Dosing completed for Desentum's First-in-Human clinical study of DM-101
Dosing has been completed for all study subjects in Desentum’s First-in-Human clinical study of DM-101, a novel allergy vaccine intended for treating birch pollen allergy. Last follow-up visits will be completed during Q2/2021 and study results are expected in Q3/2021.
The clinical study is a randomized, double-blind, placebo-controlled study to evaluate the safety and immunogenicity of DM-101. It includes 27 birch pollen allergic individuals and is conducted in Finland by Clinical Research Services Turku Oy (CRST Oy). The study subjects have received up to five doses of DM-101 or placebo over a period of two months as subcutaneous injections. DM-101 is a modified birch pollen allergen designed for improving the immunotherapeutic treatment of birch pollen allergy.
“We are very happy that the study has successfully progressed to the completion of dosing phase”, says Pekka Mattila, CEO of Desentum. “The dosing visits were completed before the birch pollen season and only some of the follow-up visits are remaining. In this, the late spring this year worked to our advantage. We are also grateful to CRST Oy for their efforts in the recruitment of volunteers and study conduct during the challenging time of the Covid-19 pandemic.”
The study was initiated in early 2020 but was temporarily halted due to the pandemic and pollen season. It was resumed in the autumn of 2020 and the final results will be available in Q3/2021.
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 the treatment usually takes 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 Espoo, 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 a project named AllergyVAX.
Pekka Mattila, CEO
Tel. +358 500 512934