0OIR Alk Begins Clinical Trial Of Its Slit-tablet For The Treatment Of Peanut Allergy
27 June 2022 - 08:44PM
UK Regulatory
TIDMALK TIDMB
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF):
-- ALK initiates a Phase I clinical trial of its novel investigational
sublingual allergy immunotherapy (SLIT) tablet for the treatment of
peanut allergy.
-- The trial marks the formal start of clinical development of the peanut
SLIT-tablet which uses same technology as ALK's SLIT-tablets for
respiratory allergies.
ALK announced today that it is initiating Phase I clinical
development of its investigational SLIT-tablet for the treatment of
peanut allergy. Under the name Alliance, the trial will be
conducted in North America and will assess the tolerability and
safety of an up-dosing regimen with a once-daily peanut
SLIT-tablet.
ALK first announced its intention to establish a presence in the
treatment of food allergies in early 2021. Initiation of the
Alliance Phase I trial follows the successful completion of a
feasibility study in late-2021, which confirmed that the same
technology used in ALK's SLIT-tablets for respiratory allergies,
was also suitable for use in the peanut SLIT-tablet.
In all, approximately 100 adults, adolescents and children, who
have a confirmed peanut allergy, will participate in the trial,
which is expected to involve up to 15 centres. Screening of
patients will begin soon and, and the trial is scheduled to
complete in 2023.
Henrik Jacobi, ALK's Executive Vice President of R&D, said:
"Peanut allergy is an area of significant unmet medical need, and
ALK is committed to seeking new solutions that address the needs of
people who live with this potentially life-threatening condition.
We will use our profound R&D expertise, and the extensive
experience gained in the clinical development of our SLIT-tablets
for respiratory allergies, to develop a potentially valuable new
treatment option for prescribers and their peanut-allergic
patients."
The Alliance trial is a Phase I, open-label, dose-escalation,
multi-centre trial, with participants screened via double-blind,
placebo-controlled food challenges to confirm their peanut allergy.
There will be two stages to the trial. The first is designed to
determine the starting dose of the up-dosing regimen, and the
second to assess the tolerability of the up-dosing regimen. Further
objectives are to assess the safety of the peanut SLIT-tablet and,
in the second stage, to gather early data on its biological action.
The trial will consist of up to 10 cohorts, split evenly between
the two stages of the trial.
In the USA, peanut allergy affects up to 1.5 million children
and adolescents aged 4-17, while in Europe, around 1 million
children and adolescents are affected by this potentially
life-threatening condition. The disease often presents in early
childhood, and can last a lifetime. For some of these patients,
allergy immunotherapy may become a relevant treatment option with
the potential to improve quality of life, both for them and their
families.
Alongside its work to develop a peanut SLIT-tablet, ALK is also
further developing its range of respiratory SLIT-tablets in order
to extend their coverage to children and adolescents in more
markets, and is currently conducting Phase III paediatric trials of
its house dust mite and tree pollen SLIT-tablets.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile
+45 2261 2525
Media: Jeppe Ilkjær, mobile +45 3050 2014
This information is information that ALK-Abelló A/S is obliged
to make public pursuant to the EU Market Abuse Regulation.
About ALK
ALK is a global specialty pharmaceutical company focused on
allergy and allergic asthma. It markets allergy immunotherapy
treatments and other products and services for people with allergy
and allergy doctors. Headquartered in Hørsholm, Denmark, ALK
employs around 2,600 people worldwide and is listed on Nasdaq
Copenhagen. Find more information at www.alk.net.
Attachment
-- ALK_12_22UK_27062022
https://ml-eu.globenewswire.com/Resource/Download/511a8578-b0e6-4cf3-8511-4dd0fede554a
(END) Dow Jones Newswires
June 27, 2022 06:44 ET (10:44 GMT)
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