- The treatment phase of the confirmatory
phase III clinical study with gp-ASIT+™ in grass pollen rhinitis is
now completed for all patients, in time before the grass pollen
season, with no major safety concerns. DSMB recommends continuing
the study without modification.
- The Company appointed an experienced
Chief Financial Officer, Frank Hazevoets, to support its further
development.
Regulatory News:
ASIT biotech (BSE:ASIT) (Paris:ASIT) (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, today announced the achievement of new
clinical and corporate development milestones.
The confirmatory phase III clinical study with gp-ASIT+™ is
on track with the last treatment visit of the last patient reached
before the start of the pollen season
A total of 651 patients with moderate to severe allergic
rhinitis have been treated, above the initial target of 624
patients. This high number of patients has been reached earlier
than planned, that reflects the strong interest for the
short-course immunotherapy developed by ASIT biotech and provides a
solid sample for statistical analysis.
Safety data were followed up by an independent Data Safety
Monitoring Board (DSMB) on a weekly basis during this treatment
period. The DSMB always recommended to continue the study without
modification.
Patients monitoring and data collection in 70 participating
European centers is ensured using performant electronic diaries.
The whole process during the entire pollen season will be under the
tight control of the ASIT biotech clinical team and the dedicated
CRO, ICON Plc., with the aim of obtaining primary efficacy results
by end-2019 as expected.
Frank Hazevoets appointed as Chief Financial Officer
Previously CFO at Promethera Biosciences, a private
biopharmaceutical company targeting liver diseases, Frank Hazevoets
has over 25 years’ experience in defining and executing financial
strategies for both listed and private companies, raising capital
and creating value for shareholders. He held leading financial
positions in Investment Banking (Director of Investment Banking at
BBL/ING from 1999 to 2001), and the consumer-goods sector (Director
Strategy and External Growth at AB InBev from 2001 to 2006). He
then entered the life sciences industry as CFO and Company
secretary at TiGenix (2006-2012), a Belgian biopharmaceutical
company recently acquired by Takeda, where he actively participated
in the IPO, supported its funding and growth strategy as well as
contributed to the first European marketing authorization obtained
for its cell-based drug candidate in cartilage repair.
Frank Hazevoets holds a Master degree in Business Economics and
a Master degree in Engineering in Artificial Intelligence &
Cognitive Science from the Katholieke Universiteit Leuven (K.U.
Leuven).
“I am delighted to join ASIT biotech at a time when the company
is executing its confirmatory Phase III study of its lead compound,
gp-ASIT+TM. I look forward to working closely with the team in
order to continue the excellent work accomplished so far in such a
short timeframe on both the financing and scientific fronts. We
will capitalize on this sound base and implement a detailed
financial roadmap to support the growth of the Company. With the
strong involvement of Yves Désiront, we also expect to successfully
complete, by the end of the second quarter of 2019, the private
placement of convertible notes announced previously,” said Frank
Hazevoets, CFO of ASIT biotech.
Michel Baijot, CEO of ASIT biotech, concluded:
“Administrating the last gp-ASIT+™ treatment before the start of
the pollen season, with no major safety concerns, is a great
achievement that considerably de-risks our plan to publish the
primary efficacy results by the end of this year. We believe that,
given the solid design of this pivotal study, targeting the most
allergic patients in regions that are the most exposed to grass
pollen, and by using an accurate electronic reporting system, we
can collect strong and statistically significant data that will
determine the capacity of our innovative immunotherapy to treat
such a widespread allergy. Furthermore, we are pleased to welcome
Frank Hazevoets to the management team of ASIT biotech at this key
stage of our development. His strategic vision combined to his
financial expertise will be extremely valuable for our growth. We
would also like to thank Yves Désiront for his outstanding
commitment to the Company as interim CFO during the important
transitional period we have been through, and are glad to count on
his support as a board member.”
***
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+™ - in ongoing phase III -
and house dust mite: hdm-ASIT+™), and food allergies (peanut
allergy: pnt-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 26 staff members, at its
headquarters in Brussels and its facilities 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190501006084/en/
CompanyMichel Baijot, CEOASIT biotechTel.: +32 2 264 03
90investors@asitbiotech.com
Media and Investor Relations - FranceNewCapDusan
Oresansky / Pierre LaurentTel.: +33 1 44 71 94
92asitbiotech@newcap.eu
Media Relations - BelgiumLaure-Eve MonfortTel.: +32 2 290
90 93monfort@comfi.be