- 89% of patients who began the treatment
attended the study’s last visit
- No major adverse event has been
observed
- The clinical data is currently being
verified
- Results should be published before the
end of the first quarter of 2017
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, announces that its Phase IIa double-blind
placebo-controlled clinical study in house dust mite-induced
rhinoconjunctivitis1 has completed its clinical phase.
This first clinical trial in house dust mite rhinitis was
undertaken by the team led by Professor Bettina Hauswald, principal
investigator, at the Carl Gustav Carus University Hospital in
Dresden, Germany. Of the 37 patients who began the treatment with
hdm-ASIT+™, 33 attended the last visit to the allergist, giving a
retention rate of 89%.
The main objectives of this study are to evaluate the drug
candidate’s safety and tolerability profile and to determine the
maximum cumulative dose tolerated by house dust mite allergic
patients. The secondary objectives of this study are the assessment
of the impact of hdm-ASIT+™ on the immune system and on the
reduction of the reactivity to a conjunctival provocation
test2.
During the trial, no major treatment-related adverse event was
observed, even at the highest allergen dose, which is 200 times
greater than the first dose administered.
ASIT biotech is currently cleaning the clinical database. This
first step will be followed by the statistical analysis of the data
and the publication of the clinical results by the end of the first
quarter of 2017.
Thierry Legon, CEO of ASIT biotech, comments: “We are
happy because the retention rate of 89% constitutes the first
evidence that our second product candidate, hdm-ASIT+™, is safe and
well tolerated, even at high allergen doses. We are eager to get
the results related to the immunogenicity and the potential
clinical effect of this product candidate targeting the
worldwide-spread house dust mite allergy.”
***
1 This research program is partly funded by the Walloon region
in the form of recoverable advances, in accordance with the
agreement signed at the beginning of 2016.2 A test enabling both
the diagnosis of a patient’s allergy and the determination of their
level of hypersensitivity at various times during the
desensitization process.
About hdm-ASIT+TM
hdm-ASIT+TM product candidate for the treatment of house dust
mite allergy consists of a mixture of natural allergen fragments
obtained from a purified specific proteinic extract from house dust
mite (dermatophagoides pteronyssinus). 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 should be of short
duration compared with currently commercialised treatments. This
should constitute 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).
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170123005934/en/
CompanyASIT biotechThierry Legon, CEO, +32 2 264 03
90investors@asitbiotech.comorMedia and Investor Relations -
FranceNewCapDusan Oresansky / Pierre Laurent, +33 1 44 71 94
92asitbiotech@newcap.euorMedia Relations - BelgiumLaure-Eve
Monfort, +32 2 290 90 93monfort@comfi.be