HELSINKI, Oct. 25, 2021 /PRNewswire/ -- Desentum
Oy, a clinical-stage biopharmaceutical company developing novel
immunotherapies for treating allergies, today announced positive
First-in-Human clinical data of DM-101, its lead candidate for
treatment of birch pollen allergy. DM-101 was found to be safe and
well tolerated in a dose regimen of 5 ascending doses, and
immunological marker results indicated a favourable immunological
response.
"We are very happy to have completed the clinical study despite
the challenges posed by the Covid-19 pandemic. The preclinical
models available for testing allergen immunotherapy products are
indicative at best, so the First-in-Human clinical study was an
important milestone towards the clinical Proof-of-Concept. Although
this was an early-phase study, the results are very encouraging and
provide valuable information for planning the next study", says
Pekka Mattila, CEO of
Desentum.
The randomised, double-blinded, placebo-controlled, dose
escalation study was designed to evaluate the safety and
tolerability of subcutaneous immunotherapy with DM-101 in birch
pollen allergic adults. Immunological markers such as
allergen-specific IgE and IgG were also analysed. For the study, 27
adults with documented birch pollen allergy were enrolled and
randomised into four cohorts. The volunteers received either a
single dose or ascending doses of DM-101 or placebo.
It was concluded that the highest of the tested dosing regimens,
a biweekly dosing regimen of DM-101 involving 5 ascending doses is
safe and well-tolerated by subjects that suffer from seasonal
symptoms of birch pollen allergy. Albeit the number of study
participants was small, the immunological marker results indicated
a favourable change in the markers associated with a protective
response.
"In addition to providing safety and immunogenicity data about
DM-101, the study results also led us to investigate the effect of
formulation on the potency of the allergens. An improved
formulation of DM-101 utilising the findings is being tested in
preclinical studies and is expected to be ready for the next
clinical study that will further investigate the dosing interval
and dose levels of DM-101 in terms of safety and efficacy", says
Mattila.
"The allergen immunotherapy market needs safe, reliable and
efficient treatment options that meet the current regulatory
standards that are becoming more and more challenging in terms of
product quality and specifications. Our goal is to offer sustained
relief from allergic symptoms with a treatment that can be
completed in months instead of years. With the positive results
from the First-in-Human clinical study and the promising new
formulation we are looking forward to moving towards this goal",
concludes Mattila.
The clinical study was part of AllergyVAX project that has
received funding from the European Union's Horizon 2020 research
and innovation programme under grant agreement No 829933.
Immunotherapy in allergy treatment
Allergy is one of the most common chronic conditions in
Europe. Today, more than 150
million Europeans suffer from allergic diseases. For one in five
patients the condition is severe enough to create a constant threat
of a severe allergic reaction or an asthma attack. European Academy
of Allergy and Clinical immunology (EAACI) predicts that by 2025
allergy will affect half the population in Europe. Allergies cause social and economic
burden such as health care costs, missed school and work days and
impact on the daily lives of the patients.
Allergies are generally managed by medication that alleviates
the symptoms. The most common medications are antihistamines and
corticosteroids. Immunotherapy is the only treatment currently
known that affects the mechanism of allergy. It re-educates the
immune system to tolerate the allergen, decreasing the need for
medication. Immunotherapy can be administered as injections or
sublingual tablets or drops, and currently available treatments
usually take a few years. The novel immunotherapeutic products that
are under development aim for speeding up the treatment as well as
improving the safety, efficacy and convenience.
About Desentum Oy: Desentum is a
biopharmaceutical company based in Helsinki, Finland. It is specialized in
developing a novel type of allergen immunotherapy based on
switching the immune system's response to allergens from
hypersensitivity to tolerance by utilizing modified hypoallergens.
Desentum, founded in 2011, is a spin-off company from VTT Technical
Research Centre of Finland Ltd. In 2013 VTT received an EARTO
(European Association of Research and Technology Organisations)
Innovation Prize for the work behind the immunotherapeutic
products. In 2018, Desentum was awarded a 1,9 M€ grant from the
highly competitive Horizon 2020 SME instrument for the
first-in-human clinical trial and business development. In addition
to birch pollen allergy, Desentum develops novel treatments for
grass pollen and peanut allergies.
Contact:
Pekka Mattila,
CEO
Desentum Oy
Tel. +358-500-512934
info@desentum.fi
www.desentum.com
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