In short
Dactylis glomerata pollen, depigmented polymerized extract is an investigational allergen immunotherapy substance studied for allergic rhinoconjunctivitis with or without asthma. It is part of the Depigoid product family developed by LETI PHARMA, S.L.U. Two authorised Phase 3 trials are evaluating this substance, together enrolling 667 participants, to assess whether subcutaneous injections can reduce symptoms and medication use during grass and olive pollen seasons.
Key points
- Phase 3 trials are testing Dactylis glomerata pollen, depigmented polymerized extract in allergic rhinoconjunctivitis with or without asthma.
- The GOES trial enrolled 343 participants and tests a grass and olive combination product.
- The GIRA trial enrolled 324 participants and compares two strengths of a grass-only product.
- Both trials measure a combined symptom and medication score (cSMS) on a 0–6 scale during peak pollen season.
- The substance is given by subcutaneous injection as a suspension for injection.
- It currently has no marketing authorisation and remains an investigational substance.
What is Dactylis glomerata pollen, depigmented polymerized extract?
Dactylis glomerata pollen, depigmented polymerized extract is an active substance used in allergen immunotherapy products. The full registry name of the product includes several grass pollens — Phleum pratense, Festuca elatior, Dactylis glomerata, Poa pratensis and Lolium perenne — as well as Olea europaea (olive) pollen, all in depigmented polymerized extract form. In the product records of the two trials, the substance appears under the product names Depigoid DUO Grass-Mix/Olea (1000 DPP/ml + 1000 DPP/ml), Depigoid Grass-Mix (1000 DPP/ml) and Depigoid FORTE Grass-Mix (3000 DPP/ml). It is classified in the respiratory tract diseases and immune system diseases therapeutic areas. The substance is an investigational product with no marketing authorisation in these records, supplied by LETI PHARMA, S.L.U.
How does Dactylis glomerata pollen, depigmented polymerized extract work?
The substance is a depigmented polymerized allergen extract. Depigmentation removes components that can cause immediate allergic reactions, while polymerization creates larger allergen molecules. This approach is intended to allow the immune system to build tolerance to grass and olive pollen allergens through repeated subcutaneous injections, with the aim of reducing allergic symptoms during natural pollen exposure. The exact mechanism is not described in further detail in the registry records.
Which conditions is it studied for?
- Allergic rhinoconjunctivitis with or without asthma due to grass and olive pollen sensitisation — studied in the GOES trial, which requires clinically relevant sensitisation to both grass and olive pollen.
- Allergic rhinoconjunctivitis with or without controlled asthma — studied in the GIRA trial, which focuses on grass pollen sensitisation.
How is Dactylis glomerata pollen, depigmented polymerized extract given?
The substance is formulated as a suspension for injection and is given by subcutaneous injection or subcutaneous use. In the GOES trial, the active product Depigoid DUO Grass-Mix/Olea is given as a 0.5 ml subcutaneous injection at a strength of 1000 DPP/ml for each component. In the GIRA trial, two strengths are compared: Depigoid Grass-Mix at 1000 DPP/ml and Depigoid FORTE Grass-Mix at 3000 DPP/ml, both as 0.5 ml subcutaneous injections. Both trials also use a conjunctival provocation test with grass-mix or olive extracts at 30 HEP/ml for ocular use to assess allergic response.
What do the clinical trials show?
Two authorised Phase 3 trials are evaluating Dactylis glomerata pollen, depigmented polymerized extract. Both are interventional studies with a randomised, double-blind, placebo-controlled design in their primary phase.
What does the GOES trial measure?
The GOES trial (2025-521709-42-00) enrolled 343 participants and is testing the grass and olive combination product Depigoid DUO Grass-Mix/Olea against placebo. The primary outcome is the mean combined symptom and medication score (cSMS) on a 0–6 scale during the peak grass and olive pollen season, comparing the active and placebo groups after at least 8 injections of treatment. The medication score ranges from 0 (no medication) through 0.5 (antihistamine eye drops), 1 (oral antihistamine) to 1.5 (intranasal corticoid). The symptom score ranges from 0 (none) to 3 (severe) for runny nose, sneezing, itchy nose, nasal congestion, itchy eyes and tearing.
What does the GIRA trial measure?
The GIRA trial (2025-521736-10-00) enrolled 324 participants and compares two strengths of a grass-only product — Depigoid Grass-Mix at 1000 DPP/ml and Depigoid FORTE Grass-Mix at 3000 DPP/ml — against placebo. The primary outcome in the double-blind phase is the mean cSMS on a 0–6 scale during peak grass pollen season after at least 8 injections. The medication score uses the same scale as GOES: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid. The trial also includes an open-label phase that assesses the change in the amount of allergen needed to produce a positive conjunctival provocation test after the pollen season compared to baseline.