In short
Festuca elatior pollen, depigmented polymerized extract is an investigational allergen immunotherapy substance developed by LETI Pharma. It is part of fixed combination products called Depigoid, which also contain extracts from other grass pollens and olive pollen. Two authorised Phase 3 trials are currently assessing these products in a total of 667 people with allergic rhinoconjunctivitis, with or without asthma.
Key points
- Festuca elatior pollen extract is one component of Depigoid, an investigational allergen immunotherapy for grass and olive pollen allergy.
- Two Phase 3 trials are authorised to test Depigoid products in people with allergic rhinoconjunctivitis, with or without asthma.
- The trials together plan to enrol 667 participants — 343 in the GOES trial and 324 in the GIRA trial.
- Both trials compare active treatment against placebo using a combined symptom and medication score measured during peak pollen season.
- Treatment is given as a subcutaneous injection, with at least 8 injections before the main efficacy assessment.
- Both trials are currently authorised but not yet reporting results.
What is Festuca elatior pollen extract?
Festuca elatior pollen, depigmented polymerized extract is an investigational allergen immunotherapy substance. It is one of several grass pollen extracts combined in products named Depigoid, manufactured by LETI Pharma, S.L.U. The full registry name also includes depigmented polymerized extracts from Phleum pratense, Dactylis glomerata, Poa pratensis, Lolium perenne, and Olea europaea pollens.
The substance has no marketing authorisation in the product records, meaning it is still an investigational medicine. It is part of fixed combination products in three product records. The product names are 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).
How does Festuca elatior pollen extract work?
Allergen immunotherapy works by exposing the immune system to gradually increasing amounts of a modified allergen. The extract in Depigoid is described as depigmented and polymerized, meaning the allergen proteins have been chemically altered to reduce their ability to trigger allergic reactions while still training the immune system to tolerate them. The trials do not provide further details on the exact molecular mechanism.
Which conditions is it used or studied for?
- Allergic rhinoconjunctivitis with or without asthma due to grass and olive pollen sensitisation — the GOES trial studies people with clinically relevant sensitisation to both grass and olive pollen.
- Allergic rhinoconjunctivitis with or without controlled asthma — the GIRA trial studies people sensitised to grass pollen, with or without controlled asthma.
The therapeutic area is recorded as respiratory tract diseases and immune system diseases.
How is Festuca elatior pollen extract given?
The Depigoid products are formulated as a suspension for injection and are given by subcutaneous injection. The trial records describe a dose of 0.5 ml per injection. The GOES trial uses Depigoid DUO Grass-Mix/Olea at 1000 DPP/ml for each component, while the GIRA trial tests two concentrations: Depigoid Grass-Mix at 1000 DPP/ml and Depigoid FORTE Grass-Mix at 3000 DPP/ml.
What do the clinical trials show?
Two Phase 3 trials are authorised for these Depigoid products, with a combined planned enrolment of 667 participants. Both trials are interventional and compare active treatment against placebo. Neither trial has reported results yet, as both are in the authorised stage.
| Trial identifier | Phase | Condition | Status | Participants |
|---|---|---|---|---|
| 2025-521709-42-00 | Phase 3 | Allergic rhinoconjunctivitis with or without asthma due to grass and olive pollen | Authorised | 343 |
| 2025-521736-10-00 | Phase 3 | Allergic rhinoconjunctivitis with or without controlled asthma | Authorised | 324 |
Who can take part in these trials?
The GOES trial enrols people with allergic rhinoconjunctivitis, with or without asthma, who have clinically relevant sensitisation to both grass and olive pollen. The GIRA trial enrols people with allergic rhinoconjunctivitis, with or without controlled asthma, who are sensitised to grass pollen. The trial records do not list detailed inclusion or exclusion criteria beyond these condition descriptions.
What are the trials measuring?
Both trials use a combined symptom and medication score (cSMS) on a scale from 0 to 6, collected through a mobile app during the peak pollen season. The medication score ranges from 0 (no medication) to 1.5 (intranasal corticoid), and the symptom score ranges from 0 (none) to 3 (severe) for symptoms including runny nose, sneezing, itchy nose, nasal congestion, itchy eyes, and tearing. The main comparison is between active and placebo groups after at least 8 injections of treatment. The GIRA trial also includes an open-label phase measuring the change in allergen amount needed to produce a positive conjunctival provocation test after the pollen season compared to baseline.
What side effects are known?
The trial records do not include information on side effects for these Depigoid products. No supplementary sources on side effects were provided.