Desentum today announces the dosing of first subjects in a clinical study evaluating safety and tolerability of its investigational birch pollen allergy vaccine DM-101PX. The study, which is conducted in Canada, also assesses the effect of DM-101PX on allergic symptoms in a pollen exposure chamber.
DM-101-C-002 is a randomised, double-blind, placebo-controlled Phase I clinical study evaluating the safety and tolerability of three different dosing regimens of the immunotherapeutic birch pollen allergy vaccine DM-101PX. The study will also assess the effect of DM-101PX on allergic symptoms by using a controlled birch pollen exposure. Thirty adult subjects with documented birch pollen allergy will be enrolled in the study, which will be completed in Q2/2024.
Pekka Mattila, CEO of Desentum, says: “We have developed a unique, slow-release formulation for DM-101. In preclinical studies, the formulation has been shown to drastically reduce dose-limiting allergic reactions typically seen during allergen immunotherapy. In combination with Desentum’s technology to design hypoallergens with preserved antigenicity and immunogenicity, we aim to demonstrate in this clinical study that DM-101PX has the potential to enable a short-course desensitisation therapy for birch pollen allergic patients. If the formulation fulfils the expectations, it can be adapted to Desentum’s other hypoallergens and possibly even find wider use in drug formulation.”
DM-101PX is an investigational medicinal product intended for immunotherapeutic treatment of birch pollen allergy. The active ingredient in DM-101PX is DM-101, a recombinant birch pollen allergen modified to reduce its allergenicity while retaining the desired immunological properties. DM-101PX has a novel formulation optimised to support the controlled release of the active ingredient after subcutaneous injection. With DM-101PX, Desentum aims to significantly reduce the number of injections required for allergen immunotherapy of birch pollen allergy while ensuring efficacy.
Desentum Oy 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. With its product development, Desentum targets both pollen and food allergies.