The Canadian regulatory authority Health Canada has approved Desentum’s clinical trial application for a clinical study on DM-101PX, an investigational preparation intended for immunotherapeutic treatment of birch pollen allergy.
The planned study will test three different dose regimens of DM-101PX for safety and tolerability and explore the effect of the product on allergic symptoms when study subjects are exposed to birch pollen in an environmental exposure chamber.
The approval highlights Desentum’s adherence to rigorous scientific and ethical standards. The DM-101-C-002 study will be carried out in Canada by Cliantha Research, a full-service Clinical Research Organization (CRO) that has also offered valuable support in the regulatory process. The study will be initiated in the upcoming weeks, and the dosing is expected to start in Q4/2023.
Pekka Mattila, CEO of Desentum, states, “In our opinion, the current options for treating allergies are suboptimal. There is an unmet need for new solutions. Offering hope to individuals dealing with allergies is our key driver when developing innovative products like DM-101PX. The clinical trial authorization is one step closer to this goal.”
The active substance in DM-101PX is DM-101, a recombinant birch pollen allergen modified to reduce its allergenic potential. DM-101PX is a formulation optimized to support a controlled release of DM-101 after subcutaneous injection.
About Desentum Oy
Desentum is a clinical-stage biopharmaceutical company based in Espoo, Finland. It is specialized in developing a novel type of allergen immunotherapies 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.