The company has said that results from the Phase I trial saw DM-101PX able to induce an allergen-specific IgG4 response. Credit: Shutterstock / Girts Ragelis.
A vaccine designed to ward against allergic reactions brought on by birch pollen has proven to be safe and well-tolerated while showing early and sustained signs of efficacy.
Finnish biopharma Desentum Oy is advancing the vaccine, dubbed DM-101PX, to Phase II studies after it announced positive results from a randomised, double-blind, placebo-controlled Phase I trial (NCT04266028).
The trial investigated the short-course treatment in patients allergic to birch pollen. According to the company, nearly all patients reached their targeted maximum dose whilst demonstrating a strong Immunoglobulin G4 (IgG4) response.
The company has said that results from the Phase I trial saw DM-101PX able to induce an allergen-specific IgG4 response, which was found to be effective at blocking immunoglobulin E (IgE).
Desentum CEO Pekka Mattila said: “We are very excited to see that a short treatment with DM-101PX is safe and able to induce a very strong protective immune response, which exceeds that of marketed Allergen immunotherapy products.
“The results endorse Desentum’s approach to designing highly efficient allergy vaccines. Based on the positive data from Phase I, we have decided to advance the product into Phase II clinical trials in which the clinical effects of treatment with DM-101PX will be investigated.”
The trial recruited 30 adult patients from a single site in Finland who were randomised into three dose escalation cohorts and a placebo group. Each cohort received ten subcutaneous injections over ten weeks. Doses escalated from ten nanograms (ng) of DM-101PX on day one, up to 100ng on days 28, 42, and 56 in the lower multiple-ascending dose (MAD) group, and up to 300ng by day 56 in the highest dose group.
According to Desentum, the active ingredient in DM-101PX is a genetically engineered version of the recombinant variant of major birch pollen, Bet v 1. Research by GlobalData estimates that the global market for pollen allergy medications brought in $84m in 2024 alone.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the world of allergy therapies, ALK’s Itulatek (birch pollen allergen extract) has met its primary endpoint in the Phase III paediatric clinical trial for treating tree-pollen-induced allergic rhinoconjunctivitis. Meanwhile, Stallergenes Greer has initiated a Phase III clinical study of Staloral Birch to treat children and adolescents with birch pollen-induced allergic rhino-conjunctivitis.
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