A scientific paper reporting the Phase 1 clinical trial results of DM-101PX has been published in the renowned journal Clinical & Experimental Allergy by Desentum together with clinical and academic collaborators. The randomised, placebo-controlled trial tested a recombinant, hypoallergenic variant of the major birch pollen allergen Bet v 1, formulated into a thermosensitive hydrogel, in adults with birch pollen allergy.
The study showed that a short course of only 10 weekly injections was well tolerated and induced a strong and functional immune response. Treatment led to a pronounced increase in Bet v 1-specific IgG4, and post-treatment sera effectively blocked basophil activation by up to 90%. Notably, this antibody response was reached within three months, compared to the 1–3 years typically needed with conventional immunotherapy.
These results support the potential of DM-101PX to offer a fast and safe path to long-term allergy relief and provide the foundation for the ongoing Phase 2 study now investigating its clinical effect on allergic symptoms.
The Open Access article can be read here: https://doi.org/10.1111/cea.70424
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
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.
Unmet need in birch pollen allergy treatment
Birch pollen is the most allergenic tree pollen and a common cause of pollen food allergy syndrome. Birch pollen allergy affects more than 100 million people in Europe and North America, causing significant social and economic burden. Allergen immunotherapy (AIT) can affect the underlying disease, but the treatment response varies between patients. The current AIT treatment regimens can also be long, burdensome, and carry a risk of anaphylaxis. There is a clear need for a short-course, safe and effective immunotherapy that can offer long-term protection from allergy.