The German regulatory authority Paul-Ehrlich-Institut has approved Desentum’s clinical trial application for a clinical study with DM-101PX, an investigational immunotherapeutic treatment for birch pollen allergy. The study will be carried out at Fraunhofer ITEM in Hannover.
The UPSIT study is a randomized, double-blind, placebo-controlled study investigating multiple dosing strategies of DM-101PX. The study is expected to provide important insights into the selection of dosing regimens and to inform the design of a subsequent dose-finding study. Approximately 40 birch pollen allergic adults will be enrolled in the study with a primary objective to assess safety and tolerability of different dosing regimens.
The study will be carried out at Fraunhofer Institute for Toxicology and Experimental Medicine ITEM in Hannover, Germany, a leading clinical research institution with extensive experience in the development and evaluation of therapies for respiratory allergies and asthma.
“Our goal is to develop safe and effective short-course immunotherapy,” says Pekka Mattila, CEO of Desentum. “Selecting the optimal dosing regimen is key for successful clinical development, and UPSIT will give us valuable data to guide the design of our next study.”
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 Oy is a clinical-stage biopharmaceutical company based in Espoo, Finland, leveraging high-resolution protein engineering and novel formulations for designing allergen immunotherapies that enable short-course treatment to restore long-term tolerance. Desentum, founded in 2011, is a spin-off company from VTT Technical Research Centre of Finland Ltd. With its product development, Desentum targets both respiratory and food allergies.