Desentum announces today that DM-101-C-002, a clinical study evaluating safety and tolerability of the investigational birch pollen allergy vaccine DM-101PX, has been fully recruited and the dosing of all cohorts has been started.
DM-101-C-002 is a randomised, double-blind, placebo-controlled Phase I clinical study evaluating the safety and tolerability of three different escalating 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. The study, which is conducted in Canada, has now enrolled thirty adult subjects with documented birch pollen allergy. The dosing of the third and final cohort of the study has been started, following a positive decision by the Safety Monitoring Committee. The study is on track to be completed in Q2/2024.
“Recruitment is a critical part of a clinical study. Therefore, we are very pleased to have reached this milestone”, says Pekka Mattila, CEO of Desentum. “With a fully recruited study and all cohorts started according to the planned timeline, we are in a good position to complete the study before the birch pollen season next year. We have demonstrated in preclinical studies that this unique, slow-release formulation of DM-101 hypoallergen has a potential to drastically reduce allergic reactions that limit dose escalation in allergen immunotherapy. With the DM-101-C-002 study, we aim to demonstrate the same potential in human subjects.”
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.