The Canadian regulatory authority Health Canada has approved Desentum’s clinical trial application for a Phase 2 clinical study with DM-101PX, an investigational immunotherapeutic treatment for birch pollen allergy. Approximately 100 birch pollen allergic adults will be enrolled in the randomized, double-blinded, placebo-controlled trial. The objective is to demonstrate the effect of a short, preseasonal treatment on allergic symptoms and to evaluate the persistence of this effect for a period of approximately 25 weeks after treatment.
In a Phase 1 study, a 10-week treatment with DM-101PX was found to be safe and well tolerated and to induce a strong allergen-specific IgG response, which is considered protective against IgE-mediated allergic reactions. The IgG response was still detectable at a follow-up visit 28–37 weeks after the end of treatment, whereas the placebo group showed no such effect. The Phase 2 study will assess the clinical effect of DM-101PX on allergic symptoms using a nasal allergen provocation test. Additionally, it will assess the safety and tolerability of DM-101PX and its impact on immunological markers.
“The safety profile and the strong immunological response observed in the Phase 1 study are very encouraging and suggest that DM-101PX has the potential to provide long-term protection with a short-course treatment”, says Pekka Mattila, CEO of Desentum. “The regulatory approval of the Phase 2 study marks an important step in our mission to develop the product towards licensure.”
About DM-101PX
The active substance in DM-101PX is DM-101, a recombinant birch pollen allergen modified to reduce its allergenic potential. DM-101PX contains a formulation optimized to support the 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.