 21% reduction in the combined clinical symptom and medication score (CSMS), which is only slightly below a originally defined 20% threshold. The complementary analysis of the immunological readouts of the Phase III trial elucidates a clear and consistent mechanism of action of gp-ASIT+TM even in an atypical 2017 pollen season. This and the very good consistency of the overall results of the Company’s lead product will allow further discussions with German authorities towards regulatory approval and with US authorities regarding the clinical development strategy for this important market.
- hdm-ASIT+™ (allergic rhinitis to house dust mites): at the end of
November 2016, the Company completed the enrollment of patients for its Phase I/IIa trial in allergic rhinitis to house dust mites undertaken in Germany. A total of 40 patients were successfully selected, of whom 36 were eligible and began the treatment with hdm-ASIT+™. The results, published on 4 April, confirmed a good safety and tolerance profile. The trial showed a somewhat higher numerical reduction in the Conjungtivitis Provocation Test (CPT) reactivity in the treated group compared to the placebo group, although the study was not powered to demonstrate statistical significance. The absence of a larger reduction can be explained, at least in part, by a substantial response to placebo (55%), the limited number of patients and the short observation period in this perennial disease. An optimization of the product candidate will now be performed based on the mechanism of action obtained from the gp-ASIT+TM Phase III results.
Organization and governance
In 2016, the Company strengthened its governance and continued to put together its teams with a view to the ramping up of its R&D programs with the appointment of two world-renowned experts:
Vincent Billeas Vice President of Manufacturing & Controls;
Mohamed Shamjiof Imperial College of Londonas Scientific Advisor for the discovery of new drug candidates and for preclinical activities.
With the positive results of the Phase III with gp-ASIT+TM in grass pollen rhinitis, ASIT biotech has reached a very important clinical development milestones under the presidency of
To secure its development in
Linda Cox, former President of the American Academy of Allergy, Asthma & Immunology (AAAAI) and of the immunotherapy and allergy diagnostics committees of both the AAAAI and the ACAAI ( American College of Allergy, Asthma & Immunology);
Peter Creticos, former Director of the Division of Allergy and Clinical Immunologyof the Johns Hopkins University School of Medicine.
Outlook and upcoming milestones
In 2017, ASIT biotech intends to continue the preclinical and clinical development of its drug candidates in accordance with the planned timeline:
gp-ASIT+TM in grass pollen rhinitis
- Scientific Advise Meeting with
Paul Ehrlich Institute(Q2/Q3) to discuss Phase III data and to define route to German licensure;
- Preparation of a 2nd Phase III in
Europein adults or in children depending on Paul Ehrlich Instituteoutcome (potential study start Q1-2018);
- Scientific Advise Meeting with
FDA(Q3/Q4) to define the clinical development strategy towards licensure in the US.
hdm-ASIT+TM in house dust mite allergy
- Compare immunogenicity profile of hdm-ASIT+TM to gp-ASIT+TM by ex vivo test on house dust mite allergic patients by Q3 to further confirm the product design and to define further clinical development program.
food-ASIT in food allergy
Assess immunogenicity profile of ASIT+TM by ex vivo test on:
- peanut allergic patients by Q3;
- cow’s milk allergic patients by Q4;
- egg white allergic patients by Q4.
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+TM 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+TM and house dust mite: hdm-ASIT+TM), 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
Further information can be found at www.asitbiotech.com.
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.
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Source: ASIT biotech